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Keeping Pace with MUTATING VIRUSES
A surge in the pandemic has forced the pharma industry to deliver a wide-spectrum vaccine to fight mutation-prone SARS-CoV-2, pledging to prevent future outbreaks. WHO states that the
most extensive vaccination campaign in history is providing prophylactic results by delivering more than 12 billion doses of the COVID-19 vaccine, protecting 60 per cent of the global population as of June 2022. Now the next-generation COVID-19 vaccines are countering the
challenge of enhancing the immune response to tackle the emerging COVID-19 variants. It is therefore imperative to remain vigilant and upgrade vaccine candidates to emerging virus sublineages. In order to gain a competitive position in the market, vaccine manufacturers are
investing in advanced platform technologies. Let’s take a closer look at some of these leading vaccines approved in APAC as broad spectrum virucide inhibitors.

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Published by MMA Media, 2022-07-29 02:32:51

BioSpectrum Asia August 2022

Keeping Pace with MUTATING VIRUSES
A surge in the pandemic has forced the pharma industry to deliver a wide-spectrum vaccine to fight mutation-prone SARS-CoV-2, pledging to prevent future outbreaks. WHO states that the
most extensive vaccination campaign in history is providing prophylactic results by delivering more than 12 billion doses of the COVID-19 vaccine, protecting 60 per cent of the global population as of June 2022. Now the next-generation COVID-19 vaccines are countering the
challenge of enhancing the immune response to tackle the emerging COVID-19 variants. It is therefore imperative to remain vigilant and upgrade vaccine candidates to emerging virus sublineages. In order to gain a competitive position in the market, vaccine manufacturers are
investing in advanced platform technologies. Let’s take a closer look at some of these leading vaccines approved in APAC as broad spectrum virucide inhibitors.

Keywords: Virus Mutation,Covid-19 vaccine

Biospectrum Cla
Asia Excellence abo
eco
Awards 2022 Ma

Brought to you by: Da
als
Technology Partners: Dig
inn

Industry Partners: Dr.
im
THE 2022 AWARDS ARE JUDGED BY AN ESTEEMED PANEL He
OF INDUSTRY LEADERS AND EXPERTS! fou
Fou
Ind

The Executive Director of the Genome Institute of Singapore, Professor at Duke-NUS
Medical School Singapore and Executive Director of PRECISE, Prof. Patrick Tan is also an
elected member of the American Society for Clinical Investigation (ASCI) and a Board
Member of the International Gastric Cancer Association from Singapore.

Clare Blain, Chief Executive Officer of Life Sciences Queensland, Australia (LSQ) is passionate
about highlighting the integral role life science innovation plays in Queensland's diverse
economy. She has been a Chief Operating Officer and Operations Manager at LSQ from
Marketing Manager at Queensland Clinical Trials Network.

A Physician Scientist, Professor at Christian Medical College, Vellore (India) and
Laboratory Director, Gagandeep Kang. Is the first Indian woman to be elected to the
Fellowship of the American Academy of Microbiology and to the Royal Society and the
only physician-scientist to receive the Infosys Award in Life Sciences.

Dario Heymann, founding member and Chief Research Officer of Galen Growth, Singapore has
also successfully built HealthTech Alpha; the world's only analytics platform dedicated to
Digital Health, delivering accurate and regularly curated information to investors, industry
innovation leaders and startup CxOs.

The Director at Hello Tomorrow Asia Pacific, Xin Yi Tow from Singapore was also an
investment banker. Her expertise in investment, private equity, capital, and asset
management inspired her to co-found Slate Alt, an ecosystem of alternative investors,
future-forward innovators, and curious tech experts.

Dr. Satya Dash is a national innovation ecosystem designer, technology strategist, policy and
implementation expert, Board Member at Venture Center, Pune, India's largest S&T incubator.
He contributed to the growth of the Indian biotech & medtech innovation landscape as the
founding Head Strategy at DBT-BIRAC & In-Charge Head of IP & TT. Recently, he joined as the
Founding CEO of BITS BioCyTiH Foundation, funded by the Department of S & T, Government of
India.

Haven't Filled Your Entries Yet? Nominate Now

For more informa�on, visit: www.biospectrumasia.com/bsa-awards

4 BIO EDIT

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Dr Milind Kokje RESUSCITATING MED TOURISM

Chief Editor It looks like, slowly but surely, all countries are leaving no stone unturned to get
their economy a well deserved booster. One sector in healthcare in Asia hoping to
[email protected] rebound soon is medical tourism. Many countries in Asia are gearing up to welcome
global clients looking for medical interventions, something that went on a forced hiatus
for two years due to the pandemic.

The medical tourism sector suffered during the pandemic due to two reasons. First,
the obvious one was the ban on international travel and the shutting down of borders,
along with people’s unwillingness to travel. The second reason was that all the medical
and healthcare resources in each country had to be diverted toward handling COVID-19
inpatients. For instance, Malaysia Health Tourism Council (MHTC), the government’s
arm for medical tourism, had expected 200,000 patients - 33 per cent more than 2019
- to arrive for medical procedures in 2020 and prepared accordingly. It even organised
events abroad to promote the country’s medical tourism and attract patients. MHTC
organised the Malaysia Year of Healthcare Travel (MyHT2020) campaign in 2020 to
generate RM2.8 billion (USD673m) revenue from medical tourism and a spillover of
RM6 billion in medical receipts. But it had to defer the campaign due to the pandemic.

The Association of Private Hospitals of Malaysia reported that the number of medical
tourists was almost nil. Although, now, there are signs of recovery, it is estimated to
take another three years as by 2025 healthcare tourism revenue of Malaysia could
match to the pre-pandemic levels of RM7 billion Malaysian Ringgit (RM). Even in
a poll conducted by Verdict, 26 per cent respondents have estimated that the sector
would take two to three years to bounce back to pre-pandemic level.

A paper published by journalist Megan Tatum in the BMJ reported that Thailand,
which attracts the maximum number of medical tourists in the ASEAN countries
clocking $1.8 billion in revenue in 2019, has planned to grow the sector by 5 per cent
in the current year. Singapore has set aside SGD 500 million to support the recovery of
tourism and it is estimated that by 2025, the global wellness tourism market will reach
USD 1.1 trillion according to Global Wellness Institute.

Asia has been the most attractive region for medical tourism, pulling clientele from
across the world for nearly the past decade. Aside from the non-availability of certain
procedures in some countries, the cost-effectiveness of treatments have been attracting
patients to Asia. For instance, just to compare the cost involved for a bypass surgery,
in India it costs around $10,000 as against $113,000 in the US as per the Skyquestt
market report.

If the figures of Thailand and Malaysia alone are looked at, in 2017, 3.3 million
medical tourists visited Thailand and 1 million Malaysia. The Asia Pacific medical
tourism market is expected to be $9.53 billion in the current year and will grow at 22.4
per cent CAGR till 2027 taking it to $26.20 billion, Market Data Forecast has reported.

The Medical Tourism Association (MAT) reported that 14 million individuals
worldwide normally travel abroad for medical treatment annually. Within the medical
tourism sector, the fastest growing category is fertility tourism. This was severely
affected during the pandemic as globally the international travel decreased by 87 per
cent from January 2020 to January 2021. Though it has started picking up now.

Realising the growing importance of the medical tourism sector in the economies of
the Asian countries, Indonesia, too, has decided to make Bali an international medical
tourism destination. To make this happen the government has planned to build four
health service centres of international standard in Bali.

Besides the efforts of countries already known for medical tourism to regrow the
business, even late entrants like Indonesia are eyeing this lucrative sector and planning
to launch medical tourism, alongside its already thriving ‘regular’ tourism. The scene is
set for a medical tourism showdown in Asia, hopefully reversing two years of economic
depression.

BIO MAIL 5

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Acknowledgements/ Feedback Thank you very much for publishing the
The Qiagen coverage in both print piece on Takeda with Eileen Ang- Head of
and online versions of BioSpectrum Regulatory Affairs at APAC! Overall, we are
Asia looks good. Qiagen’s goal is very happy with the piece.
to gradually shift the focus in the
direction of preventive testing and - Jennifer Lang, Singapore
treatment to protect individuals from The article by EPM Scientific titled
tuberculosis (TB) reactivation, and ‘From Hazy to Crystal Clear Picture of
therefore prevent the spread of TB to Compensation Trends by Kayleigh Regan
others. Thank you. looks amazing. Thank you BioSpectrum Asia.

- Patrick Che, Singapore - Katrina Chui, Australia
BioSpectrum has been doing a great Corrigendum
job in bringing out all important news Along with a news titled ‘Shimadzu releases
and analysis with great dexterity. Our high-performance LCMS-2050’ covered
congratulations for continuously on page no 49 in the July 2022 issue, we
maintaining a high standard. covered the image of LCMS-2020 instead of
LCMS-2050. The error is regretted. Editor
- Dr M H Mehta, India

Vol 17; Issue 8; August 2022 MM Activ Singapore Pte. Ltd. Taiwan
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6 BIO CONTENT BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

COVER STORY 21

Keeping Pace with

MUTATING
VIRUSES

A surge in the pandemic has forced the pharma industry to deliver a wide-spectrum vaccine to
fight mutation-prone SARS-CoV-2, pledging to prevent future outbreaks. WHO states that the
most extensive vaccination campaign in history is providing prophylactic results by delivering

more than 12 billion doses of the COVID-19 vaccine, protecting 60 per cent of the global
population as of June 2022. Now the next-generation COVID-19 vaccines are countering the
challenge of enhancing the immune response to tackle the emerging COVID-19 variants. It
is therefore imperative to remain vigilant and upgrade vaccine candidates to emerging virus
sublineages. In order to gain a competitive position in the market, vaccine manufacturers are
investing in advanced platform technologies. Let’s take a closer look at some of these leading

vaccines approved in APAC as broad spectrum virucide inhibitors.

BIO CONTENT 7

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com SPEAKING WITH

CDMOs 37

29 “An effective biobank
provides high-quality and
How CDMOs are Adapting affordable biospecimens to
to New mRNA Tech Demands drive research, aiding live-
PHARMA 4.0 saving scientific discoveries”

31 Erik Steinfelder,
Global Enterprise Relationship Lead,
Is Industry 4.0 Promising The Moon? Thermo Fisher Scientific
DRONES
39
33
“Unique demands of
Providing Succour By UAVs CGT biomanufacturing
AWARDS necessitate an early-stage
collaboration between
47 suppliers and
biomanufacturers”
MM Activ bags recognition
for exhibition excellence Narayana Rao,
Vice President of Biopharma,
Asia Pacific Middle-East Africa, Avantor

41

“Many countries in
APAC lack digital
infrastructure to store and
process data efficiently”

Chris Khang,
President & Chief Executive Officer,
(ASEAN, Korea and ANZ), GE Healthcare

REGULARS

BioEdit.........................................................................04

BioMail........................................................................05

Policy and Regulatory News...................................08

Company News........................................................10

Finance News............................................................12

Start-Up News...........................................................13

People News..............................................................43

R&D News..................................................................46

Supplier News...........................................................48

Lets Talk Health........................................................50

8 REGULATORY NEWS

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

India, Singapore join hands
for technology innovations

The Union Cabinet chaired innovation and entrepreneurship through collaboration. The
by Indian Prime Minister in both countries leading to new activities envisaged in the MoU
Narendra Modi was apprised of a technology creation, manpower will involve product development
Memorandum of Understanding training and IP generation through and technology exchange which
(MoU) signed between the collaboration. The new knowledge may lead to the generation of new
Department of Science and and technology development enterprises and employment. The
Technology of the Republic of through activities implemented objective of this memorandum
India and the Ministry of Trade under this cooperation will is to encourage, develop and
and Industry of the Government provide impetus to Atmanirbhar facilitate cooperation between
of the Republic of Singapore on Bharat. The MoU will provide a India and Singapore in fields
Cooperation in the fields of Science, mechanism and help in creating of common interest in science,
Technology and Innovation. The an ecosystem that will promote technology and innovation.
MoU was signed in February innovation and entrepreneurship
2022. The MoU will provide a in both countries leading to new
mechanism and help in creating technology creation, manpower
an ecosystem that will promote training and IP generation

Australia widens access New Zealand backs
to COVID-19 treatments study for safer
alternative to opioids
All Australians aged over 70 who test positive to COVID-19
will be able to access antivirals on the Pharmaceutical The Health Research Council of New
Benefits Scheme (PBS). Access will also be expanded to Zealand (HRC), a crown agency of the
people aged over 50 with two or more risk factors for severe New Zealand government responsible for
disease, Aboriginal or Torres Strait Islander people aged managing the government’s investment
over 30 with two or more risk factors for severe disease. in health research for the public good, is
Immunocompromised people over 18 may also be eligible. backing the concept for safer alternatives
COVID-19 can be very serious for adults in high-risk groups, to opioids. A New Zealand-led research
even when they are fully vaccinated. For these people, new team that has developed a suite of non-
oral antiviral treatments help keep people out of hospital, addictive drug compounds to treat pain
reduce the pressure on our health system, and can save has received a funding boost to progress
lives. More than 73,000 Australians have already benefited their work through the preclinical
from these medicines. The Pharmaceutical Benefits development phase. The team received one
Advisory Committee (PBAC) recommended the changes of 53 grants announced by the HRC in a
in response to the latest evidence on the effectiveness $78.92 million funding allocation for new
and safety of the medicines, current usage data and the and innovative research into some of New
changing epidemiology of COVID-19. Following PBAC’s Zealand’s most pressing health concerns.
advice, the government has also expanded the criteria The team will use a $1.2 million project
to include people who have a broader range of chronic grant to find the most effective and safe
respiratory issues. There is also greater access for adults compound from their novel drug library
living with disability who have multiple medical conditions. for treating chronic pain. The research
team will help develop the novel drugs
and use innovative technology to ‘map’
pain in the brain and see how the drugs
mitigate that pain. One in five adults in
New Zealand suffers from chronic pain and
half of pain sufferers report little pain relief
with current treatments.

REGULATORY NEWS 9

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Singapore approves GSK’s China approves
new ovarian cancer therapy
treatment for
GlaxoSmithKline (GSK) Singapore has announced
that Health Sciences Authority has approved Zejula chronic non-infectious
(niraparib) tablet, an oral, once-daily first-line and
recurrent maintenance treatment for women with eye inflammation
advanced epithelial high-grade ovarian, fallopian tube or
primary peritoneal cancer who are in complete or partial Ocumension Therapeutics has announced
response following platinum-based chemotherapy. This that the New Drug Application (NDA) for the
new product registration makes Zejula the only poly core product in its pipeline, OT-401 (Sterile
(ADP-ribose) polymerase (PARP) inhibitor approved in non-bioerodible intravitreal implant, Product
Singapore for use as a monotherapy for patients with name: YUTIO), has been officially approved
advanced and recurrent ovarian cancer, regardless of by the China’s National Medical Products
whether they have a BRCA mutation. Zejula is available Administration (NMPA)
for first-line ovarian cancer (PRIMA) in 44 countries for the treatment of
and 2 Special Administrative Regions as of March 2022. chronic non-infectious
Zejula is also being assessed across multiple tumour uveitis involving the
types and evaluated in combinations with several other posterior segment of the
therapeutics. Notably, it is currently being tested in eye (chronic NIU-PS).
a Phase III clinical trial, ZEST, exploring its further This is the first new drug
potential in treating patients with triple-negative in Ocumension’s pipeline
breast cancer (TNBC) or BRCAm HER2- breast cancer, to be approved for marketing and is currently
mutations which require specialised treatment. the potential best-in-class therapy for the
treatment of this indication in China. Non-
infectious uveitis is a chronic form of uveitis
that can lead to a variety of complications
such as cataracts and glaucoma, and when the
inflammation is not promptly controlled, it can
also lead to impaired vision or even permanent
vision loss. The complexity of the clinical
presentation of non-infectious uveitis and the
high degree of similarity between subtypes pose
significant diagnostic and differential problems.

Korea accelerates vaccine sovereignty by
developing domestic COVID-19 vaccines

SK bioscience has announced for Epidemic Preparedness Imports & Exports’ report
that ‘SKYCovione,’ South Korea’s Innovations (CEPI). The market published by Biotechnology
first COVID-19 vaccine candidate expects that SKYCovione will Industry Organization in March,
adjuvanted with GSK’s pandemic accelerate securing Korea’s South Korea´s vaccine imports
adjuvant has been authorised vaccine sovereignty and reducing amounted to $2.355 billion, which
by the Korean Ministry of Food dependence on vaccine imports. was 4.5 times the export value
and Drug Safety (KMFDS). According to the ‘Global Vaccine ($519 million). Experts explain
South Korea has become one of Markets & Korea´s Vaccine that the export volume, which
the few countries in the world was only $183 million in 2017, has
to have both a domestically nearly tripled due to the contract
developed COVID-19 vaccine and manufacturing of COVID-19
a treatment. The development of vaccines, but there is still a large
SKYCovione has been supported gap between imports and exports,
by funding from the Bill & Melinda so securing a domestic vaccine will
Gates Foundation & Coalition be crucial.

