Microbioz India, September 2022 Lab Edition

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Cover Story 10

Pharmaceutical Roots: ‘Breaking open the head’ with ibogaine hydrochloride

Featured Article 1104
1289
Speeding up development of a hypoallergenic haircare formulation

Business News

Inhalation Sciences signs IRS contract worth 1.39 million SEK with new
US respiratory pharma client

Product Launches 40

Failsafe monitor to shut off your HPLC if a solvent reservoir runs dry

Microbioz India, September 2022 | 6

Microbioz India, September 2022 | 7

abernanthe iboga (iboga) is an indigenous plant in Gabon, the
Democratic Republic of the Congo, and the Republic of the Congo.
Its root bark contains the psychoactive substance ibogaine, an
indole alkaloid that “packs a serious psychedelic wallop” and
reportedly acts on the brain “like a hybrid of PCP and LSD”.

The cover story of this month titled: “Pharmaceutical Roots:
‘Breaking open the head’ with ibogaine hydrochloride” contributed
by LGC Mikromol. Although ibogaine has been illegal in the US since
1967, both anecdotal reports and research studies suggest it is a
highly promising candidate as a treatment for addiction. For
example, one small, year-long study in New Zealand reported
significant success in keeping opioid-dependent participants off
drugs. Meanwhile, a programme that treated 51 US combat veterans
for trauma-related psychological and cognitive impairment with
ibogaine and 5-methoxy-N, N-dimethyltryptamine reported
“significant and very large reductions” in a range of symptoms,
including depression and post-traumatic stress disorder (PTSD).

The edition has a featured article entitled “Speeding up
development of a hypoallergenic haircare formulation”
contributed by Asynt.
To tackle common scalp issues encountered by patients, a tricology
clinic had been developing scalp therapy products in collaboration
with formulation laboratories and manufacturers. However, with
multiple active and incompatible ingredients, the formulations
created were often unstable. Here2Grow was approached to tackle
the issues through the creation of an effective shampoo and
conditioner with hypoallergenic properties. Dr Henry Brew, CEO of
Here2Grow commented “The formulation challenge posed by the
tricology clinic required us to prepare a hair care product which
involved a specific mixing, heating, and processing regime.

Dear subscribers, we could not imagine anything better than to have
your essential criticism and proposals since they help us to concoct
much better material each time. For any suggestion and feedback
please feel free to write: [email protected]

Disclaimer: Microbioz India, September 2022 | 8
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creating, producing or delivering the Microbioz India (in printed, web or CD
format) or the materials contained therein, assumes any liability or responsibility
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arising out of the use of the Microbioz India magazine.

Microbioz India, September 2022 | 9

Cover Story

Pharmaceutical Roots: ‘Breaking open the

head’ with ibogaine hydrochloride

Pharmaceutical roots are a content series from LGC Mikromol investigating and outlining
the natural origins of pharmaceutical substances, and offering a deeper dive into their
uses, risks, and mechanisms of action.

Introduction Although ibogaine has been illegal in the US since
1967, both anecdotal reports and research
Tabernanthe iboga (iboga) is an indigenous plant in studies suggest it is a highly promising candidate
Gabon, the Democratic Republic of the Congo, as a treatment for addiction. For example, one
and the Republic of the Congo. Its root bark small, year-long study in New Zealand
contains the psychoactive substance ibogaine, an reported significant success in keeping opioid-
indole alkaloid that “packs a serious psychedelic dependent participants off drugs.
wallop” and reportedly acts on the brain “like a
hybrid of PCP and LSD”.

Microbioz India, September 2022 | 10

Cover Story

Meanwhile, a programme that treated 51 US
combat veterans for trauma-related psychological
and cognitive impairment with ibogaine and 5-
methoxy-N,N-dimethyltryptamine reported
“significant and very large reductions” in a
range of symptoms, including depression
and post-traumatic stress disorder (PTSD).

ibogaine for treatment

Some countries, including the UK, Canada, During the 1950s, The US Central Intelligence
and Mexico, allow ibogaine to be prescribed by Agency (CIA) reportedly carried out secret
clinicians to treat addiction, while there research on the effects of the drug – using
is increasing interest from researchers in opioid-dependent people sentenced to mandatory
developing the compound and its analogues to rehabilitation at a hospital in Lexington,
treat opioid dependence and a range of mental Kentucky. The experiments were allegedly part
health conditions on a large scale. of the CIA’s notorious MK-ULTRA
programme that tried to find “a mind control
History drug that could be weaponised against enemies”.