10 COMPANY NEWS

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Fujitsu develops Indian Immunologicals
technology for
accurately estimating opens facility in New
postures of human body
Zealand for sterile
Japan-based Fujitsu has successfully developed a new
technology to accurately estimate postures of the human filtered serum
body from coarse-grained point cloud data obtained with
a conventional millimetre-wave sensor. The company Pristine Biologicals NZ, a subsidiary of Indian
plans to deploy the newly developed technology at Immunologicals Ltd (IIL) has inaugurated a
hospitals and nursing care facilities to support nurses new facility in Dargaville for the production of
sterile-filtered serum. Pristine was established
and caregivers in visually in Dargaville, Kaipara District in 2015 for the
monitoring patients and reacting production and supply of pharmaceutical grade
to emergency situations such as bovine serum used to produce many vaccines
falls of patients. The technology and is considered a very successful venture. It
leverages an AI model for highly is pertinent to note that the serum from New
accurate estimations of postures Zealand and Australia have premium value
of the human body and Fujitsu’s since those countries are free from OIE listed
‘Actlyzer’ artificial intelligent (AI) diseases. Pristine has been able to produce
technology for analysis of complex and supply several hundred tonnes of quality
human behaviours to analyse the serum to Indian Immunologicals in India and
movement of patients in detail other countries. The requirement for bovine
before and after a fall without installing cameras in highly serum from New Zealand for use in biologics
private spaces such as hospitals and nursing homes. manufacture has gone up many folds and to
Fujitsu will conduct field trials with hospitals and nursing meet the demands of the world market, it is
care facilities to verify the effectiveness and improve the important to augment the capacities and also
accuracy of the new technology with an aim to offer it as bring in more value-added products. Many
a service to the Japanese market by the end of FY 2023. vaccine manufacturers in India have expressed
difficulty in obtaining quality serum and have
sought the help of IIL through the government.

Smith+Nephew unveils manufacturing facility
in Malaysia to support orthopaedics biz

Smith+Nephew, the global the Malaysian Investment Growth’ pillar to strengthen its
medical technology company, has Development Authority (MIDA) foundation, this new facility will
opened its new high technology and Dr Deepak Nath, CEO of enable Smith+Nephew to serve
manufacturing facility in Batu Smith+Nephew. Aligned to the customers and their patients
Kawan Industrial Park in company’s refreshed ‘Strategy for sustainably through advanced
Penang, Malaysia. The 250,000 manufacturing. Up to 800 new
sq ft facility, worth more than local jobs in manufacturing,
$100 million in investment, will engineering and supply chain
primarily support the company’s will be created over the next few
Orthopaedics business, which years with key roles already filled.
is expected to grow strongly Malaysia is well-positioned to be
in the Asia Pacific region. The the manufacturing hub for the
new manufacturing facility medical devices industry in Asia.
was officiated by the Chief Presently, Malaysia is home to
Minister of Penang, Chow over 200 manufacturers, with
Kon Yeow, in the presence of more than 30 medical devices
Arham Abdul Rahman, Chief MNCs producing high value-
Executive Officer (CEO) of added medical devices.

COMPANY NEWS 11

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Cordlife, AMILI Samyang Holdings
Biopharma offers new
launch first-ever gut filler for dermatologists

microbiome banking Research results confirm the long-term safety and efficacy
of the new Lafullen filler from South Korea-based Samyang
service in SE Asia Holdings Biopharmaceutical Division. A dermal filler is a safe
and proven medical device that is injected into the
Cordlife Group, a Singapore Exchange subcutaneous fat layer of the skin to add volume
mainboard listed consumer healthcare and fill in facial wrinkles for a smoother, more
company, and AMILI, have announced youthful appearance. Scientific
a strategic partnership to provide the research has confirmed the
first-ever gut microbiome banking duration of efficacy, safety
service in Singapore and the region. and stability of Lafullen. The
This partnership synergises the two results of the study are being
company’s core specialisations, gut used to refine the treatment
microbiome processing and analysis protocol to ensure the highest
by AMILI and cryopreservation by standards of safety and
Cordlife, to allow people in Singapore efficacy for use by national and
to store their gut microbiome for future international dermatologists.
faecal microbiota transplants (FMT). The development of Lafullen,
The gut microbiome banking service is an injectable dermal filler
marketed by Cordlife through its wholly from the biopharmaceutical
owned subsidiary Cordlife Technologies. division of Samyang Holdings,
In this collaboration, AMILI will be began in 2015 and received
responsible for testing and processing marketing approval from
of the gut microbiome obtained from the Ministry of Food and Drug Safety
clients’ stool samples before sending in 2021. Lafullen is made of PCL
them to Cordlife’s facility in Singapore (polycaprolactone), a material biodegradable polymer for
for long-term cryopreservation. The medical use, as its main component. Using proprietary
foundation of this strategic partnership technology from Samyang Holdings Biopharmaceutical
stems from mounting evidence Division, Lafullen has less irritation compared to existing PCL
suggesting that FMT is a promising fillers, and natural volume can be expected.
approach for a myriad of diseases such
as colorectal cancer, autism spectrum
disorder, and even obesity.

MiRXES launches world’s first research
project for multi-cancer screening test

Singapore-based MiRXES has focused to discover and validate biomarkers for this purpose. It
launched the world’s first large- novel combinations of blood- will receive an investment of an
scale clinical research Project, borne circulating microRNA estimated S$50 million and more
CADENCE (CAncer Detected (miRNA) and DNA methylation by MiRXES over a three-year
Early caN be CurEd). Project period, with substantial in-kind
CADENCE aims to develop a contributions from Singapore’s
multi-cancer early detection test institutes of higher learning
for up to nine high incidence and (IHLs) and public healthcare
high mortality cancers, including institutions (PHIs). The project
lung, breast, colorectal, liver, will also see the creation of more
stomach (gastric), esophageal, than 80 new positions in research,
ovarian, pancreatic, and prostate manufacturing, and data science
cancers. Project CADENCE is over the next three years.

12 FINANCE NEWS BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

EditForce & Athenex sells Chinese
API business for $19M
Mitsubishi
Athenex, Inc., a global biopharmaceutical company dedicated to the discovery,
ink gene development, and commercialisation of novel therapies for the treatment
of cancer and related conditions, has announced that Athenex and certain
therapy deal affiliates have entered into an agreement to sell all of its equity interests in
its China subsidiaries, which are primarily engaged in Active Pharmaceutical
for ¥20 B Ingredient (API) manufacturing operations, to TiHe Capital (Beijing) for RMB
124.4 million, or approximately $19 million. Athenex will receive at least 70 per
Japan-based EditForce cent of the proceeds at closing, followed by 20 per cent within three months
has entered into a after the closing date, and the remaining balance within six months after the
license agreement closing date. Proceeds from the transaction will be used in part toward repaying
with Mitsubishi existing debt and operating the business. The deal is subject to customary
Tanabe Pharma closing conditions, including obtaining certain regulatory approvals in China.
Corporation (MTPC) to Athenex and TiHe also plan to enter into a long-term supply agreement for
research, develop and the manufacture and supply of certain API products. Following the sale of its
commercialize potential Dunkirk facility, as well as the sale of the US and European tirbanibulin royalty
gene therapy products for and milestone interests, the Athenex team continues to execute on its strategy
a specific target disease to monetise non-core assets, bolster balance sheet, extend cash runway, and
in the field of CNS by focus on potential best-in-class NKT cell therapy programme.
utilising EditForce’s
proprietary PPR protein Fujifilm invests $1.6B to
platform technology. expand global offering of cell
In this alliance, MTPC culture manufacturing services
and EditForce aim to
create potential novel Japan-based Fujifilm Corporation has announced the investment of $1.6
pharmaceuticals for the billion to enhance and expand the cell culture manufacturing services of
specific CNS disease by Fujifilm Diosynth Biotechnologies, a subsidiary of Fujifilm Corporation,
utilizing the drug R&D
know-how and global and world-leading contract development
business experience and manufacturing organisation (CDMO).
of MTPC and the This investment will enhance Fujifilm
novel biotechnology of Diosynth Biotechnologies’ sites in Hillerod,
EditForce. MTPC will Denmark, and Texas in the United States. As
acquire the exclusive part of this investment, Fujifilm Diosynth
right to conduct the Biotechnologies is further expanding its
selection of drug capacity to support large-scale cGMP fed
candidate molecules, batch production by adding 8 x 20,000L
preclinical and bioreactors and two downstream processing
clinical development, streams in its Hillerod, Denmark facility.
manufacturing, and The additional production capacity
commercialization will make the Hillerod facility the largest end-to-end CDMO in Europe,
worldwide. Under the offering a total of 20 x 20,000L bioreactors for drug substance production
terms of the Agreement, complimented by comprehensive drug product and finished goods services.
EditForce will receive The investment is expected to create approximately 450 jobs.
an upfront payment and
milestone payments
amounting to over 20
billion yen depending on
the development stage
and commercialization
progress, and royalties
based on worldwide sales
after the launch.

START-UP NEWS 13

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Huili Biotechnology Mylab launches
COVID-19 test to detect
completes Series A all variants in 20 seconds

financing Indian startup Mylab Discovery Solutions and US-
based Hemex Health, a medical diagnostic device
Jiangsu Huili Biotechnology, a next-generation company focussed on creating diagnostics to transform
synthetic biology enzyme computational frontline healthcare, have announced the official launch
design platform, has recently announced the of the Gazelle PathoCatch COVID-19 FIA test, their
completion of its Series A financing round collaborative diagnostic solution for point-of-care (PoC)
with hundreds of million RMB. This financing
round was co-led by Legend Capital and the testing in India. This portable,
fresh capital will be used to accelerate the lightweight test detects all
construction and operation of large-scale COVID-19 variants in 20
production facilities, the R&D of new product seconds with 99.4 per cent
pipelines and the expansion of the talent accuracy compared to the
team. Founded in 2018, Huili Bio is dedicated gold standard, PCR. The
to the computational design of enzyme diagnostic is currently
components at the core of synthetic biological under review with the
reactions. With cutting-edge achievements, US FDA for Emergency
Huili Bio is one of the few bio-manufacturing Use Authorisation and
companies with comprehensive capabilities in
core technology, mass production on a large will launch in Africa and the
scale and closed-loop commercialisation. Middle East later this summer.
It provides solutions in multiple fields such The Gazelle PathoCatch test
as pharmaceutical intermediates, animal includes a fluorescent lateral flow
protection and food. In addition to an immunoassay (FIA) and a reader that utilises image-
R&D centre in Tianjin, Huili Bio has also recognition software for the detection of nucleocapsid
established a production base in Taizhou protein from SARS-CoV-2. The reader uses AI imaging
City, Jiangsu Province, which is under the and signal-to-noise enhancement techniques to achieve
expansion of flexible production lines. near-PCR accuracy. Specimens are collected using a
nasal swab.

Lunit teams up with FujiFilm Thailand &
Microsoft for AI-based cancer screening

South Korea-based startup hospital using Microsoft Azure, a are annually taken in the hospital.
Lunit has signed a contract with global cloud computing platform. Through AI, Bumrungrad aims to
FujiFilm Thailand and Microsoft Lunit and Microsoft have been provide better services by timely
to supply artificial intelligent partnering to deliver state-of-the- detection of chest abnormalities
(AI) cancer screening products art medical AI technology to more and breast cancer.
to Bumrungrad International diagnostic practices globally.
Hospital, located in Bangkok, Based on previous collaboration
Thailand. Under the agreement, experiences, Microsoft Azure will
Lunit INSIGHT CXR, a CE- enhance the operation of Lunit’s
marked chest x-ray analysis AI software at Bumrungrad hospital.
software, and Lunit INSIGHT Currently, the hospital is actively
MMG, an FDA-cleared AI solution using Lunit AI solutions in its
for detecting breast cancer in check-ups, intensive care units,
early stages, are deployed in emergency rooms, and more.
Bumrungrad hospital. Lunit Lunit INSIGHT CXR and Lunit
and FujiFilm Thailand supply INSIGHT MMG analyse more
AI solutions to Bumrungrad than 100,000 medical images that

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Mesh Bio Japanese 3D-printed
prosthetic legs maker Instalimb
addresses chronic forays into Indian market

metabolic diseases Japan-based world’s first 3D-printed prosthetic legs maker
Instalimb raised 445 million yen in Series A funding in Japan
within Asia (including investment, loans, and grants) to foray into the Indian
market and launched its technologically advanced prosthetic
London-based MultiOmic wear solutions in Gurugram on July 1. Instalimb promises value
Health, an artificial intelligence proposition to the Indian market by revolutionising prosthetic
(AI)-enabled drug discovery socket fit and production process that is widely scalable, does
company, and Mesh Bio, a digital not require much space and does not require manpower with
health startup in Singapore, have specialised skill. This game changing startup aims to deliver the
announced their partnership to highest-quality prosthesis leg with socket and alignment to 48
conduct an observational clinical million people who currently do not have access to a device in the
study on patients with chronic world. Selected as a ‘J-startup’ by the Japanese
metabolic disease and increased government as one of the best technology
risk of complications such as startups in Japan, Instalimb products are
chronic kidney disease. The inspired by 3D and artificial intelligence (AI)
partnership will provide access to technology
data from patient populations in that offers the
Asia that have historically been much-needed
underrepresented in chronic comfort and
metabolic disease studies. Mesh desired fit
will collaborate with its network for the end
of healthcare provider customers users.
to recruit patients for the study.
MultiOmic will generate genomic,
proteomic, metabolomic and
potentially other omics data from
anonymized body fluid samples.

Sanofi, Health2Sync develop digital health
solutions for diabetes management in Japan

Sanofi Japan and Taiwan-based healthcare providers and patients healthcare professionals and
startup Health2Sync have entered on insulin in Japan that will patients and have witnessed
into a partnering agreement to help improve Hypoglycemia/ a good adoption within more
support healthcare professionals Hyperglycemia insulin than 200 clinics and more than
and people living with diabetes management by connected 10,000 insulin patients having
mellitus through digital support caps for insulin, and titration already joined the programme
programmes. Health2Sync, a alerts, to people living with as of May 2022. This agreement
digital health startup, specialising diabetes. The two companies in Japan again emphasises the
in diabetes and other chronic initiated their collaboration in companies’ ambition to realise
disease management, has Taiwan in September 2020 by a more comprehensive chronic
developed a healthcare/lifestyle disease management through
app that has been used providing digital health digital solutions. Moving forward,
by about 290,000 users solutions to
in Japan. Through this Sanofi and Health2Sync plan to
partnering agreement, further collaborate in bringing
Sanofi and Health2Sync will innovative digital therapeutics
work together to develop solutions to patients and
digitised features for healthcare professionals in
Japan and other markets.













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Keeping Pace with

MUTATING
VIRUSES
A surge in the pandemic has forced the pharma industry to deliver a wide-spectrum vaccine to
fight mutation-prone SARS-CoV-2, pledging to prevent future outbreaks. WHO states that the most

extensive vaccination campaign in history is providing prophylactic results by delivering more
than 12 billion doses of the COVID-19 vaccine, protecting 60 per cent of the global population
as of June 2022. Now the next-generation COVID-19 vaccines are countering the challenge
of enhancing the immune response to tackle the emerging COVID-19 variants. It is therefore
imperative to remain vigilant and upgrade vaccine candidates to emerging virus sublineages.
In order to gain a competitive position in the market, vaccine manufacturers are investing in
advanced platform technologies. Let’s take a closer look at some of these leading vaccines

approved in APAC as broad spectrum virucide inhibitors.

As of July 2022, uncertainty persists as waves Organisation (WHO) has granted 11 vaccines
of SARS-CoV-2 continue to emerge. Over an Emergency Use Listing (EUL) for global
time, new virus variants arise and threaten usage. Around 40 vaccines have been approved,
to reduce the impact of existing vaccine efforts. authorised, licensed, granted Emergency Use
There is a clear need for potential strategies to tackle Authorisation (EUA) by at least one country,
emerging variants, and to protect populations against or made available for
the future pandemic. use outside of clinical
trials via any pathway
Over the past 30 months, the development of by a regulatory
the vaccine has been a prolonged and arduous agency, a national
process for the biopharma industry across the globe. authority, or another
The companies are investing in large production entity. As per the
infrastructures with widespread distribution and records, at least one
are steadfast in bringing the COVID-19 vaccine to COVID-19 vaccine
market. The global industry stakeholders share of any type has been
next-generation vaccine platforms by leveraging the approved in 197
capabilities and long-standing expertise of innovation countries. Further,
to overcome the competitive barriers. An enviable there are 753 vaccine
network of alliances has emerged among global trials currently active
firms and a wide range of government and regional with 220 vaccine
commercial partners, and the Asia Pacific (APAC) candidates in 78
region is not an exception. countries.

As of July 20, 2022, the World Health

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“We are on track to “We built a manufacturing
fulfil our commitment infrastructure that has set
the stage for widespread
to deliver at least 2 distribution of NVX-CoV2373.
billion doses to low- Today, we are proud to be
and middle-income
countries in 2021 and delivering our COVID-19
2022, including at least vaccine across North America,
1 billion doses this year.”
Europe, Asia, Australia, and
- Dr Albert Bourla, Oceania.”
Chairman and Chief Executive Officer, Pfizer - Dr James F. Young,

“The data show Ph.D. Chairman of the Board of Directors Novavax
the ability of our
monovalent and bivalent Dodgy Omicron
Omicron-adapted
vaccine candidates to Several COVID-19 vaccine candidates currently
significantly improve in use target the receptor-binding domain (RBD)
variant-specific antibody of SARS-CoV2 spike proteins in order to elicit an
neutralisation responses.” immune response. In most cases, the new variants
of SARS-CoV2 like Delta and other evolving
- Prof. Ugur Sahin, sublineages of Omicron (BA.1. BA.2, BA.4, and BA.5)
M.D., CEO and Co-founder, BioNTech have outcompeted variants of SARS-CoV2 and its
evolving sublineages have outcompeted B.1.1 early
“In the second quarter, we variant by evading the immune response induced by
expect to have Omicron- the vaccines currently in use. A recent observation
indicates that Omicron now accounts for roughly 97
containing bivalent COVID per cent of infections globally, with BA.2 accounting
booster vaccine candidates for the greatest share (39 per cent) as a dominant
with robust Phase 3 pipeline sub-variant. Further, the Omicron variant of
leading to three respiratory COVID-19 is evolving into several more transmissible
commercial launches over variants that are rapidly gaining ground.
the next two to three years”.
“Altogether, multiscale investigations suggest
- Stephane Bancel, that the risk of [L452-bearing Omicron variants],
Chief Executive Officer, Moderna particularly BA.4 and BA.5, to global health is
potentially greater than that of original BA.2,” says
“We will play a role as a Kei Sato and colleagues at the University of Tokyo.
global vaccine hub as Another thing that’s concerning some scientists
an innovative vaccine/ is a mutation in the spike protein gene at position
LR452, which may make BA.4 and BA.5 (and related
bio partner based on the variants, including BA.2.12.1) more contagious than
cooperation with various earlier Omicron variants, as well as more prone to
global companies, as well infecting lung tissue.

as developing diverse Having identified these emerging pitfalls,
vaccines independently.” regulatory authorities worldwide have advised
vaccine companies to update their products with
- Jaeyong Ahn, an additional Omicron BA.4/5 component to create
CEO, SK bioscience bivalent booster vaccines. Companies are not being
asked to tweak their existing primary COVID-19
vaccines, as the regulator sees these as providing
a ‘base of protection’ against serious outcomes.
Nevertheless, biopharma companies and R&D
centres are now on their toes to catch the race to
compete with the virulence rate and regulatory

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“COVAXIN is a multi-epitope “Vaxzevria can help
vaccine with antibodies prevent Omicron-
against spike, RBD, and related infections when
N proteins. We have given as a fourth dose,
now achieved our goal with greater protection
of developing a safe and against infection than
was seen following a
efficacious vaccine with long-
term protection against a third dose.”
spectrum of variants.” - John Perez,
- Dr Krishna Ella,
Senior Vice President, Head of Late Development,
Chairman and Managing Director, Bharat Biotech Vaccines & Immune Therapies, AstraZeneca

pressure. neutralisation responses,” said Prof. Ugur Sahin,
Meanwhile, regulators at European Medicines M.D., CEO and Co-founder of BioNTech.

Agency (EMA) and the United States of America On July 8, 2022, COMIRNATY became the
(USA) Food and Drug Administration (FDA), and first and only COVID-19 vaccine to be granted
Asian regions are advising vaccine makers to update FDA approval for adolescents 12 years and older,
their booster shots for BA.4 and BA.5 variants following EUA in May 2021. Pfizer and BioNTech also
to remain vigilant. Companies are thoughtfully filed these data with the EMA and other regulatory
deploying capital in a variety of shareholder-friendly authorities worldwide.
ways with the goal of maximising the value for all
stakeholders, including patients. Here we discuss Pfizer reported strong financial results and
some of the vaccine candidates approved by the WHO revenue status for the first quarter of 2022, indicating
which are claiming promising results to meet global COMIRNATY revenues of approximately $32 billion,
expectations. which reflects anticipated operational increases
offset. This status includes doses expected to be
Comirnaty (BNT162b2_ mRNA vaccine) delivered in fiscal 2022 under contracts signed as of
mid-April 2022.
[Pfizer and BioNTech]
First-quarter 2022 operational growth was
COMIRNATY is developed by Pfizer using primarily driven by COMIRNATY globally, which
BioNTech’s proprietary mRNA technology platform grew from $10.2 billion operationally to $13.2 billion
with BioNTech being the marketing authorisation in direct sales and alliance revenues, driven by global
holder. In the APAC region, COMIRNATY has already uptake including paediatric and booster doses,
been deployed under EUA or equivalent regulatory following a growing number of regulatory approvals
approvals in most countries. and temporary authorisations.

On June 25, 2022, Pfizer and BioNTech Dr Bourla, stated, “We are on track to fulfil our
announced positive data evaluating the safety, commitment to deliver at least 2 billion doses to
tolerability, and immunogenicity of two Omicron- low- and middle-income countries in 2021 and 2022,
adapted COVID-19 vaccine candidates: one including at least 1 billion doses this year.”
monovalent and the other bivalent. Preliminary
laboratory studies demonstrate both Omicron- Meanwhile, for the financial year 2022, BioNTech
adapted candidates neutralise Omicron BA.4 and estimates COVID-19 vaccine revenues of $13.5 billion
BA.5 though to a lesser extent than they do for BA.1 to $17.5 billion. BioNTech holds 2.4 billion doses
of COVID-19 vaccine orders for delivery in 2022.
“Based on the data from the Phase 2/3 trial, we The company has initiated the expansion of Phase
have two very strong Omicron-adapted candidates 3 clinical trials to include Omicron-based vaccine
that elicit a substantially higher immune response candidates.
against Omicron than we’ve seen to date,” said Dr
Albert Bourla, Chairman and Chief Executive Officer, SPIKEVAX (mRNA-1273 vaccine) [Moderna]
Pfizer.
As of July 11, 2022, Moderna unveiled its data on
“The data show the ability of our monovalent its Omicron-containing bivalent booster candidate
and bivalent Omicron-adapted vaccine candidates mRNA-1273.214, stating that it can elicit neutralising
to significantly improve variant-specific antibody antibody responses 1.69 times higher than the current

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booster. Moderna announced new clinical data on its its total revenue of $6.1 billion for the first quarter of
bivalent Omicron (BA.1) booster candidate, mRNA- 2022, compared to $1.9 billion for the same period
1273.214, and completed regulatory submissions in in 2021. Product sales for the first quarter of 2022
the EU, UK, and Australia. were $5.9 billion from sales of the company’s COVID
vaccine, compared to $1.7 billion in the first quarter
Moderna, in its multiple Phase 2/3 studies of 2021. Similarly, the cost of sales was $1 billion, or
demonstrates superior breadth and durability of 17 per cent, of product sales for the first quarter of
the immune response following a bivalent booster. 2022, including third-party royalties of $207 million.
SPIKEVAX (mRNA-1273.214) is reportedly Thus, Moderna reported a Net Income of $3.7 billion
demonstrating significantly higher antibody titers for the first quarter of 2022, compared to $1.2 billion
against all tested variants, including Omicron BA.1 for the same period in 2021.
and BA.4/5 subvariants, ancestral virus, Alpha,
Beta, Delta, and Gamma compared to the currently Moderna’s 2022 Advanced Purchase Agreements
authorised booster (mRNA-1273). The company (APAs) for product sales are approximately $21
is simultaneously developing mRNA-1273.222, billion and the company believes that COVID market
a bivalent candidate based on BA.4/5, as per the dynamics will result in sales slightly larger in the
latest regulatory guidance. Both bivalent candidates second half of 2022 than in the first half.
contain 25 µg of the currently authorised booster
(mRNA-1273) and 25 µg of an Omicron subvariant. Furthermore, Moderna announced a strategic
partnership with the Australian Federal Government
Stephane Bancel, Chief Executive Officer of to establish a state-of-the-art, domestic mRNA
Moderna shared, “We are working with regulators vaccine manufacturing facility in Australia.
to advance two bivalent vaccine candidates, mRNA-
1273.214 and mRNA-1273.222, based on different Simultaneously, Moderna announced its Global
market preferences for Omicron subvariants, clinical Public Health Strategy through four new initiatives
data requirements”. aimed at advancing mRNA vaccines for the
prevention of infectious diseases, including a new
Sharing Moderna’s signed advanced purchase program, mRNA Access, that will allow researchers
agreements for 2022 of $21 billion in Q1 progress, to use Moderna’s mRNA technology to explore new
Bancel explains “In the second quarter, we expect to vaccines against emerging or neglected infectious
have Omicron-containing bivalent COVID booster disease.
vaccine candidates with robust Phase 3 pipeline
leading to three respiratory commercial launches GEMCOVAC-19_(mRNA vaccine) [Gennova
over the next two to three years”. Biopharmaceuticals]

The 2022 financial results at Moderna indicate India-based Gennova Biopharmaceuticals,
a subsidiary of Emcure Pharmaceuticals in
collaboration with HDT Bio Corp, has introduced its
mRNA vaccine GEMCOVAC-19 which has received
the EUA from the office of the Drugs Controller
General of India (DCGI). With this in June 2022,
GEMCOVAC-19 became the world’s third mRNA
vaccine and the first mRNA vaccine to be developed
in India, approved and available for administration.
GEMCOVAC-19 is a Lyophilised mRNA vaccine for
Injection.

Gennova Biopharmaceuticals aims to produce
around 40-50 lakhs doses per month, potentially
doubling this capacity quickly. Gennova aims at
providing sustainable access to low-and middle-
income countries around the world to the vaccine to
blunt the spread of pandemics.

VAXZEVRIA / COVISHIELD_(ChAdOx1-S
[Recombinant]) AstraZeneca (formerly known
as AZD1222)

According to new data from Thailand’s Chiang
Mai University, AstraZeneca’s Vaxzevria (ChAdOx1-S

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COVID-19 VACCINES WITH WHO EMERGENCY USE LISTING

Vaccine WHO EUL Approval by National Regulatory
Holder Company Authority (NRA) in Asia, FDA and EMA
COMIRNATY® (Date of EUL Recommendation)
mRNA Vaccine (nucleoside modified) BioNTech
Approved in 146 countries Manufacturing GmbH European Medicines Agency (31 December 2020)
85 trials in 27 countries AstraZeneca AB / SK
Bioscience Co. Ltd Food and Drug Administration
VAXZEVRIA AstraZeneca AB (16 July 2021)
(ChAdOx1-S [recombinant])
Approved in 141 countries Oxford/AstraZeneca Ministry of Food and Drug Safety (MFDS) - Korea
66 trials in 31 countries (15 February 2021)
Serum Institute
COVISHIELD™ of India Pvt. Ltd European Medicines Agency
(ChAdOx1-S [recombinant]) (15 April 2021)
Approved in 49 countries Janssen–
4 trials in 1 country Cilag International NV Ministry of Health, Labour & Welfare MHLW - Japan
Novavax CZ a.s. (09 July 2021)
Ad26.COV2-S [recombinant]
Approved in 111 countries Moderna Biotech Therapeutic Goods Administration Australia
24 trials in 24 countries (09 July 2021)
ModernaTX, Inc
SPIKEVAX Central Drugs Standard Control
mRNA Vaccine (nucleoside modified) Beijing Institute of Organization- India
Approved in 86 countries; Biological Products Co., (15 February 2021)
67 trials in 23 countries Ltd. (BIBP)_Sinopharm
European Medicines Agency
COVILO, Inactivated Vaccine (12 March 2021)
BBIBP-CorV (Vero Cells)
Approved in 91 countries European Medicines Agency
31 trials in 13 countries (30 April 2021)

CORONAVAC, Inactivated Ministry of Food and Drug Safety (MFDS) -Korea
(Vero Cell) Vaccine (23 December 2021)
Approved in 56 countries
39 trials in 10 countries Food and Drug Administration
(06 August 2021)
COVAXIN®
(Whole Virion Inactivated vaccine) National Medicinal Products
Approved in 14 countries Administration (NMPA)-China
14 trials in 2 countries (07 May 2021)

COVOVAX™ Sinovac Life National Medicinal Products
(SARS-CoV-2 rS Protein Sciences Co., Ltd Administration (NMPA) -China
Nanoparticle [Recombinant]) (01 June 2021)
Approved in 5 countries; Bharat Biotech
Under 4 trials in 2 countries International Ltd Central Drugs Standard Control
Organisation -India
NUVAXOVID™ (03 November 2021)
(SARS-CoV-2 rS [Recombinant, Under suspension of supply
adjuvanted])
Approved in 39 countries; Serum Institute Central Drugs Standard Control
Under 17 trials in 13 countries of India Pvt. Ltd Organisation -India
(17 December 2021)
CONVIDECIA
(Ad5.CoV2-S [Recombinant]) Novavax CZ a.s. European Medicines Agency
Approved in 10 countries (20 December 2021)
13 trials in 6 countries
CanSino Biologics Inc. National Medical Products
Administration (NMPA) - China
(19 May 2022)

Source: Compiled using “COVID-19 Vaccine Tracker” and WHO data

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GLOBAL STATUS OF COVID-19 VACCINE TRIAL AS OF 20 JULY 2022

STATUS OF VACCINE APPROVALS IN ASIA-PACIFIC REGION

Country Number of vaccines approved Country Number of vaccines approved
(Data as of 20 July 2022) (Data as of 20 July 2022)

AUSTRALIA  Comirnaty (Pfizer/BioNTech) JAPAN  TAK-019
Approved: 5  Spikevax (Moderna) Approved: 4
Under Clinical  Vaxzevria (Oxford/AstraZeneca) Under Clinical (Novavax formulation by Takeda)
Trial: 20  Nuvaxovid (Novavax) Trial: 14  Comirnaty (Pfizer/BioNTech)
 Ad26.COV2.S (Janssen-  TAK-919

Johnson & Johnson) (Moderna formulation by Takeda)
 Vaxzevria (Oxford/AstraZeneca)

CHINA  Convidecia (CanSino) MALAYSIA  Spikevax (Moderna)
Approved: 6  CoronaVac (Sinovac) Approved: 8  Comirnaty (Pfizer/BioNTech)
Under Clinical  Covilo (Sinopharm_Beijing) Under Clinical  Convidecia (CanSino)
Trial: 31  Inactivated_Vero Cells (Sinopharm_ Trial: 2  Ad26.COV2.S (Janssen -
Wuhan)
HONG KONG  Zifivax (Anhui Zhifei Longcom) Johnson & Johnson)
Approved: 2  KCONVAC (Shenzhen  Vaxzevria (Oxford/AstraZeneca)
Under Clinical Kangtai Biological Products Co)  Covaxin (Bharat Biotech)
Trial: 6  Covilo (Sinopharm_Beijing)
 Comirnaty (Pfizer/BioNTech)  CoronaVac (Sinovac)
INDIA  CoronaVac (Sinovac)
Approved: 11 NEW ZEALAND  Nuvaxovid (Novavax)
Under Clinical  Covishield (Oxford/ AstraZeneca Approved: 4  Comirnaty (Pfizer/BioNTech)
Trial: 16 formulation by Serum Institute of India) Under Clinical  Ad26.COV2.S (Janssen_
 Covaxin (Bharat Biotech) Trial: 7
INDONESIA  Corbevax (Biological E Limited) Johnson & Johnson)
Approved: 11  COVOVAX (Novavax formulation  Vaxzevria (Oxford/AstraZeneca)
Under Clinical by Serum Institute of India)
Trial: 16  ZyCoV-D (Zydus Cadila) SOUTH KOREA  Nuvaxovid (Novavax)
 GEMCOVAC-19 (Gennova Approved: 6  SKYCovione (SK Bioscience Co Ltd)
Biopharmaceuticals Limited) Under Clinical  Spikevax (Moderna)
 Spikevax (Moderna) Trial: 9  Comirnaty (Pfizer/BioNTech)
 Sputnik Light (Gamaleya)  Ad26.COV2.S (Janssen_
 Sputnik V (Gamaleya)
 Ad26.COV2.S (Janssen by Johnson & Johnson)
Johnson & Johnson)  Vaxzevria (Oxford/AstraZeneca)
 Vaxzevria (Oxford/AstraZeneca)
SINGAPORE  Comirnaty (Pfizer/BioNTech)
 Zifivax (Anhui Zhifei Longcom) Approved: 4  Spikevax (Moderna )
 COVOVAX (Novavax formulation Under Clinical  CoronaVac (Sinovac)
by Serum Institute of India) Trial: 5  Nuvaxovid (Novavax)
 Spikevax (Moderna)
 Comirnaty (Pfizer/BioNTech) TAIWAN  Spikevax (Moderna)
 Convidecia (CanSino) Approved: 5  Comirnaty (Pfizer/BioNTech)
 Sputnik V (Gamaleya) Under Clinical  Vaxzevria (Oxford/AstraZeneca)
 Ad26.COV2.S (Janssen - Trial: 7  Nuvaxovid (Novavax)
Johnson & Johnson)  MVC-COV1901 (Medigen)
 Vaxzevria (Oxford/AstraZeneca)
 KCONVAC (Shenzhen THAILAND  COVOVAX (Novavax formulation
Kangtai Biological Products Co) Approved: 7
 Covilo (Sinopharm -Beijing) Under Clinical by Serum Institute of India)
 CoronaVac (Sinovac) Trial: 12  Spikevax (Moderna)
 Comirnaty (Pfizer/BioNTech)
 Ad26.COV2.S (Janssen_