Extracts from the iboga shrub have traditionally More peaceable researchers led by former heroin
been used in healing rituals and initiation addict Howard Lots of later launched a series of
ceremonies by followers of the Bwiti religion in clinical trials aimed at investigating ibogaine’s
west Africa. Around the turn of the 20th century, ability to cure opioid addiction. Lots of, who in
the scientists Dybowski and 1962 had experimented with ibogaine and
Landrin observed canoeists and other discovered that it suddenly “wiped out” his
inhabitants of the French Congo using the plant addiction, found that seven other heroin addicts
as a stimulant, noting: “They claim that absorbing also had the same experience after taking ibogaine
a certain quantity of the plant will give renewed during ‘lay’ drug trials that he organised. During
strength and make it possible to withstand fatigue the 1980s, Lots of worked with a Belgian
for a long time, doing away with any need for company to produce a tablet form of ibogaine for
sleep”. Dybowski and Landrin became the first to placebo-controlled clinical trials, which
isolate ibogaine in 1901, and before being demonstrated attenuation of opioid
outlawed in the 1960s, it was sold in France as withdrawal in rats. Later studies showed that
an antidepressant and stimulant called ibogaine was also apparently effective in
Lambarene. reducing cocaine and alcohol dependence in
rats, while a phase I human trial also showed that
25 out of 33 heroin addicts treated with the drug
“showed improvements in their symptoms
of opioid withdrawal.”

Risks and complications of use Ibogaine’s
growing reputation as a potential treatment for
serious addiction, coupled with its continued
illegality, has led to the emergence of a dangerous
market in underground therapy.

Microbioz India, September 2022 | 11

Cover Story

According to an article in Village Voice, at least Outlook
19 people died between 1991 and 2013 while Interest in studying ibogaine suffered something
undergoing such treatments – “almost always of a lull after 1995, when the US National
when combining the hallucinogen with other Institutes of Health cancelled its research
drugs.” But, even for those that survive, taking programme into it. But new companies have
ibogaine in an unauthorised setting can be recently sprung up in the hope of developing
extremely unpleasant. Bwiti practitioners describe commercially viable ibogaine treatments, as well
the ‘trip’ as like “breaking open the head”, as designing new analogues that could cure
while other dangerous side effects include intense addiction without the ‘trip’ associated with the
nausea and heart arrhythmia. drug.
The atai subsidiary DemeRx is
ibogaine currently conducting phase I/IIa clinical
trials in the UK to assess the safety, tolerability,
Modern-day ibogaine researchers are, however, pharmacokinetics and efficacy of ibogaine, with
confident that such side-effects can be initial data expected this year. However, atai is
safely managed in controlled laboratory also studying the potential of noribogaine,
settings, with proper medical support. ibogaine’s principal psychoactive metabolite,
because it does not produce hallucinogenic
According to Dr Srinivas Rao, chief scientific effects and therefore may be suitable as
officer at drug developers atai Life Sciences, ‘maintenance therapy’ that could be taken in an
careful dosing and further trials should in office or home setting.
particular lessen the cardiovascular dangers
that, traditionally, have been associated with Meanwhile, David Olson, a chemistry and
ibogaine use. Rao also argues that – with neuroscience professor at the University of
America in the grip of an opioid crisis – finding California, is looking to develop non-
an effective addiction treatment would probably psychoactive analogues of compounds like
justify some level of cardiovascular risk. ibogaine as treatments for substance abuse,
depression and dementia.
Mechanism of action

Ibogaine is obtained by extraction from the iboga His modified ibogaine molecule, Delix-7, has
plant, or by semi-synthesis from attracted the interest of the US National Institute
voacangine, another plant alkaloid. It is highly of Drug Abuse, as well as considerable funding
lipophilic and subject to extensive from commercial investors.
biotransformation, primarily by the cytochrome Designed to stimulate neuroplasticity in the brain
P450 (CYP450) 2D6 enzyme. It disappears fairly via the 5-HT-2A receptor, Olson’s so-called
rapidly from the bloodstream, with a half-life of ‘psychoplastogens’ are currently scheduled for
7.5 hours. Ibogaine and its analogues act on clinical trials at the end of 2022.
several neurotransmitter systems in the brain that
may contribute to the ability to suppress
autonomic changes, objective signs, and
subjective distress associated with opiate
withdrawal. It binds to numerous sites in the
central nervous system, including serotonin,
dopamine, and sigma receptors, kappa- and mu-
opioid receptors, and the n-methyl-d-aspartate
ion channel.