Johnson & Johnson)
 Vaxzevria (Oxford/AstraZeneca)
 Covilo (Sinopharm_Beijing)
 CoronaVac (Sinovac)

Source: Compilation with reference to “COVID-19 Vaccine Tracker” and respective company sites

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[Recombinant]) ‘viral vector’ vaccine is proven to be candidate developed using a proprietary recombinant
effective against the Omicron variant when used as a technology platform harnessing highly immunogenic
fourth dose booster. Based on the data, John Perez, nanoparticles in the form of the NVX-CoV2373
Senior Vice President, Head of Late Development, COVID-19 vaccine. Novavax’s recombinant protein
Vaccines & Immune Therapies, AstraZeneca, said, nanoparticle COVID-19 vaccine uses Matrix-M as an
“Vaxzevria can help prevent Omicron-related adjuvant. Serum Institute of India Pvt. Ltd. markets
infections when given as a fourth dose, with greater NVX-CoV2373 under the brand name Covovax SARS-
protection against infection than was seen following a CoV-2 rS Protein Nanoparticle [Recombinant]).
third dose.” Covovax has received EUL from the WHO, as well as
EUA in India, Indonesia, the Philippines, Thailand,
Vaxzevria has been granted a conditional and Bangladesh.
marketing authorisation or emergency use in more
than 125 countries. It also has EUL from the WHO, However, in Europe and non-APAC markets
which accelerates the pathway to access in up to 144 the vaccine is marketed by Novavax with the trade
countries through the COVAX Facility. Under a sub- name Nuvaxovid COVID-19 Vaccine (SARS-CoV-2
license agreement with AstraZeneca, the vaccine is rS [Recombinant, adjuvanted]). Nuvaxovid is
manufactured and supplied by the Serum Institute of approved in 39 countries and undergoing 17 trials
India under the trade name COVISHIELD. in 13 countries as stated by WHO. Novavax and SII
have committed a cumulative 1.1 billion doses of the
Sharing the Q4 (fourth quarter) 2021 financial Novavax vaccine to COVAX.
reports the company noted that it has delivered
approximately 102 million doses of its COVID-19 On July 13, 2022 Novavax announced that the
vaccine through COVAX. As of the end of December Novavax COVID-19 Vaccine, Adjuvanted (NVX-
2021, the company and its sublicensee Serum CoV2373) has received EUA from the US FDA
Institute of India Pvt. Ltd. (SII) has delivered more to provide a two-dose primary series for active
than 247 million doses with COVAX to 130 countries. immunisation. Novavax already has BA.1 and BA.4
As of February 2022, AstraZeneca and SII remain the and BA.5 monovalent vaccines in development, with
largest contributor to COVAX and have released more results expected in Q3 and Q4 2022.
than 2.8 billion vaccine doses to over 180 countries,
two-thirds of which are in low- and middle-income “We built a manufacturing infrastructure that has
countries. set the stage for widespread distribution of NVX-
CoV2373. Today, we are proud to be delivering our
Further, in its Q1 2022 financial statements COVID-19 vaccine across North America, Europe,
released on April 29, 2022, the company indicates Asia, Australia, and Oceania” Dr James F. Young,
its financial performance (growth numbers at CER) Ph.D. Chairman of the Board of Directors Novavax.
with an increase in Total Revenue by 60 per cent
to $11,390 million, reflecting growth across the COVAXIN_(whole-virion inactivated vaccine)
company, including several Vaxzevria contracts
that are expected to complete the delivery by half [Bharat Biotech]
year 2022. In its Q4 2021 financial statements,
AstraZeneca indicates Total Revenue increased by COVAXIN, India’s indigenous COVID-19 vaccine,
41 per cent (38 per cent at CER1) to $37,417 million a whole-virion inactivated COVID-19 vaccine
including COVID-19 vaccine revenues. candidate by Bharat Biotech is developed using a
Whole-Virion Inactivated Vero Cell-derived platform
The majority of Vaxzevria revenue in 2022 is technology, in collaboration with the Indian Council
expected to come from initial contracts. Thereafter, of Medical Research (ICMR) - National Institute of
AstraZeneca expects a decline in its COVID-19 Virology (NIV).
vaccine revenues due to a projected decline in
Vaxzevria sales partially offset by an increase in its On July 20, 2022, the company indicated that
Evusheld COVID-19 medicine sales. COVAXIN demonstrated persistent immunogenicity
against spike protein, N protein, and neutralising
Meanwhile, on January 13, 2022, the company antibody responses against emerging variants (Alpha,
announced that COVISHIELD as the third dose of Beta, Delta, Delta Plus, and Omicron) and showed
booster vaccine is found to be effective against Beta, increased memory B cell response. On April 26,
Delta, Alpha, and Gamma strains of SARS-CoV 2. 2022, BBV152 (COVAXIN) received emergency use
approval in children 6-12 years.
COVOVAX / Nuvaxovid (NVX-CoV2373
Dr Krishna Ella, Chairman and Managing
protein-based vaccine)_Novavax Director, Bharat Biotech, said, “COVAXIN is a multi-
epitope vaccine with antibodies against spike, RBD,
NVX-CoV2373 is a protein-based vaccine and N proteins. A post booster dose has proven to

28 COVER STORY

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APPROVED ASIAN INDIGENOUS VACCINES

Global shortages of COVID-19 vaccines have sparked SK Bioscience reported record high revenues of KRW 929
the race to develop home-grown versions. Developing a billion ($763.8 million) in 2021, up from just KRW 225.6
domestic COVID-19 vaccine will accelerate the country’s billion earlier, boosted by the vaccine manufacturing
vaccine sovereignty and reduce its dependence on agreements.
vaccine imports. India and China own maximum ventures
in this dimension to meet the demand and supply of  MVC-COV1901: Taiwan’s Medigen Vaccine
COVID vaccines for its billion population. Biologics Corporation in association with American
company Dynavax Technologies, and the U.S. National
 COVAXIN, India’s first indigenous COVID-19 vaccine, Institutes of Health has developed MVC-COV1901
a whole-virion inactivated COVID-19 vaccine candidate by (MVC COVID-19 vaccine). This vaccine is made by the
Bharat Biotech. recombinant S-2P spike protein coupled with Dynavax
CpG 1018 adjuvant. On July 19, 2021, the MVC COVID-19
 Corbevax: India-based biopharma firm Biological E. vaccine obtained EUA approval in Taiwan.
Limited (BioE) has been licensed to develop and produce
CORBEVAX, the first vaccine in India to be approved  Zifivax (ZF-UZ-VAC-2001), is an adjuvanted
as a heterologous COVID-19 booster shot. Corbevax, a protein subunit COVID-19 vaccine developed by Chinese
protein subunit COVID-19 vaccine consists of SARS‑CoV‑2 firm Anhui Zhifei Longcom in collaboration with the
receptor binding domain (RBD) spike protein, adjuvanted Institute of Microbiology at the Chinese Academy of
with aluminum hydroxide gel, and CpG 1018. It was Sciences. Zifivax is approved for Emergency use in China,
developed by the Texas Children’s Hospital Center for Colombia, Indonesia, Pakistan, and Uzbekistan.
Vaccine Development and Baylor College of Medicine
in Houston, Texas, and Dynavax technologies based in  KCONVAC: Minhai COVID-19 vaccine trademarked
California. The U.S. International Development Finance as KCONVAC developed by Shenzhen Kangtai Biological
Corporation (DFC) to fund the expansion of Biological E’s Products Co. Ltd and its subsidiary, Beijing Minhai
manufacturing capabilities allowing the production of at Biotechnology Co., Ltd. On May 14, 2021, the vaccine
least 1 billion doses by the end of 2022. Since the vaccine became the fourth inactivated Chinese vaccine to
is intended for low-income countries, it is designed to be be authorised for emergency use. This vaccine also
easily stored and manufactured. The vaccine technology is referred to as SARS-CoV-2 Vaccine (Vero Cells),
is given patent-free to manufacturers and is planned to be KconecaVac.
openly licensed under COVAX.
 Convidecia (CanSino): Chinese firm CanSino
 ZyCoV-D: India- based pharmaceutical company Biologics developed AD5-nCOV, trade-named Convidecia, a
Zydus Lifesciences Limited developed ZyCoV-D a DNA single-dose viral vector vaccine for COVID-19. On May 19
plasmid-based COVID-19 vaccine. On August 20, 2021, 2022, WHO issued EUL for the vaccine.
it received approval for emergency use in India. On April
23, 2021, production of the ZyCoV-D vaccine was started,  CoronaVac: Sinovac COVID-19 vaccine (CoronaVac),
with a yearly capacity of 240 million doses. The interim is a whole inactivated virus COVID-19 vaccine developed
analysis of the ZyCoV-D vaccine indicates efficacy, safety, by the Chinese company Sinovac Biotech.
and immunogenicity in its phase 3 trial.
 COVILO: Beijing-based firm (Sinopharm developed
 SKYCovione: South Korea’s SK Bioscience and COVILO, a formulation of the SARS-CoV-2 strain which is
the Institute for Protein Design (IPD) at the University of inoculated on the Vero cells for culturing.
Washington, have developed the SKYCovione vaccine by
utilising GSK’s AS03 adjuvant technology. On June 29,  Inactivated_Vero Cells: Wuhan-based Sinopharm
2022, SKYCovione was authorised by the Korean Ministry has developed a vaccine by inoculating Vero Cell with
of Food and Drug Safety (KMFDS) for use in South Korea. Inactivated SARS-CoV-2, 19nCoV-CDC-Tan-HB02 strain,
to harvest β-propiolactone-inactivation which is extracted
using aluminium hydroxide adjuvant to form the liquid
vaccine.

neutralise antibody responses against variants of along with knowledge sharing which is expected to
concern and long-term protection through memory T enhance mass production without any compensation
and B cell responses. We have now achieved our goal to the original developer. Many predict that this
of developing a safe and efficacious vaccine with long- would have massive consequences for the expected
term protection against a spectrum of variants.” return on investment of life sciences companies
developing these products. International experts
Future trends opine that the waiver will harm innovation and
may lead to the overproduction of vaccines and
In June 2022, the World Trade Organisation wastage of formulation components. There is a need
(WTO) adopted a waiver of the Agreement on to accelerate research and development into next-
Trade-Related Aspects of IP Rights (TRIPS generation vaccines, tests, and treatments from all
Agreement) for COVID-19-related vaccines and stakeholders.
pharmaceuticals. With the waiving of the TRIPS
Agreement, many governments hope to benefit Hithaishi C Bhaskar
from obtaining a vaccine platform and formulation, [email protected]

CDMOs 29

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How CDMOs are Adapting
to New mRNA Tech Demands

From 2020, coinciding with the outbreak of COVID-19, there’s been a steady upsurge in demand
for new technologies such as messenger RNA (mRNA). Contract development and manufacturing
organisations (CDMOs) are compelled to rapidly expand capabilities to cater to this upsurge.
Let’s see how CDMOs have prepared for the new wave of technologies on the horizon, and the
challenges they faced in welcoming a new era of such technologies.

The COVID-19 pandemic highlighted the Weathering the storm
successful development and utilisation
of mRNA vaccines. This has encouraged Even though COVID-19 fuelled the growth for
biopharmaceutical companies to explore and the CDMO market, it also brought its fair share of
utilise these technologies for other diseases. challenges.
There are a significant number of new
therapeutic programmes that are based on Managing supply chains was perhaps the
mRNA and lipids, which is encouraging CDMOs biggest challenge as the pandemic had a sudden
to invest in new expertise to deliver end-to-end and extreme impact on the supplier / distributor
solutions. network.

CDMOs have been building new capacity, “This challenge demanded the fast, yet precise,
while simultaneously building out capabilities, to expansion of clinical supply
better prepare for the new wave of technologies. chains, which would need to be
Many CDMOs have invested in new processes informed by data and expertise
and resources to safeguard product integrity, and underpinned by a global
minimise waste, enable safe and efficacious infrastructure and network,”
supply to patients without delay. said Kevin Cheong, Director,
Clinical Operations-Asia,
“In the area of mRNA technology, we have Almac Clinical Services,
seen CDMOs do almost exclusive internal builds, UK. Kevin is based in
while others are making strategic acquisitions to Singapore.
develop their mRNA capabilities. Many CDMOs,
like the Center for Breakthrough Medicines, As mRNA-based technology is a newer modality
are expanding to include this dedicated and in the industry, few CDMOs have the extensive
segregated capacity. It is extraordinarily complex experience and a historical track record to point
and a different process from other processes to. However, CDMOs with teams of scientists that
CDMOs are currently running, have the expertise in the area could mediate the
so you must make sure to challenges and address the growing mRNA market
segregate these operations as much more quickly.
much as possible from your
existing manufacturing,” said “mRNA-based technology challenges are not
Joerg Ahlgrimm, President necessarily unique. All cell and gene manufacturing
and CEO, Center for technologies have faced obstacles that needed to
Breakthrough Medicines, be overcome. That said, for mRNA I see these two
US. challenges. The first is building or acquiring the
capacity to scale up manufacturing, as well as being
With mRNA-based drugs able to source high quality mRNA synthesis. The
witnessing a surge in popularity in such a other is mastering and being able to replicate the
short time frame, companies supporting their technology process, which is a key element to being
development and manufacturing had to adapt a successful CDMO,” said Joerg.
quickly as mRNA- based vaccines required cold
chain capabilities and more robust aseptic fill- During the pandemic, production capacity and
finish technologies. yields had to be dramatically increased, which came
with obvious challenges.

“Capacity is another hurdle for DNA and plasmid
production, a process that uses fermentation

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alongside E. coli. Suite dedication is a key issue as experience with COVID-19 vaccines. It is clear
carrying out a fermentation process in a suite that that both innovator companies and CDMOs, with
also runs a mammalian cell culture would lead to a the right amount of public support, can develop
risk of cross-contamination. As a a product and bring it to market extremely
result, alternative manufacturing quickly. That said, all the stars were aligned. Every
platforms such as synthetic government and health agency wanted a rapid-fire
plasmid DNA (doggy bone) solution - a product that worked and worked safely,
may grow in prominence,” so the normal barriers to fast track a product to
said Lawrence Yap, market were eliminated,” said Joerg.
Global Head, Technical
Operations, Hilleman Another important lesson is to have robust
Laboratories, Singapore. supply chain management processes in place.

The unique nature of “One of the lessons learnt is in supply chain
mRNA also creates analytical challenges in drug management to avoid disruptions. Manufacturers
development. It is important to remember that should ensure that there is always a reliable supply
mRNA technology itself is advancing rapidly of raw materials and consumables. At the same
and evolving on a continual basis. Developers of time, we need to identify potential sources of
analytical methods for mRNA therapeutics and equipment and consumables as alternative options
vaccines are therefore challenged not only by in the event of delays from their primary source,”
the complexity of these biomolecules and their said Lawrence.
delivery vehicles, but also by the need to develop
flexible methods that can accommodate the Contract manufacturers are now evolving
ongoing changes in mRNA structures and final into the space of Contract Research and
formulations. Manufacturing Services (CRAMS), becoming
valued partners to pharma players in every sense
“There is also the analytical challenge to of the word.
identify appropriate tests that can monitor the
quality of each intermediate. This requires highly “The model involves working with Contract
specialised assays and analytical testing to properly Research Organisations (CROs) to generate data
characterise the molecule, and select the most supporting the pathway to enter into the clinic,
appropriate formulation, which may include lipid followed by partnering with an innovator to provide
nanoparticle manufacturing,” added Lawrence. the resources for subsequent drug development.
The small biotech-innovator
Shortage of skilled workforce is another relationship will ideally turn
bottleneck. CDMOs need highly technically skilled into a tripartite agreement
talents to develop, produce, and test each mRNA- where the execution component
based entity. continues to come from an
integrated service provider
“It has been challenging to find talents who (CRO-CDMO) with end-to-end
can support the rapid build-out in manufacturing, capabilities,” said Dr Mahesh
analytics, manufacturing science and technology Bhalgat, COO, Syngene
(MST), tech transfer and chemistry, and International, India.
manufacturing and controls (CMC). We are seeing
a growing demand for talents who have skill sets Much of what CDMO could achieve during this
and deep knowledge in microbial fermentation and crisis is also because of technology and digitisation
also the biocatalytic enzymatic synthesis process,” of the development and manufacturing process,
said Lawrence. and moving forward technology will play an even
more important role in the functioning of the
Lessons learned CDMOs.

The pandemic and the resulting fast approval The challenges faced by the sector throughout
of vaccines has highlighted the ability of the the pandemic highlighted how important it is to
industry to move much more quickly through the be nimble and flexible to ensure consistent and
drug development process than was ever thought cost-effective delivery. CDMOs that demonstrated
possible. It also shows the importance and power of agility and ability to respond to the shift in market
strategic collaborations. dynamics, as well as adapt their manufacturing
capabilities for new technologies, are best suited for
“One of the most important lessons we learnt the future.
about preparing for the future stems from our
Ayesha Siddiqui

PHARMA 4.0 31

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IS INDUSTRY 4.0
PROMISING THE MOON?

As pharma grapples with rising complexity, costs and regulation, the sector is looking to industry
4.0 manufacturing as a solution. Smart factories managed with next generation technologies will
lower pharma manufacturing costs, improve quality and reduce capacity constraints. Let’s look at
how pharma is adopting industry 4.0.

As pharma shifts from generic drugs to Adoption of pharma 4.0
personalised medicines, it has become
apparent that conventional systems lack the The pharma industry has been relatively slow
capabilities to keep up with complex manufacturing to embrace concepts such as Industry 4.0, but
processes. Traditional manufacturing technology COVID-19 is serving as a catalyst for sweeping
was built for large-scale, standardised drug batches. changes within the industry. Industry’s regulated
That’s why the industry is turning to much faster and nature, high cost, manufacturing complexity are
more agile solutions. They’re leveraging the predictive some of the reasons the industry is lagging in
capabilities of artificial intelligence (AI) and machine establishing smart factories.
learning (ML) to build smarter, more secure, and
future-ready manufacturing centres. Redesigning “I guess this is still a very novel concept for the
the traditional Good Manufacturing Practice (GMP) industry. The capabilities of vendors and service
cleanroom to accommodate closed and automated providers are evolving. The existing manufacturing
processes is a necessary step toward improving the set up needs to be revamped completely to
cost and quality of tomorrow’s medicines. accommodate such future ready systems. The talent
is also limited in the market who can deploy 4.0
In a smart factory, machines autonomously
run entire production processes. Technologies “Manufacturers are realising
like robotics, data analytics, distributed ledgers, the potential of data
vision systems, augmented reality, virtual reality,
artificial intelligence (AI), and the Internet of analytics to understand
Things (IoT), digital twin, come together to connect the current performance of
different operations, respond to new situations,
and adapt as a result of those responses. As lean their production lines and
manufacturing, alternative sourcing, and other mitigate the risk of downtime
traditional improvement levers mature, the smart
factory is set to bring the next dramatic shift in with investments in data
manufacturing efficiencies. The increasing number analytics to provide predictive
and variety of therapies, as well as the increased maintenance and condition-
number of fast-track review paths, means CMC
(chemistry, manufacturing and control) activities based monitoring.”
have become more important in ensuring speed to - Michael Larner,
market. Digitalisation and automation can also be
seen to allow scalability for a range of manufacturing Research Director, ABI Research, UK
processes, including cell and gene therapies.
“ The capabilities of vendors
“Manufacturers are seeing the potential of data and service providers are
analytics to understand the current performance evolving. The existing
of their production lines and mitigate the risk of
downtime with investments in data analytics to manufacturing set up needs
provide predictive maintenance and condition-based to be revamped completely to
monitoring,” said Michael Larner, Research Director,
ABI Research, UK. accommodate future ready
systems. The talent is also
limited in the market.”
- Aditya Sharma,
Head, Bioprocessing, Merck Life Science India

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Industry 4.0 meets pharma manufacturing processes and manage such facilities.
It needs significant investments and until the
● In 2022, Triastek’s and Siemens China signed payouts are clearly defined, industry will hesitate to
a collaboration agreement to provide digital get into this direction. It also needs a change in the
technologies for the global pharmaceutical mindset to allow the machines and software to run
industry. Combining Triastek’s 3D printing processes with lesser human control or intervention.
and digital pharmaceutical technologies It will take some time,” said Aditya Sharma, Head –
and Siemens’ expertise in automation Bioprocessing, Merck Life Science India.
and digitisation is expected to lead to
innovative and transformative solutions Pharmaceutical firms persist with paper
for the development and manufacturing of processes – there is inertia to change current
pharmaceuticals practices. In some cases, it’s a reflection of an
adversarial relationship with regulators and wanting
● In 2022, Singapore’s MiRXES opened to hinder regulators’ ability to locate procedural
Southeast Asia’s first industry 4.0 IVD (in information.
vitro diagnostics) manufacturing facility in
Singapore “In addition, there aren’t enough individuals
with the required skills in analytics and artificial
● In 2021, UK’s GlaxoSmithKline is one of the intelligence entering the pharmaceutical labour
first pharmaceutical companies to announce force. I expect this will change in due course as the
a digital twin initiative. Partnering with role of vaccine production to tackle outbreaks of
Siemens and Atos, GSK has created a real-time diseases has raised the perception of the industry.
simulation of the entire vaccine manufacturing But historically the pharma industry has struggled
process to compete with retail, banking, and consumer
goods manufacturers for digital talent,” said
● In 2021, Boehringer Ingelheim announced it Michael.
is rolling out cutting-edge tech at the Vienna
plant, from virtual reality and automation to Regulatory agencies including the U.S. FDA
digital twins and artificial intelligence. (Food and Drug Administration), EMA (European
Medicines Agency), and China’s NMPA (National
● In 2020, US’ Merck teamed up with Siemens to Medical Products Administration) have encouraged
digitise its manufacturing processes with the pharmaceutical companies to modernise their
objective to automate its modular production manufacturing processes.
and advance pharma’s 4.0 movement
The USFDA has dedicated significant effort
● In 2019, India based ACG Group opened over the past several years in establishing both
industry 4.0 centre of excellence in Switzerland research and regulatory programmes for advanced
manufacturing, computational modelling, and
Digital Plant Maturity Model other emerging technologies. These efforts have
led to updated regulatory processes, guidance
The Digital Plant Maturity Model (DPMM) documents and dozens of peer-reviewed research
categorises plants based on their level of publications to identify characteristics of advanced
digitalisation, automation, and data integration manufacturing processes that can provide regulatory
between teams. Pre-digital plants (Level 1) evidence of quality, safety and efficacy. The FDA
use manual and paper-based processes, while also encourages use of advanced manufacturing
adaptive plants (Level 5) are fully autonomous through involvement in new standards development
and self-optimising. According to Our Horizons: and industry outreach.
Life Sciences report 2021 by CRB Group, slightly
more than half of all respondents in their survey “As industry moves towards AI, deep learning,
said their company is at DPMM Level 3. “This machine learning and self-improving manufacturing
aligns with what we see from our own clients over systems, regulations will play a crucial role. The
the past three years, most of whom are at either key challenges would be – how to regulate and
Level 2 or 3. However, large biopharma companies monitor such self-controlling and self-managed
skew toward Level 4 (61 per cent), while systems. Human intervention will keep reducing
significantly fewer start-ups and CMOs (contract and the whole digitalisation/automation of the
manufacturing organisations) have achieved this manufacturing processes will increase. The need
level of digitalisation,” the report noted. to find a balance between the two will be extremely
critical,” said Aditya.

Ayesha Siddiqui

DRONES 33

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Providing Succour By UAVs

Drone technology has ceased to be just a mere fanciful and impractical aspect of Hollywood
blockbusters, making headway into almost every aspect of modern industries and services.
Naturally, healthcare isn’t far behind in leveraging this nifty and reliable tech to its advantage. Let’s
see how deep has been the penetration of this aerial supply chain wonder gadget.

Drones also referred to as unmanned aerial APAC and global drone market
vehicles (UAV), are slowly making their
presence felt in the healthcare sector. Gone According to Fortune Business Insight, the
are the days when sending emergency life-saving global commercial drone market size was valued
medicines to the remotest part of the country was at $6.51 billion in 2021. The market is projected to
unthinkable and would take days to reach. grow from $8.15 billion in 2022 to $47.38 billion
by 2029, exhibiting a CAGR of 28.58 per cent
With the advent of drone technology and during the forecast period. The market in the Asia
healthcare and medtech companies adopting it in a Pacific is predicted to display sudden growth, owing
new way plus the government’s push, has opened a to increasing drone production and operation
new era for drones in the health sector. corporations across the region, as per the report.

The usage of drones in the healthcare industry China became the global hub for drone industry
is becoming a new norm that is set to bring in a manufacturing over the past six years. About 70 per
revolution in the sector. The drone technology in cent of the world’s civilian drone market is supported
healthcare, previously envisioned for aerial and by China, with about 1200 drone manufacturers in
military use, is touted to become the future of 2019 (up from 130 manufacturers in 2013), as per a
healthcare. With the advent of drones, it is possible report by Research and Market. Various subsidies
to deliver blood, vaccines, birth control, snake bite and schemes are being provided by the Chinese
serum and other medical supplies to rural areas, Government. Besides, favourable domestic policies
where it can reach the victims who require immediate for drone purchases to promote technological
medical attention within minutes. The need for advancements in industrial sectors are some of the
drones was more relevant when COVID-19 vaccines welcome moves. Some of the prominent players
were transported to remote corners during the in the market are SZ DJI Technology Co (DJI),
pandemic. Hubsan, Terra Drone Corporation, Guangzhou
EHang Intelligent Technology Co, Yuneec and
According to Rashmi Pimpale, CEO, MicroMultiCopter Aero Technology Co etc. The
Research and Innovation Circle of country has recently launched a drone carrier with
Hyderabad (RICH), a one-of-a-kind artificial intelligence system that
many countries have includes dozens of autonomous drones, ships, and
recognised
the potential submersibles for
and have marine research
already begun and observation.
implementing
drone technology Melbourne-
in the healthcare based drone
space. For instance, logistics company
Rescue Robotics, Swoop Aero over the last
a mission to two years has been
deliver medical delivering medical
supplies to remote areas supplies through
in Rwanda and Ghana, drones across Malawi,
and the Maryland kidney the Democratic Republic of
delivery for transplant were the Congo, Mozambique, and
successful missions proving the Vanuatu in Africa. Recently the
usefulness of drones. company completed a $16 million
Series B venture capital raise. In March

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“The need for drones is “Across Asia Pacific,
much more in India than drone usage is gaining

in other places. A major traction in line with
challenge to the application that of India. Countries

of drone technology in the including Singapore,
healthcare space would South Korea (which are
come concerning the amongst the developed
nations in APAC) as well
regulatory infrastructure.
The government must get as Malaysia, Indonesia
(amongst the emerging/
all stakeholders together developing nations), have
and build the required built stringent drone laws
for the commercial-scale
infrastructure for smooth usage of these machines.”
operations of drone
- Aarti Chitale,
technology for healthcare.” Senior Industry Analyst,
- Dr Neeraj Sood, Healthcare & Lifesciences, Frost & Sullivan

Professor and Vice Dean- Research, University of
Southern California Price School of Public Policy

“Rules and regulations undertaken in the recent past.
need to be up to date Malaysia deployed drones to sanitise outdoor

with technology. public spaces. Drones carried out large-scale misting
If we don’t have of areas with disinfectants. The health ministry
forward-looking also used drones to transport COVID-19 vaccines
policies, we cannot and medical supplies to remote areas. Malaysia
implement drone tech Digital Economy Corporation (MDEC) has taken
on the task of leading the country’s drone industry.
successfully.” Recently SME Corporation Malaysia and MDEC
- Gopi Ganesalingam, have embarked on an initiative to scale drone tech
adoption in the health industry.
Chief Digital Industry Officer,
Malaysia Digital Economy Corporation (MDEC) Says Gopi Ganesalingam, Chief Digital Industry
Officer, MDEC, “Rules and regulations need to be up
and April 2022, polio vaccines were distributed via to date with technology. If we don’t have forward-
drones. looking policies, we cannot implement drone tech
successfully.”
Australia’s Civil Aviation Safety Authority (CASA)
has also granted Swoop Aero BVLOS (Beyond India-based drone startup Garuda Aerospace
Visual Line Of Sight) approval for medical logistics has teamed up with Malaysia-based HiiLSE Global
operations in Queensland. The company will be (HiiLSE Drones) to set up a 2.42 hectares drone
able to operate in a fully integrated airspace with factory in Malaysia with an investment of Rs 115
an aerodrome based hub at the local airport in crore. The company manufactures 30 different types
Goondiwindi. of drones and offers over 50 types of services which
includes drone delivery of medicines for hospitals
Japan-based Toyota Tsusho Corporation and US- and drone delivery of packages for food.
based Zipline initiated the launch of an automated,
on-demand delivery service for the distribution of A group of drone enthusiasts in Indonesia used
medical supplies across Japan’s Gotō Islands of their aerial skills to provide contactless medicine and
Nagasaki Prefecture. There were plans for regular food delivery to COVID-19 patients isolated at home.
flights to Naru Island, with plans to gradually As Indonesia is geographically spread out across
increase it to western Fukue Island, other islands in thousands of islands, the ‘Makassar Recover Drone
the city, Shinkamigoto and other areas. Medic’ team worked with the local coronavirus task
force to deliver medicines at least five times a day.
The South-East Asian countries fared better It was reported that during the peak covid outbreak
compared to India when it came to implementing around 25 rounds of deliveries were made in one day.
drones, especially in the backdrop of the COVID-19
pandemic. Let us look into some of the drone Singapore’s first drone delivery service started
initiatives which the South East Asian countries have with the first parcel containing 2 kg of vitamins

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“Many countries have partnered with Walmart to trial the small-scale
recognised the potential delivery of non-prescription drugs in Pea Ridge,
and have already begun Arkansas. Zipline has also completed the first drone
deliveries in Nigeria’s Kaduna State. Zipline will
implementing drone operate three distribution centres across the state,
technology in the covering an area of 46,000 sq km and delivering to
approximately 500 health facilities serving millions
healthcare space. For of people.
instance, Rescue Robotics,
a mission to deliver medical The UK’s National Health Service (NHS) launched
its first drone delivery system pilot in Argyll and
supplies to remote areas Bute, Scotland, in 2021. It delivered COVID-19 tests,
in Rwanda and Ghana, personal protective equipment (PPE) and medicines
to some of the UK’s most remote communities.
and the Maryland kidney
delivery for transplant were Drone Delivery Canada worked in partnership
successful missions proving with the University of British Columbia to deploy
drones to the Stellat’en First Nation.
the usefulness of drones.”
- Rashmi Pimpale, Alphabet subsidiary Wing launched its first
commercial drone delivery service in a US metro
CEO, Research and Innovation area on April 7 in the Dallas-Fort Worth Metroplex
Circle of Hyderabad (RICH) to several thousand suburban homes. The drones fly
health and wellness products from Walgreens directly
dropped onto a ship anchored off the island. The to customers’ homes.
2.7km, a seven-minute flight took place off Marina
South Pier, under a one-year deal inked between Last year, UPS Flight Forward began making
shipping giant Eastern Pacific Shipping (EPS) and COVID-19 vaccine deliveries via drone for Atrium
local startup F-drones. Each drone can take up to Health Wake Forest Baptist medical centre in
5 kg of supplies and travel up to 5km offshore each Winston-Salem, North Carolina, using packaging
way. from Cold Chain Technology developed for drones.
UPS’s drone airline received first-of-its-kind approval
In Singapore, the National University Health from the FAA to carry alkaline and lithium batteries
System (NUHS) makes use of drones, robots and to power temperature monitoring devices required
touch-free technology on its various campuses. by the US Centers for Disease Control and Prevention
The use of drones to conduct building inspections for COVID-19 vaccine transport.
has been rolled out since October last year, with
Alexandra Hospital, Ng Teng Fong General Hospital Says Aarti Chitale, Senior Industry Analyst,
and NUH having gone through two rounds of Healthcare & Lifesciences, Frost & Sullivan, “Across
inspections. These checks will be done quarterly. Asia Pacific, drone usage is gaining traction in line
with that of India. Countries including Singapore,
Thailand started testing medical deliveries to South Korea (which are amongst the developed
people in remote areas under a new project called nations in APAC) as well as Malaysia, Indonesia
Delivers Wellness. Thailand Post is leading the project (amongst the emerging/ developing nations), have
and has already been distributing medical equipment built stringent drone laws for the commercial-scale
to hospitals across the country and delivering medical usage of these machines.”
supplies from hospitals to patients.
It may be noted that across Singapore, the
The Middle East and the US market country’s law mandates the registration of any
drone (whether private or commercial) with the
Moving from Southeast Asia to the Middle East Civil Aviation Authority of Singapore (CAAS) for
Asia, The Abu Dhabi Department of Health (DoH) any drone weighing higher than 250 grams and it is
announced that the Emirate of Abu Dhabi is adopting followed by obtaining the relevant certifications and
advanced drones to distribute and transfer medical licenses. Similarly, Malaysia does not permit flying
supplies within the healthcare sector. The project drones above 400 feet and within 50 meters of any
collaborates between the DoH, the General Civil person, vehicle or structure which is not associated
Aviation Authority, SkyGo (a drone provider), and with the drone flying.
Matternet, the logistics service.
According to the South Korea Office of Civil
In 2020, the US-based drone logistics company Aviation, drones for commercial usage require
Volansi piloted the first delivery of temperature- registration with the Ministry of Land, Infrastructure
controlled vaccines in the US, in partnership with
Merck. San Francisco-headquartered Zipline has