Microbioz India, September 2022 | 12

Cover Story

After four decades of being regarded as About Mikromol:
dangerous or subversive, psychoactive
compounds including MDMA, LSD and For more than 28 years, Mikromol™ reference
psilocybin are now firmly in the mainstream of standards have been produced to the highest
pharmaceutical research, with 17 clinical trials quality, to provide you with the reliable quality
of psychedelic drugs listed as ongoing in 2020. control and validation materials you need. Today
Ibogaine, with its long-held reputation as a the majority of analytical measurements are
powerful therapeutic, now also seems ready for its performed under our ISO/IEC 17025 scope of
own ‘moment’, and could yet provide the basis of accreditation and a leading range of products are
tomorrow’s treatments for addiction and mental manufactured according to our ISO 17034
disorders. accreditation. In our range of more than 6,000
pharmaceutical API, impurity and excipient
To support your analysis and help ensure the reference standards, each comes with a
accuracy of your quality control processes, we comprehensive Certificate of Analysis detailing the
supply an ISO 17034-accredited LGC Mikromol API characterisation process for the material, and
standard for ibogaine hydrochloride. ensuring its suitability for both qualitative and
quantitative analysis.
For more in the extensive Mikromol range of quality
API, impurity and excipient reference standards for
the pharmaceutical industry, explore our full range.

Microbioz India, September 2022 | 13

Featured Article

Speeding up development of a
hypoallergenic haircare formulation

Asynt report how award-winning
formulation and development lab –
Here2Grow Cosmetics & Homecare
Labs (Selby, UK) used the ReactoMate
DATUM laboratory reaction vessel system in the
development of a next generation clinical haircare
product.

To tackle common scalp issues encountered by
patients, a tricology clinic had been developing scalp
therapy products in collaboration with formulation
laboratories and manufacturers. However, with
multiple active and incompatible ingredients, the
formulations created were often unstable.
Here2Grow was approached to tackle the issues
through the creation of an effective shampoo and
conditioner with hypoallergenic properties.

Dr Henry Brew, CEO of Here2Grow Dr Henry Brew of Here2Grow Cosmetics & Homecare
commented “The formulation challenge posed by Labs, with the Asynt ReactoMate DATUM
the tricology clinic required us to prepare a hair care
product which involved a specific mixing, heating,
and processing regime. By using the ReactoMate
DATUM we were able to not only improve the
formulation process and meet the specifications of
the new product in a repeatable and consistent
manner, but also save our company time and
money.”

He added “Throughout the haircare product ReactoMate DATUM with Julabo temperature
formulation and development process we found the control unit
Asynt development team were knowledgeable,
friendly, and responsive, helping us meet our For further information on this formulation
deadlines. Beyond this specific project, we are using
the ReactoMate Datum and laboratory reaction development project please visit
vessels from Asynt with a range of other apparatus
to trial scale-up formulations, design formulation www.asynt.com/asyntise-your-lab/custom-
processes and perform fundamental research on
various liquid materials and ingredients we are reactors/next-generation-clinical-haircare-product/
looking to integrate into formulated commercial
products.” or contact Asynt on +44-1638-781709 /

Through the trialling of multiple prototypes, a stable mailto:[email protected].
formulation was produced which significantly
reduced dandruff, itching, and fungal activity.
Here2Grow’s success at developing a
hypoallergenic shampoo and conditioner has made
a valuable step forward in the improvement of scalp
care products.

Microbioz India, September 2022 | 14

Featured Article

With clients ranging from global FMCG companies, Quick changeover between reactor vessel sizes
to leading boutique organisations, Here2Grow enables simple reaction scale-up, whilst the
Cosmetics & Homecare Labs ingenious mounting mechanism ensures excellent
(www.here2grow.com) provide bespoke stability and alignment every time. The ReactoMate
formulation services, ensuring that clients can get DATUM is fully compatible with all leading brands
the best market positioning to optimise their of overhead stirrers and circulator heating/cooling
product development aspirations. The company systems, making it flexible to suit your lab.
assists with innovative ideation, development and
manufacturing of products and has a growing Asynt is a leading supplier of chemistry equipment
portfolio in personal care, home care, detergents for scientists in industry and academia. With a sales
and dish wash technology and green technologies. team of trained chemists, Asynt draw upon their in-
depth application knowledge to provide a high-level
Sturdy, yet compact, the ReactoMate DATUM of customer support for its oil-free DrySyn Heating
support system from Asynt is proven to enhance Blocks, CondenSyn waterless condensers, turn-key
the stability and safety of your lab reactor and can & bespoke solutions for Controlled Lab Reactors,
accommodate a wide range of reaction vessels from Flow Chemistry apparatus, Photochemistry
100 mL up to 5,000 mL. Changing a vessel systems, Synthesis Tools, Evaporators,
supported by the ReactoMate DATUM is as simple Temperature Control Systems, Vacuum Pumps and
as “Clip & Click” thanks to the novel neck clamp. Lab Safety Equipment plus more.