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BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Key companies in the drone market being planned via drone from the neighbouring
country, all aspects need to look into before giving
● DJI (China) a go-ahead. It may be noted that a proper tracking
● 3D Robotics (U.S.) mechanism should be in place for countries having
● Parrot Drones (France) international borders to ensure that drones are not
● AeroVironment Inc. (U.S.) misused for human fatality.
● Kespry (U.S.)
● Delair (France) Apart from the above concerns, investing in
● Textron (U.S.) drones in rural areas can be quite challenging due
● Autel Robotics (U.S.) to lower affordability leading to significantly lower
● Yuneec (China) adoption. Drones run on batteries and limited
● Northrop Grumman (U.S.) battery life could limit their usage across longer
● BAE Systems (U.K.) distances, especially in the rural/ remote locations
● Isreal Aerospace Industries Ltd. (Israel) in India. Also, drones do require the corresponding
● Elbit Systems Ltd. (Israel) infrastructure such as landing stations, as well
● Zipline (U.S.) as communication systems, with good Internet
connectivity, a lack of which will have a direct impact
Source: Fortune Business Insights on their usage.

and Transport with the operator requiring a legible When delivering temperature-sensitive
license for operation in addition to the restriction medical supplies such as cold-stored vaccines, the
on flying height, vicinity of structures and people environmental temperature, humidity and air and
amongst other things. weather conditions can not only deplete the quality
of the medical supplies but also delay the supply
The India market timelines.

According to a recent report from the Federation The future
of Indian Chambers of Commerce & Industry
(FICCI) and EY, there are estimates that the drone There is tremendous scope for drones in the
market in India will surpass $900 million in the healthcare sector. However, the easy availability of
next two to three years. A report by 6Wresearch drones will lead to security issues where terrorist
states that the Indian UAV market is poised to grow attacks take place using drones. With proper
at a CAGR of 18 per cent during 2017–23, in terms regulations in place, the drone culture in India’s
of revenue. BIS Research predicts that the market health sector can be a win-win situation for the
for commercial drones superseded the military government, healthcare providers and patients.
market by 2021, cumulatively hitting approximately
$900 million. Says Dr Neeraj Sood, Professor and Vice Dean-
Research, University of Southern California Price
The Indian Council of Medical Research (ICMR) School of Public Policy, “The need for drones is
recently released ‘Guidance Document for use of much more in India than in other places. A major
Drones in Healthcare’. The institute has published challenge to the application of drone technology in
the document based on the field experience in the healthcare space would come concerning the
Manipur and Nagaland. The objective of this regulatory infrastructure. The government must
document covers areas such as how to obtain get all stakeholders together and build the required
regulatory approvals from competent authorities for infrastructure for smooth operations of the drone
various kinds of drones and utilising air space for technology for healthcare. For countries like South
delivering medical supplies restricted to medicines, Korea, where things are generally more regulated and
vaccines and surgical materials. Over 15 startups in the people are more accepting of these regulations,
India are into manufacturing drones. and it’s smaller in size when compared to India, it
might be faster for them to move forward with drone
Challenges technology. Also, the application of drone technology
might be easier in other fields such as retail since
There is a general perception that drones will more checkpoints are required in the healthcare
make the matter easy for the healthcare industry. space, making it more stringent. For example,
However, getting regulatory approvals from the temperature monitoring of a blood sample needs to
government for startups and drone manufacturers be done etc.”
can be a daunting task. Also, with many terror attacks
Sanjiv Das
[email protected]

SPEAKING WITH 37

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

“An effective biobank provides high-quality

and affordable biospecimens to drive research,

aiding live-saving scientific discoveries”
To study disease risk and understand
drug response numerous biobanks have «
emerged to facilitate genetic risk screening
and pharmacogenomics in clinical research/ Erik Steinfelder,
pandemic studies. These biorepositories preserve Global Enterprise
biospecimens like blood samples, gene pools, Relationship Lead,
biopsy material, and even human microbiota. Thermo Fisher
Numerous efforts are emerging to maintain Scientific
biological samples through sustainable biobanking
practices. Understanding that biobanks can be Fukushima disaster are collected, monitored, and
landmark resources for translating genomics used for research.
into clinical care, and sharing insights and
information critical to advancing science, Erik How can the potential of biobanks be
Steinfelder, Global Enterprise Relationship Lead at harnessed in developing novel healthcare
Thermo Fisher Scientific explains more about the solutions?
emerging biobanking trends. Edited excerpts;
In the journey of scientific discovery, samples are
How has Asia progressed with biobanking in often needed but not always easily made available
the last decade? or shared. Sample banks are beneficial as they allow
researchers with the means to access the collection,
The demand for more, high-quality, and clinically storage, and management of samples from a range of
annotated biospecimens will increase, primarily individuals – be it, healthy volunteers or patients.
due to the unprecedented level of genomic, post-
genomic, and personalised medicine research However, despite the availability of samples,
activities. Biobanks will need to adopt industry- better alignment is needed between the different
wide standard operating procedures, methods for stakeholders on what samples are needed in high
quality assessment, less expensive methods for demand, and conditions whereby samples are
sample storage/distribution, and objective methods allowed to be shared.
to manage scarce biospecimens. Public-private
partnerships will also be important, as well as the Biobanks can sometimes be unwilling to share
number and diversity of available biospecimens, cost samples outside of their own institutions, and
management, and the realisation that an effective researchers can operate in silos when samples are
biobank is one that provides high-quality and not shared. This can limit access and contribute
affordable biospecimens to drive research that aids to difficulty in obtaining biological samples for
in live-saving scientific discovery. research. Fortunately, we are seeing some successful
examples in Japan, China, Korea, and Australia
Across Asia, countries active in biobanking are where this has been improved over time and more
in various stages of progress. Advanced biobanking co-operation is taking place.
markets such as Japan, China, Korea, and Australia
have been very active, benefitting from long standing How is Thermo Fisher addressing the
support from their government’s strategic plans. biobanking trend in the Asian region? How
Countries such as Indonesia and Vietnam are also do you foresee prospects?
seeing strong developments in recent years.
The APAC region is unique, in that, when there
Some notable projects include the creation of is a plan in place, infrastructure development is
a precision medicine initiative with a polygenic accelerated, and biobanks come to realisation much
risk score for all participants in Taiwan, and the faster than in other parts of the world. Thermo
Tohoku Medical Megabank Project in Tokyo with Fisher Scientific’s expertise in biobanking and
samples from participants that were affected by the

38 SPEAKING WITH

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Since the beginning of COVID-19, and scientific communities by ensuring the quality
numerous biobanks have emerged of samples and data to support various phases of
to facilitate studies of the virus and research – be it at the discovery or clinical trials.
disease, how it spreads, and why some Further, our extensive capabilities enable us to
people are more susceptible than bridge connections among scientists and ultimately,
others. Biobanks also provide pre-COVID contribute to catalysing the progression of research.
samples for biological comparisons
and further research. Going beyond the We continue to innovate and provide solutions
pandemic, biobanks play a crucial role that meet the demands of research today, and we will
in all disease areas. For decades now, continue to work with various partners in the Asia
unique collections of material, serum, Pacific region to solve biobanking challenges and
tissue, and a variety of cells have been realise scientific breakthroughs.
stored to help researchers understand
non-communicable diseases as well. How should governments prioritise
There are many critical considerations
for biobanks, especially because of biobanking activities? Are there challenges
the safety implications of preserving
sample integrity. in fully optimising these complex biological

strong local connections help customers actualise libraries?
their biobank plans. We track the latest findings
presented at biobank conferences and events to Since the beginning of COVID-19, numerous
identify trends in the Asia Pacific region, to develop biobanks have emerged to facilitate studies of the
bespoke solutions according to needs. We often see virus and disease, how it spreads, and why some
a significantly larger size of sample collection in people are more susceptible than others. Biobanks
APAC. These quantities can create a higher demand also provide pre-COVID samples for biological
for biobanks to automate the storage and processing comparisons and further research.
of samples. However, this also needs to be done in a
safe way that preserves the sample integrity. Going beyond the pandemic, biobanks play a
crucial role in all disease areas. For decades now,
How are you leveraging investment or unique collections of material, serum, tissue, and a
collaboration in the biobanking arena? What variety of cells have been stored to help researchers
plans are in the pipeline? understand non-communicable diseases as well.

We leverage our extensive partner network For example, Osteogenesis Imperfecta (OI), a
with biobank associations and conferences as well genetic disorder that affects approximately 15,000
as organise events such as webinars and training people globally (approximately 1 in 10,000 to
to encourage knowledge sharing within the larger 20,000 people) and prevents the body from building
biobanking industry. We view biobanking as a strong bones, only has 385 samples with associated
mindset. clinical data. Insight into the molecular mechanisms
behind individual diseases like OI can only be
I liken it to a spiderweb where a community obtained from the investigation of human biological
of like-minded scientists can share and challenge samples. These rare disease collections hold an
perspectives. In this analogy, Thermo Fisher is the immeasurable wealth of information, much of it yet
spider – we use our end-to-end expertise to help to be revealed.
partners build their biobanking capabilities. In fact,
we built a community specifically around biobanking There are many critical considerations
in which we regularly organise events and share for biobanks, especially because of the safety
materials that promote sustainable, ethical, and implications of preserving sample integrity.
quality research. Optimisation needs to be considered in processes
around sample collection and preparation,
We then extend the web and enable greater automation equipment, cold storage controls,
cooperation and collaboration within the biobanking wireless monitoring, consumables, etc.

The experience and knowledge being developed
on how to store samples under the correct
conditions–and access them for the benefit of the
patient–is a welcome source of information and
inspiration for many biobankers working in different
arenas. The time is now to invest in even better and
stronger infrastructure going forward.

Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 39

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

“Unique demands of CGT biomanufacturing

necessitate an early-stage collaboration

between suppliers and biomanufacturers”
Asurge in pharmaceutical R&D has led to
an increase in the number of Cell & Gene «
Therapy (CGT) candidates being developed.
The goal has been to develop cost-effective and Narayana Rao,
efficient cell and gene therapies while focusing
on biomanufacturing innovations. It’s now Vice President
becoming essential to outsource manufacturing
services that can leverage innovative cutting- of Biopharma,
edge biomanufacturing technologies to enhance
efficiency and flexibility in CGT. Narayana Rao, Asia Pacific
Vice President of Biopharma, Asia Pacific Middle-
East Africa at Avantor interacted with BioSpectrum Middle-East Africa,
Asia and shared his insights on Asia’s CGT
Biomanufacturing ecosystem. Edited excerpts; Avantor

What are your insights into the current state Which emerging trends are shaping the
of biopharmaceutical R&D? future of biomanufacturing?

The global biopharma market has been and Some of the key trends that have emerged in the
continues to be one of the fastest-growing sectors pandemic era include the explosive growth of new
in the healthcare industry. According to Fortune modalities and the need for rapid industrialisation.
Business Insights, the global biopharmaceutical New platforms such as cell therapy, gene therapy
Contract Manufacturing Organisations (CMO) and mRNA are complementing more traditional
market is projected to reach $26.49 billion in 2028 platforms such as mAbs, and these labs are looking
with a compound annual growth rate (CAGR) of 12.6 at more therapeutic areas such as Alzheimer’s,
per cent in the 2021- 2028 period. Parkinson’s and Infant Spinal Muscular Atrophy.

In parallel with the evolution of the industry is the These sources of research and development,
growth of the cell and gene therapy (CGT) platform along with the usage of these platforms to support
as an avenue of innovation. The emergence and a wide landscape of therapeutic areas, lead to
evolution of precision medicine today offers hope for many intersections and overlaps that bring about
treating previously incurable life-threatening diseases opportunities to collaborate and transform the
such as cancer. Moreover, the rising prevalence of industry.
chronic disorders coupled with an ageing population
is expected to fuel the growth of the CGT market to Ensuring launch excellence and strengthening
almost $15.5 billion by 2025, further doubling to resilience in end-to-end supply chains are two
nearly $34 billion by 2030. This trend suggests that other factors that will be focused on in upcoming
these pharmaceutical companies are increasing their years. This is an area Avantor has increasingly been
research and development (R&D) efficiencies through focusing on by investing in the latter. For example,
persistent investments as well as collaborative to better serve its customers in the AMEA region,
research efforts, with hopes to see greater returns Avantor in May announced a new Manufacturing
on their investment in the long run. The increase in and Distribution Hub in Singapore, by integrating its
pharmaceutical R&D has resulted in a sharp increase existing distribution facility with new manufacturing
in the number of cell and gene therapy candidates operations. The new hub, which provides a range
under development. This has made it necessary to of services including quality control and inventory
outsource manufacturing services to develop cost- management expertise, aims to bring Avantor
effective and efficient cell and gene therapies, while solutions closer to regional customers and strengthen
emphasising new biomanufacturing innovations. global supply chain capabilities.