For more information please contact:

Media: Dr Bill Bradbury +44-

208-546-0869 / [email protected]

Microbioz India, September 2022 | 15

Featured Article

New Monodisperse Fully Porous Particles

(MFPP) For HPLC

The move from irregular silica to spherical silica, the decrease in particle size from >5um in
HPLC to sub 2um particles in UHPLC, the improved silica purity of type B silica over that of
type A silica, and more recently the adoption of superficially porous particles versus
traditional fully porous particles.

Introduction Subsequent SEM imagery of the Evosphere®
There are many developments in the silica particles particles in comparison with traditional particles
used in liquid chromatography that have been well highlights the much narrower size distribution
documented over the years. The move from (figure 1).
irregular silica to spherical silica, the decrease in Particle Size Measurement
particle size from >5um in HPLC to sub 2um
particles in UHPLC, the improved silica purity of The silica particle size and distribution were
type B silica over that of type A silica, and more measured using a Coulter Multisizer 3 along with
recently the adoption of superficially porous samples from two different commercial 3um silicas.
particles versus traditional fully porous particles. As can be seen in figure 2 both commercial silicas
One area of development that has been discussed have a much broader size distribution than the new
less and is still open to debate is the particle size monodisperse material, with one having a slightly
distribution (psd) of these chromatographic smaller mean particle size and the other a slightly
materials. In this article we discuss the move larger mean particle size.
towards improved monodispersity of silica particles
for the use in high performance liquid
chromatography (HPLC) and how the use of more
monodisperse stationary phases can impact the
resulting chromatographic parameters such as
column efficiency.

Particle Morphology

Using a modified Stober manufacturing process we D90/10 Measurement
have produced silica particles that have an extremely When assigning a measurement to characterise a
high degree of monodispersity with a uniform particle size distribution the ratio of D90/10 is often
smooth surface. Monodispersity generates high quoted, and as such can be used to gauge the degree
efficiency HPLC columns due to the reduced flow of size uniformity of the particles. The parameter
path dispersion (Eddy diffusion). D90 signifies the point in the size distribution, up to
and including which, 90% of the total volume of
material in the sample is ‘contained’. For example; if
the D90 is 6µm, this means that 90% of the sample
has size of 6µm or smaller. The definition for D50,
is then the size point below which 50% of the
material is contained.
Similarly, the D10 is the size below which 10% of
the material is contained. This description has long
been used in size distribution measurements.

Microbioz India, September 2022 | 16

Featured Article

As the particle size distribution for
chromatographic silica moves towards
monodisperse then the D90 and D10 values
become closer together and the D90/10 value tends
towards a value of 1.
Column Backpressure

When we then studied the column backpressure of
columns packed under identical conditions
containing these three different silicas (figure 3), we
could see that although the mean particle size affects
the resulting backpressure the degree of
monodispersity (d90/10) does not.
Efficiency Gains

This performance is generated due to the low Eddy
diffusion (A-term) coupled with rapid mass transfer
(C-term).
When we compare SPP efficiencies with those of
MFPP, that have a similar Eddy diffusion, we can
see that for the first time fully porous particles can
perform to a similar level as SPP (see figure 6).

The efficiency of columns packed with the new Another consideration when looking to move a
monodisperse particles were then compared against chromatographic method from the laboratory to the
a number of existing commercial (nomonodisperse) production facility is the cost and availability of the
columns and the results can be seen in figures 4 and materials involved. Due to the processing costs of
5. SPP these materials can be prohibitively expensive
or not available to the customer in larger scale.
SPP (Core-shell) versus MFPP Whereas the MFPP discussed in this poster are fully
The recent adoption of superficially porous particles scalable and produced at traditional cost levels.
(SPP) in HPLC has been mostly due to the high Conclusion
column efficiencies achievable without generating Our new silica particles have been manufactured to
the high backpressures that require UHPLC provide a high degree of monodispersity with a
instrumentation. uniform smooth surface. Monodispersity generates
high efficiency HPLC columns due to the reduced
flow path dispersion (Eddy diffusion). SEM
imagery of the Evosphere® in comparison with
traditional particles highlights the much narrower
size distribution. Combining this monodisperse
particle with a range of surface chemistries can
provide the ultimate in terms of sample resolution
and sensitivity when developing new and improved
HPLC methods.