Lastly, digitalisation and rapid adoption of
Industry 4.0 technologies will also revolutionise all
aspects of biopharma. For example, cloud-based
digital solutions can be tailored to the needs of
the lab and can be used to track and document

40 SPEAKING WITH

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

every stage of the scientific journey, making lab enhance services across key production service
and inventory management efficient and easy to segments such as Design Consulting, Planning and
replicate. This can allow scientists the freedom to Materials Management, Production Readiness and
focus on their work while enhancing coordination Critical Environment and Sanitation. On the whole,
between them. coordinating with an end-to-end supplier can help
enhance every step of the CGT cascade ranging from
What are the challenges that you anticipate in consumables such as cGMP chemicals, single-use
the CGT sector? solutions, equipment and sera, production (upstream
processing, downstream purification, final fill),
Two main challenges in the CGT sector logistics support, environmental control as well as
include scalability and manufacturability, which staffing expertise.
are prevalent throughout the industry. Despite
the growth in the CGT sector, advanced-therapy How do you see the opportunities for Asia’s
capacity remains insufficient in the industry.
According to BioPlan’s 18th Annual Report and Cell and Gene Therapy industry?
Survey of Biopharmaceutical Manufacturing
Capacity and Production, an upcoming ‘capacity In the coming years, rapid advancements in
crunch’ will cause shortfalls for the CGT industry regenerative medicine are anticipated to provide
of up to 500 per cent and is looking to increase more effective solutions for existing chronic
significantly over the next 5 years. conditions. A substantial number of companies
in growing markets, such as China, India and
Rising shortages and lack of scale-up and South Korea are striving to capitalise on untapped
inefficiencies in production can lead to hindrances opportunities in the market, thereby driving the
in clinical potential. This includes a lack in ready-to- market.
use packaged materials at an appropriate scale, as
well as GMP availability of raw materials with supply The sector’s growth is additionally fuelled by
chain visibility and controlled manufacturing. Other fund and regulatory support from local government
key constraints include the need for specific storage bodies and regulatory agencies. For instance, in
conditions and traceable logistics, sterile process August 2020, the government of South Korea passed
environments, and the requirement for highly trained an Act on the Safety and Support of Advanced
and efficient personnel. Regenerative Medical Treatment and Medicine to
establish a regulatory system for patient safety during
How could biopharmaceutical companies in quality control and clinical trials and to strengthen
the CGT space overcome these challenges? the regulatory support for regenerative medicine
development. The implementation of the Act is
Firstly, investing in high-quality materials and expected to enhance clinical studies and approvals of
risk management processes can minimise upscaling regenerative medicine in South Korea.
risks. By implementing early risk assessment systems
and eliminating manual steps as early as possible, Though CGT represents the next frontier in
manufacturers are better able to maintain optimised biomanufacturing, several capability gaps exist
pharmaceutical quality systems. making upscaling of the therapies from the lab
to the patient a challenge. The unique demands
Several upscaling risks can also be minimised of CGT biomanufacturing necessitate an early-
by utilising single-use and closed-system stage collaboration between suppliers and
processing. Customisable sampling platforms such biomanufacturers to enable successful process
as Avantor’s OmniTop Sample Tubes system with implementation and regulatory compliance.
an adjustable volume sampling system (AVSS) are
beneficial in CGT due to the precision and control CGT manufacturers can collaborate with suppliers
they offer while drawing the sample, eliminating who are proficient in both the materials and single-
the volume loss typically associated with these use technology space to adopt technical, quality
scenarios. On the other hand, the implementation and regulatory best practices needed to facilitate
of closed-system processing using ready-to- consistent product quality. Through collaborative
use sterilised solutions mitigates the risk of efforts between manufacturers and suppliers,
contamination and enhances speed and flexibility resilient support systems can be established by
while facilitating automation. incorporating innovative/flexible material workflows,
reducing system-based risk and implementing robust
Thirdly, coordination with suppliers can also formulation strategies.
assist with ensuring efficiency in production work
environments. Technical expertise can be used to Hithaishi C Bhaskar
[email protected]

SPEAKING WITH 41

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

“Many countries in APAC lack

digital infrastructure to store

and process data efficiently”

GE Healthcare, soon to become an «
independent public company in 2023, is
poised to achieve even greater speed and Chris Khang,
agility in its response to the industry’s needs.
This includes their efforts in advancing Precision President & Chief
Health, a key priority in Singapore’s healthcare
reform plan to refocus the sector on patient-centred Executive Officer,
preventive care. BioSpectrum Asia spoke to Chris
Khang, President & Chief Executive Officer (ASEAN, (ASEAN, Korea and
Korea and ANZ), GE Healthcare at length on how
the company is strengthening digital healthcare ANZ), GE Healthcare
in Asia Pacific (APAC). Edited Excerpts;
Edison Platform: GE Healthcare is opening
What are the major products/technology the path towards precision health through its
being rolled out to enhance the concept of powerful artificial intelligence platform, Edison.
precision healthcare within APAC? It can combine data sets from multiple healthcare
networks, modalities, vendors and technologies to
The Personalised Health Index developed by deliver the insight clinicians need to care for their
Roche and leading public health experts shows that patients.
Asia Pacific has the potential to become a strong
leader in personalised healthcare, with Singapore Command Centre Software: The pandemic
ranking at the top. While personalised healthcare is has compelled hospitals to think strategically
in its infancy worldwide, the index also highlights about efficiently managing critical resources
that it is gaining significant momentum in Asia. like mechanical ventilators and ICU beds. GE
Healthcare worked with Omi Medical Centre in
Artificial Intelligence (AI) plays a crucial role Japan to set up its command centre in April 2021,
in precision healthcare, as it can help make sense which has increased its management efficiency
of large amounts of clinical data gathered and significantly. Even during high bed occupancy, the
turn them into insights for healthcare providers overtime hours of medical staff were reduced by 44
and clinicians. GE Healthcare has a suite of per cent in 2021 compared to the year before.
products that leverages AI technology to improve
the accuracy and speed of diagnoses, help raise Besides working on our own suite of products,
efficiency in decision making, or expand access to we also have a healthcare accelerator supporting
care. startups that develop promising, low-cost med-tech
technologies specifically designed for emerging
Below are three examples: markets. One of the startups that we are working
VscanAir: In 2021, GE Healthcare introduced with is Tricog – a predictive healthcare analytics
its latest pocket-sized colour ultrasound scanner, firm focused on improving survival rates of heart
Vscan Air. It is a handheld, wireless device that attacks in India by reducing the average time
beams images from the ultrasound probe to an app between symptoms and treatment.
on a smartphone – bringing an essential tool to the
point of care. Through an ecosystem of AI-powered What are the current challenges facing the
applications, Vscan Air has made it easier to acquire precision healthcare market in APAC?
and interpret high-quality ultrasound images
wherever care needs to be delivered. This has The first challenge involves recognising and
enabled doctors to diagnose patients even in rural demonstrating the value precision health brings
and remote areas of Asia. to the healthcare industry. Many stakeholders
need to come on board for it to succeed, including

42 SPEAKING WITH

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

governments, payers, providers and patients. (MoU) with Seoul National University Bundang
Thankfully, we are beginning to see countries in Hospital (SNUBH) earlier this year. The partnership
APAC realise its value and move toward patient- will allow SNUBH to leverage our Edison Digital
centred care and data-enabled solutions across Health Platform and other services within its
the continuum of care. For example, in Singapore, hospital system. Through this collaboration, we
the government recently launched Healthier SG. also aim to support and accelerate Korean startups
This healthcare reform focuses on improving the in the development and deployment of clinical and
health of all Singaporeans by working with family operational applications on the platform.
physicians to develop a personalised health plan.
Based on their profiles, they may also be encouraged On a global scale, we have partnered with Elekta,
to go for nationally recommended health screenings a leader in precision radiation therapy, to provide
and vaccinations. hospitals worldwide with a comprehensive and
holistic offering across imaging and radiotherapy for
Finally, the management of massive amounts cancer patients. We hope to meet the crucial need
of data and clinical information is a critical for radiotherapy solutions across both developed
challenge for hospitals and clinics in the region. and developing markets through this partnership.
Precision health relies on getting data from
patients and turning them into actionable insights Which other digital health areas are a
for practitioners. However, many countries in
APAC lack the digital infrastructure to store priority for GE Healthcare? What are the
and process this data efficiently. According to
the HIMSS Analytics Infrastructure Adoption plans in the digital healthcare space in the
Model (INFRAM), which assesses technology
infrastructure adoption and maturity, the coming years?
participating hospitals in APAC were at stage 2.3
(out of 7) on average. This shows that countries in Burnout is a common issue plaguing healthcare
the region need to continue building a more robust workers in APAC and worldwide. For example,
digital infrastructure that can support the growth of a July 2021 study by Singapore’s Institute of
precision health. Mental Health found that primary care doctors
felt higher anxiety, depression, and burnout rates
GE Healthcare aims to accelerate digital than before the pandemic. Technologies like AI
transformation to enhance efficiency and improve and digitalisation are critical tools that can enable
patient outcomes. For instance, Edison Digital doctors to diagnose and treat patients quickly and
Health Platform is designed to seamlessly aggregate accurately. But more crucially, they also lighten the
data from multiple sources and vendors to enable workloads of healthcare workers and streamline
clinical applications that support integrated care workflows across the healthcare institutions, thus
pathway management and holistic views of each bringing overall efficiency through the system.
patient.
The pandemic has also highlighted the inequity
Are you planning new investments or of healthcare access globally. 43 per cent of people
worldwide do not have healthcare services within
collaborations to increase adoption of an hour’s walk of their home, and nearly 10 per cent
do not have access to facilities within a one-hour
precision healthcare within APAC? drive. We hope to improve access to care through
a variety of technology-powered innovations such
We’ve inked partnerships with several leading as telehealth services, which can connect clinical
healthcare providers in Asia Pacific to accelerate the experts in one city to patients in remote or rural
adoption of precision healthcare. areas; and portable, handheld medical devices that
bring crucial diagnostic technologies to wherever it
Recently, we have announced a new is needed most.
collaboration with the National Cancer Centre
Singapore (NCCS) – a first of its kind for GE For example, in May 2022, we entered the
Healthcare in the APAC region. The partnership will homecare segment by investing up to $50 million
develop new AI-powered solutions for data analytics in an Israeli startup Pulsenmore. Through this
and clinical workflows, combining GE Healthcare’s investment, we aim to accelerate the global adoption
Edison Digital Health Platform and related imaging of Pulsenmore’s homecare ultrasound solutions,
and monitoring capabilities with NCCS’s deep allowing women to perform ultrasound self-scans
expertise in research and development, testing and at home and receive fast clinical feedback from
consultation. healthcare professionals.

We also signed a memorandum of understanding Dr Manbeena Chawla
[email protected]

PEOPLE NEWS 43

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com Lisa Renkin

OPPI appoints Vivek Sehgal joins
as new Director-General
AusBiotech
The Organisation of Pharmaceutical Producers of India (OPPI) has appointed
Vivek Sehgal as its new Director-General (DG). Sehgal takes over from KG as Director,
Ananthakrishnan who has been with OPPI since 2020. Sehgal has close to
three decades of cross-sectoral experience on policy issues with central/ Investment

state governments, regulators, and other AusBiotech has announced
key stakeholders. In his most recent role, an expanded investment
he was the Assistant Secretary-General, attraction offering has
PHD Chamber of Commerce & Industry commenced in line with a
where he handled varied sectors including new investment attraction
- Health, AYUSH, Defence and Homeland strategy. This strategy was
Security, Capital and Commodity Markets, developed in response to
Corporate Affairs, and Direct Selling. His feedback from members
work on policy advocacy in sectors like and industry stakeholders
health, AYUSH, IT, and defence has been during the development
significantly successful in its acceptance of the Biotechnology
by the concerned ministries. He will work Blueprint; A Decadal
towards building OPPI’s commitment Strategy for the Australian
towards fostering continuous research and development and enabling Biotechnology Industry.
healthcare access for all. OPPI will continue to drive policy and advocacy To drive this expanded
discussions with the government and endeavour to work together with portfolio, Lisa Renkin has
various stakeholders on industry-related issues, to implement sustainable recently joined AusBiotech
and patient centric solutions. as Director, Investment.
Lisa is well known to
Australia’s Telix Pharma appoints many in the sector and
new CEO for US operations has worked collaboratively
with AusBiotech and sector
Australian firm Telix Pharmaceuticals has announced that Kevin stakeholders over many
Richardson, a senior global executive with a career focus on years. Most recently Lisa
sales, marketing and business operations in the oncology and was the Victorian Deputy
radiopharmaceutical markets, will commence in the role of the Chief Commissioner to China
Executive Officer, Telix Americas, effective immediately. Richardson is an with responsibility for
accomplished business leader with 25 years’ experience in the healthcare the investment attraction
industry and a proven track record in building and leading portfolio. Prior to that
successful sales, marketing and commercial teams appointment she worked at
while working cross-functionally to develop and the Burnet Institute, leading
deliver effective growth strategies to support new various commercialisation
and emerging medical devices and therapies activities including the
to healthcare providers, including the field of expansion of the Institute’s
nuclear medicine. Most recently, Richardson was China programme, and
the Chief Operating Officer of UroShape Medical, contributing to AusBiotech’s
a technology company which has developed and global investment programme
successfully commercialised a medical device for a in an advisory capacity.
large, undertreated segment in the women’s health
market. Prior to this, he spent seven years in
the America’s division of Sirtex Medical, an
Australian-founded radiopharmaceutical
company which commercialised a device for
the treatment of liver cancer.

44 SPOTLIGHT

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

“The concept of anti-ageing should, therefore,
include youth preservation as part of its objective”

Dr Joe Chang with Dr Helen Knaggs and Dr Mark Bartlett at Nu Skin Center for Anti-Aging Research (Provo, Utah)

Operating in approximately Enterprises. With over 35 years of address skin ageing form a significant
50 markets worldwide in experience in the pharmaceutical percentage of this market.
the Americas, Asia, Europe, and dietary supplement industries,
Africa and the Pacific, Nu Skin is Dr Chang enjoys a comprehensive An integrated approach of modern
revolutionising the industry with knowledge of both of these industries and ancient medicine to beauty and
products that offer comprehensive and serves as a member of the wellness is attractive to consumers.
anti-ageing concerns. By targeting Executive Committee for Nu Skin But the holistic approach of ancient
the ultimate sources of ageing, Nu Enterprises. medicine system, for example
Skin’s ageLOC products dramatically Ayurveda medicine, does not have
diminish the appearance of ageing. Edited excerpts; enough scientific understanding of the
Backed by more than 35 years of ingredients that are used in Ayurvedic
scientific research, Nu Skin develops What are your views on the medicine. In order to extract more
innovative products including Nu Skin growth and challenges of the anti- value, a scientific evaluation could
personal care, Pharmanex nutrition ageing market in Asian countries? increase its appeal to a wider
and the ageLOC anti-ageing brand, audience.
which includes an award-winning With the success of medicine
line of beauty device systems. To and new technologies, people are Whilst anti-ageing products
find out more about the company’s living longer. With the rate of ageing have a strong appeal to an older
expertise in the area of anti-ageing, in Asian countries accelerating and population, younger consumers are
BioSpectrum Asia spoke to Joseph exceeding the rate of ageing in the more attracted to products that can
Y. Chang, PhD, Chief Scientific western world, the anti-ageing market preserve their youthfulness. This is
Officer and Executive Vice President- in Asia will grow to around $120 billion likely to be a growing trend in the
Product Development, Nu Skin by 2030. And skin care products that future. The concept of anti-ageing
should, therefore, include youth
preservation as part of its objective.

SPOTLIGHT 45

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

How do you foresee the Dr Joe Chang What new products are in the
intervention of science and PhD, Chief Scientific Officer and pipeline at Nu Skin for the Asian
technology in anti- ageing in the market? What are the major future
coming years? Executive Vice President- plans?
Product Development,
Looking for the sources of ageing Nu Skin Enterprises A Nu Skin product related to
and identifying the cause of aging is promoting metabolic health has
vital. Intervening at an earlier point of exclusive to Nu Skin found already been launched in some
aging will lead to a better outcome. anthocyanins to have a salutary markets. Nu skin products undergo
More research and understanding of effect on metabolic health. These a rigorous process to ensure a safe
the overall expression of the genes, are powerful compounds with and effective product. Part of the
alongside identifying and targeting potent antioxidant effects found in product development pathway at Nu
gene expression patterns, specific dark purple fruits and vegetables. Skin, is a six-step process, called
genes which influence aspects of In addition to their antioxidant 6S process, to check the natural
ageing, is required. properties, some anthocyanins also ingredients which are being used in
support healthy inflammatory balance the products. This process ensures
When it comes to the healthy and immune benefits. Research validation of the safety and efficacy
ageing of our skin, modulating sun revealed that certain anthocyanins of our products.
exposure plays an important role. such as cyanidin and delphinidin
Oxygen free radicals generated by are the most effective types of The company is also fully
the ultraviolet (UV) rays cause skin anthocyanins at protecting cells from committed to developing products
wrinkles because such free radicals inflammatory-induced damage. Some that are suited for each region of the
can damage the two structural of the superfoods that are rich in world. Nu Skin has established a
proteins, Collagen and Elastin, which cyanidin and delphinidin are black leading position in beauty devices and
confer elasticity and firmness in currants, bilberries, and black rice. has launched several devices that
healthy skin The anthocyanins from these three employ proprietary, clinically proven
superfoods support better overall technology to promote healthy skin.
Skin aging occurs differently metabolic health. At Nu Skin, we believe an integrated
between Asians and Caucasians. For approach, beauty from the inside and
example, an uneven complexion is Metabolic health is highly beauty from the outside, is optimum
usually an early sign of aging among dependent on a healthy lifestyle such for beauty and wellness. Clearly,
Asians whereas Caucasians tend as doing regular exercises, having topical skincare products when used
to develop wrinkles earlier instead. a healthy diet, getting adequate with nutritional supplements, are likely
Identifying certain clusters of genes sleep, eating lots of fruits and to provide better benefits, as shown
and addressing gene expression vegetables and stopping smoking. recently by our research.
responsible for such changes is The earlier you adopt a healthy
something that scientists are still lifestyle, the better it is for you. There Are you planning to expand
trying to understand. are a lot of healthy bacteria (aka your presence in Asia with new
probiotics) in our gastrointestinal R&D centres?
Nu Skin had collaborated with tract which help to promote a healthy
scientists from the University of microbiome. There is an increasing Nu Skin has R&D centres in US
Wisconsin in the US to expand the understanding, for example, that and China at present. As of now,
genetic understanding of ageing. To a healthy gut boosts system-wide there are no plans to invest or expand
live healthily and have good quality of immunity, which is an important our research footprint further although
life is something which we live by at aspect of healthy aging. This is collaboration with global research
Nu Skin. illustrative of the importance of institutions is surely something that
orchestrating a holistic approach to we will continue to do.
What role does metabolic overall body’s health and healthy
health play in the process of living in general. Do you see a talent crunch
healthy ageing? How is Nu Skin in the field of science, especially
exploring this link? related to anti - ageing expertise?
How can we improve the skilled
Metabolic health is our body’s workforce in this domain?
biochemistry that impacts key
indicators like cholesterol and There is a huge demand for anti–
triglycerides, insulin sensitivity, ageing products. At Nu Skin, there
blood pressure and blood sugar. It are already more than seventy-five
comprises a full range of biochemical qualified scientists who are focused
processes that affect every part of our on anti-ageing research. Globally,
body. Stress, erratic work hours, poor there are many scientists who are
sleeping habits and irregular eating studying ageing in academic centers.
can throw our body chemistry out of Japan is leading and setting an
sync. Unhealthy lifestyle choices can example by doing extensive research.
also affect one’s body by impacting The demand is so high that even
vital organs health, producing Google has established a company to
free radicals, creating metabolic study ageing. So, the interest in anti-
imbalance, microbiome imbalance ageing is growing and something that
and gut health. has a bright future.

A seven-year research effort

46 R&D NEWS

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Thailand’s innovative ‘Detachable and
Dissolvable Microneedles’ to boost telemedicine

Researchers at Chulalongkorn (1,000 microns). It can cater to those who need to
University in Thailand have quickly dissolve into the skin have frequent subcutaneous
developed an innovative giving a different sensation injections so that they do not
‘Detachable and Dissolvable than an injection with a have to waste their time and
Microneedle’ that makes typical syringe. Microneedles money travelling to receive
injections easy and painless services from the healthcare
for everyone, while also profession. It is also suitable
significantly reducing medical for those who are afraid of
wastes. The Detachable and needles or do not dare to give
Dissolvable Microneedle set themselves injections. The
consists of two components: innovation will help healthcare
a microneedle patch, and a professionals in providing
moisture patch resembling telemedicine services without
a wet tissue. The innovative patients having to come to the
microneedle contains active hospitals for their injections in
medication in a tiny needle the future, which is really cost
of no more than 1 millimetre inefficient.

Japan discovers new type Indo-US team
of bone repairing material
3D-prints nanoparticle
Ceramics and metals have been used for a while as
structural materials to repair bones and joints. In the coated N95 mask
past, scientists engineered bioinert materials, which do
not bond to bones directly; bioactive materials that can with 5 year shelf life
bond to bones; and bio-absorbable materials that are
categorised in bioactive materials but they are absorbed Researchers from Amity University
Haryana (AUH) and the University of
by the body over time and Nebraska, US, have developed a reusable,
are replaced by advancing recyclable, washable, odourless, non-
bone tissue. Now, a fourth allergic and anti-microbial N95 mask
type of bone repairing by using 3D printing technology. The
materials has been found: four-layer mask whose outer layer is
a bio-responsive ceramic made up of silicon has a shelf life of more
that interacts with an than five years depending upon the use.
enzyme found in blood to The mask can be modified according to
be absorbed into the body the requirement by changing the filter
at a precise and predictable configuration according to the place in
rate. The research was done at the Japan-based Institute which it will be used and can help prevent
of Biomaterials and Bioengineering at Tokyo Medical severe lung diseases such as SILICOSIS. A
and Dental University. At the heart of this discovery trademark and a patent have also been filed
is a biological reaction: an enzyme called alkaline for the mask called Nano Breath. A 4-layer
phosphatase (ALP), which is present in human serum filtration mechanism has been provided in
and reacts with various phosphate esters to generate the mask wherein the outer and first layer of
bone mineral known as hydroxyapatite. The researchers the filter is coated with nanoparticles. The
expect the findings of this study will be applied towards second layer is a high-efficiency particulate
designing and developing novel bone-repairing materials absorbing (HEPA) filter, the third layer
with precisely controlled degradation and resorption is a 100 µm filter and the fourth layer is a
rates inside the body. moisture absorbent filter.

AWARDS 47

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

2

1 3
1. Ravindra Boratkar, Managing Director, MM Activ Sci-Tech

Communications Private Limited receiving the Runner-up award
in the category “The Knowledge Hub” for organising the Bengaluru
Tech Summit.
2. Ravindra Boratkar, Managing Director, MM Activ Sci-Tech
Communications Private Limited receiving winner’s award in the
‘The Big Show’ category for organising Agrovision India.
3. MM Activ Group company Asian Convention & Exposition Private
Limited’s team receiving Runner-up award in Merit- Corporate
Category for ‘CIDCO Exhibition & Convention Centre’.

MM Activ bags recognition for exhibition excellence

MM Activ Sci-Tech Communications Private a common platform for the farmers, industry, and
Limited received 3 outstanding awards at the 6th government and bring together every important
edition of Exhibition Excellence Awards (EEA) entity in agriculture to create a better future for the
ceremony held on July 8, 2022 at the India Expo farmers. The vision of Agrovision is to create a more
Mart, Greater Noida. After a gap of two years, the knowledgeable, practical and a smart famer.
EEA came back in physical format in 2022. Over
500 exhibition organisers, trade & professional Another Runner-up award was bagged by MM
associations, trade bodies, corporate heads, venues Activ Group company Asian Convention & Exposition
and meeting, incentive, convention, and exhibition Private Limited in Merit- Corporate Category for
(MICE) stakeholders attend the event. ‘CIDCO Exhibition & Convention Centre’ during
the ceremony. Built on a sprawling 2,00,000 sq.ft.
MM Activ won a Runner-up award in the area, the centre has two large halls for exhibition and
category “The Knowledge Hub” for organising the 1,50,000 sq.ft. convention centre. Both the exhibition
Bengaluru Tech Summit, on the basis of a number and business centres are connected by a bridge.
of conference sessions held at the exhibition Innovatively designed at par with international
between January 2020 and March 2022. Bengaluru standards, the centre sports an aesthetic and
Tech Summit is an initiative by the Department of attractive view.
Information Technology, Biotechnology and Science
& Technology, Government of Karnataka, Software The award was accepted by Ravindra
Technology Parks of India (STPI) Bengaluru. Boratkar, Managing Director, MM Activ Sci-Tech
Jagdish Patankar, Executive Chairman, MM Activ Communications Private Limited. He said, “These
Sci-Tech Communications has been playing a key awards serve as a recognition for hard work that goes
role in curating this event along with the Karnataka into organising and planning large-scale events. Our
government. Currently, in its 25th year, Bengaluru commitment to continue producing high-caliber work
Tech Summit has emerged as Asia’s most prestigious has increased as a result of receiving three awards.”
and sought-after technology event.
In the last 20 years, since its inception, MM
Adding more feathers to its cap, MM Activ Activ has curated over 100 national & international
emerged as a winner in the ‘The Big Show’ category technology conventions with special focus on agri-
for organising Agrovision India, a physical exhibition food and biotechnology. MM Activ is the publisher of
with the greatest number of participating exhibitors. leading B2B digital and print media- BioSpectrum,
Agrovision was conceived in the year 2007 to create nuFFooDS Spectrum and AgroSpectrum from India
and Singapore catering to the APAC region.

48 SUPPLIER NEWS

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

PerkinElmer introduces Agilent improves
next-gen automated gas
chromatography platform analysis speeds

PerkinElmer, Inc., has launched the GC 2400 Platform, an of genomics
advanced, automated gas chromatography (GC), headspace
sampler and GC/mass spectrometry (GC/MS) solution bioinformatics pipelines
designed to help lab teams simplify lab operations, drive
precise results, and perform more flexible monitoring. Agilent Technologies Inc. will use Amazon
Created with productivity in mind for pharmaceutical, Elastic Compute Cloud (Amazon EC2) G5g
food, environmental and industrial analyses, the new instances powered by Amazon Web Services
platform brings together systems, software and a wide (AWS) Graviton2 processors and featuring
NVIDIA T4G Tensor Core GPUs, in
range of columns and consumables to meet customers’ combination with NVIDIA Clara Parabricks’
varied workflow needs. For high throughput lab advanced genomics analysis capabilities,
environments and complex applications, the to significantly improve processing speeds
GC automated sampling capabilities reduces for variant calling workflows on Agilent’s
hands-on time and human error, and the cloud-native Alissa Reporter software.
industry-unique automated This collaboration enables Agilent to
headspace/pneumatics offer streamlined workflow solutions for
technology delivers superior its SureSelect family of next-generation
precision. Monitoring single or sequencing (NGS) assays comprising a
multiple GC 2400 systems, inside wide range of custom and catalogue panels,
or outside the lab, is simple, using including SureSelect Human Exome
the wireless, touchscreen tablet reagents. The integration of NVIDIA
interface running the PerkinElmer Clara Parabricks platform with the Alissa
secondary analysis pipelines enables clinical
Simplicity Vision app. The platform’s icon-driven, 21 labs and researchers to benefit from fast
CFR Part 11 compliant PerkinElmer SimplicityChrom panel-specific data analysis solutions in
Chromatography Data System (CDS) software reduces user a secure and user-friendly cloud software
training and guides teams through their entire GC workflow. environment. Agilent’s SureSelect panels
The software interface is also customisable to address user’s are widely utilised to enrich samples for
unique data, notification and diagnostic needs. specific genes of interest, enabling cost-
effective targeted sequencing.

Illumina, Merck unveil research
test for insights into tumour genome

Illumina has launched a research assay. It will be available globally, technology and validated HRD
test, co-developed with Merck excluding the US and Japan, and technology from Myriad Genetics,
that builds upon Illumina’s will enable researchers to unlock enabling labs to accurately
commitment to broadly enable deeper insights into the tumour detect genomic instability and
comprehensive genomic profiling genome by identifying genetic analyse more than 500 genes
and enhance research critical mutations used in the evaluation simultaneously, including those
to realising precision medicine of homologous recombination relevant to HRD status. HRD
in oncology. The is a genomic signature used to
test adds an deficiency (HRD). The describe when cells are unable to
assessment of Research Use Only effectively repair double-stranded
a new genomic TruSight Oncology DNA breaks. When this occurs,
signature to cells rely on alternative, error-
the distributed, 500 HRD test is a prone DNA repair mechanisms,
market-leading next-generation which may lead to genomic
TruSight sequencing (NGS)– instability and, eventually,
Oncology 500 based assay that tumour formation.
harnesses the power
of Illumina NGS

SUPPLIER NEWS 49

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

BRAND Scientific Equipment
presents new VACUUBRAND identity

BRAND Scientific Equipment VACUUBRAND has evolved global customers are changing.
presents the new VACUUBRAND rapidly in recent years, developing The highlighting of the word
identity which was launched at new innovative vacuum VACUU in VACUUBRAND
Analytica in Munich Germany technology for laboratories, emphasises vacuum technology
recently. The focus is on the research, and engineering. At as the core competence. It
VACUUBRAND promise: the same time, the demands of
Innovative vacuum forms the umbrella
technology enabling for the names of the
customers to run company’s innovative
reliable, safe, and products such as
efficient processes. VACUU·PURE,
This is reflected VACUU·SELECT
both in a new overall or VACUU·LAN.
appearance and BRAND, set in a finer
highlighted by the typeface, defines us
new VACUUBRAND logo. as an integral part of

the Brand Group.

Thermo Fisher Bio-Rad launches
EconoFit chromatography
brings TaqPath column packs

respiratory viral Bio-Rad Laboratories, Inc. has announced the launch
of EconoFit Low-Pressure Prepacked Chromatography
select panel Column Packs to support resin screening experiments in the
development of protein purification workflows. Bio-Rad’s
Thermo Fisher Scientific has launched range of EconoFit Columns provides a wide selection of resins
Applied Biosystems TaqPath in a prepacked format, allowing customers to simply screen
Respiratory Viral Select Panel; a CE- resins and select
IVD-marked molecular assay panel for the optimal
the detection of five common viruses, chemistry for
including those that cause the common different target
cold, bronchiolitis, croup, influenza- molecules. The
like illnesses, and pneumonia. The new packs include
molecular assay panel provides results mixed-mode,
in approximately three hours, testing for cation, and
Adenovirus, Human Metapneumovirus, anion exchange
Rhinovirus/Enterovirus, and resin columns,
Parainfluenza virus, using highly as well as a pack
accurate PCR technology. RNase P and designed for His-tag protein purification. The convenient,
positive controls are included to offer easy-to-use and disposable column format is fully compatible
sample-to-result reliability. The solution with Bio-Rad’s NGC Chromatography Systems and other
is scalable, which allows laboratories commonly used chromatography systems. Columns are
to run from one to 94 samples available in 1 ml and 5 ml sizes. Similar resins can give
simultaneously depending on the needs different results for different target molecules, and with
of the population they’re servicing and Bio-Rad’s EconoFit Column Packs, the customers can easily
can help to identify co-infections. The perform resin scouting to identify the one which yields the
TaqPath Respiratory Viral Select Panel best outcome for their chromatography application.
is for In Vitro Diagnostic Use and is only
available in select EMEA countries.

50

BIOSPECTRUM | AUGUST 2022 | www.biospectrumasia.com

Holistic Approach to Prophylaxis

Two and a half years after the World Health The strategy aims to use primary and booster
Organisation (WHO) declared a Public Health doses to reduce deaths and severe disease, in order
Emergency of International Concern, COVID-19 to protect health systems, societies and economies.
continues to be a global threat to health and society On the way to reaching the 70 per cent vaccination
one way or the other. According to the WHO, globally, target, countries should prioritise achieving the
as on July 22, 2022, there have been 565,207,160 underpinning targets of vaccinating 100 per cent
confirmed cases of COVID-19, including 6,373,739 of healthcare workers and 100 per cent of the most
deaths. As of July 18, 2022, a total of 12,219,375,500 vulnerable groups, including older populations (over
vaccine doses have been administered. 60s) and those who are immunocompromised or
have underlying conditions.
COVID-19 has had an impact on every nation,
with an estimated 15 million lives lost due to However, the WHO and United Nations
excess mortality. With the implementation of the International Children’s Emergency Fund (UNICEF),
COVID-19 vaccine in almost every nation and the now officially United Nations Children’s Fund, on
administration of 12 billion doses worldwide, WHO July 15, 2022, observed that COVID-19 pandemic has
countries have successfully vaccinated, on average, fuelled largest continued backslide in vaccinations in
60 per cent of their populations. With the huge and three decades as the new data shows global vaccination
unprecedented COVID-19 vaccine rollout, severe coverage continued to decline in 2021, with 25 million
illness, hospitalisation, and fatalities have significantly infants missing out on lifesaving vaccines. The
decreased (a phenomenon known as “decoupling of percentage of children who received three doses of
cases and deaths”), allowing civilisations to reopen the vaccine against diphtheria, tetanus and pertussis
and preventing a projected 19.8 million deaths in 2021. (DTP3) – a marker for immunisation coverage within
and across countries – fell 5 percentage points between
The WHO noted that the global COVID-19 2019 and 2021 to 81 per cent.
vaccination rollout is the biggest and fastest in history
but many of those at greatest risk remain unprotected 18 million of the 25 million children did not
– only 28 per cent of older people and 37 per cent receive a single dose of DTP during the year, the vast
of healthcare workers in low-income countries have majority of whom live in low- and middle-income
received their primary course of vaccines and most countries, with India, Nigeria, Indonesia, Ethiopia
have not received booster doses. and the Philippines recording the highest numbers.
Among countries with the largest relative increases in
While vaccines have saved countless lives, the number of children who did not receive a single
they have not substantially reduced the spread of vaccine between 2019 and 2021 are Myanmar and
COVID-19. Innovation is needed to develop new Mozambique.
vaccines that substantially reduce transmission, are
easier to administer and give broader and longer- The historic backsliding was due to many factors
lasting protection. including an increased number of children living
in conflict and fragile settings where immunisation
The WHO further noted that the global COVID-19 access is often challenging, increased misinformation
vaccine supply is now abundant with yearly and COVID-19 related issues such as service and
manufacturing capacity of 11-16 billion vaccine supply chain disruptions, resource diversion to
doses, and ample volumes available for lower income response efforts, and containment measures that
countries through contracts and donations via the limited immunisation service access and availability.
COVAX facility, regional mechanisms, and bilateral
approaches. For these countries, over $3 billion in Dr Tedros Adhanom Ghebreyesus, Director-
external financing has been allocated to support General, WHO has rightly pointed out that planning
vaccine delivery including through substantial multi- and tackling COVID-19 should also go hand-in-hand
partner technical support. with vaccinating for killer diseases like measles,
pneumonia and diarrhoea. It’s not a question of
The WHO has also published an update to the either/or, it’s, indeed, possible to do both.
Global COVID-19 Vaccination Strategy on July 22,
in response to the spread of Omicron subvariants, Narayan Kulkarni
advances in vaccine evidence, and lessons from the Editor
global vaccination programme.
[email protected]


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