Microbioz India, September 2022 | 17

Featured Article

HiMedia Launches Monkeypox RT PCR
and Viral DNA Extraction kits

HiMedia Laboratories is geared up to face a After capturing the global market with its complete
possible outbreak of Monkey pox Virus portfolio of COVID testing products, the RnD
with Extraction and RTPCR Detection team has developed kits for Monkey pox testing that
Kits. is in the process of receiving ICMR validation.
Running ahead of time, HiGenoMB®, the These kits are available for research use right now.
Molecular Biology section of HiMedia Labs is
prepared for what can become the next pandemic – “Dr. Rajas V Warke – Director, Virology
Monkeypox. It is amongst the first few Indian multi
nationals to come up with the Viral DNA and Molecular Biology, Himedia
Extraction and Monkeypox RTPCR Kits for Laboratories, says “Being ahead of
detection of the virus. time in terms of molecular diagnostic
Swab samples from suspected individuals can be needs explains our preparedness for
processed using HiPurA® Viral DNA/RNA the challenging times in future. Our
Purification Kit (MB582) that is based on the silica team strives to ensure that the country
column format and aids in quick and simultaneous would always be self-reliant in terms
extraction of the viral DNA and RNA from the of Molecular Detection kits.”
sample.

Subsequent detection by HiPurA® Monkeypox Please visit our website www.himedialabs.com for
Virus Multiplex Probe PCR Kit (MBPCR269), a more details about HiGenoMB® products related
Taq Man based Probe PCR kit that can accurately COVID Molecular testing.
detect the virus with utmost sensitivity and About HiMedia Laboratories Pvt. Ltd.
specificity; even 3.31 copies/µl of the viral gene. HiMedia is one of the largest Indian Biosciences
The overall time required for the Molecular Test is company, providing solutions to over 150 countries
approximately 90 minutes. worldwide with an all-inclusive product range
catering to Microbiology, Molecular Biology,
Animal Cell culture, Plant Tissue culture, Bio
chemicals, Laboratory Aids, Molecular Diagnostic
instruments and more. HiGenoMB® encompasses
the Molecular Biology Product Range of HiMedia
Laboratories Pvt. Ltd. Comprising of DNA/RNA
Extraction kits, PCR reagents, NASBA (Nucleic
Acid Sequence Based Amplification tests),
Proteomics, Molecular biology grade chemicals and
buffers and Instrumentation for Research &
Diagnostics. HiGenoMB® has now ventured into
service industry with its Hi-Gx360TM services
offering a complete portfolio of Sequencing &
Bioinformatics solutions in diverse areas. Covering
major aspects of the most dynamic branches of the
Life Sciences group, HiGenoMB® team strives
hard to make molecular work enjoyable with its
user-friendly product range.

Microbioz India, September 2022 | 18

Microbioz India, September 2022 | 19

Featured Article

SMART and NTU Singapore develop a quick test
kit to determine a person’s immunity against
COVID-19 and its variants

A team of scientists from
the Singapore-MIT
Alliance for Research and
Technology (SMART), MIT’s

research enterprise in Singapore,

and Nanyang Technological

University, Singapore (NTU

Singapore) has developed a quick

test kit that can tell if a person has

immunity against COVID-19 and

its variants, based on the

antibodies detected in a blood

sample.

Different from ART test kits –

which look for the presence of

viral proteins produced during a

COVID-19 infection to

determine if a person is infected – (from left) Patrina Chua (SMART), Professor Peter
Preiser (NTU/SMART), Dr Megan McBee
this rapid point-of-care test kit is a serology test that (SMART), Abirami R. (SMART), Say Yong Ng
(SMART), and Sharon Ling (SMART). Dr McBee
measures antibodies made by the patient. It requires and Abirami are holding the test kit cartridge and
the reagents required for the rapid detection of
a drop of blood and takes just 10 minutes to show COVID-19 neutralising antibodies.

results, as compared to the 24 to 72 hours required The work is funded by the National Research
Foundation (NRF) Singapore under its Campus
for conventional laboratory testing. for Research Excellence and Technological
Enterprise (CREATE) programme. It is also
The test kit detects the levels of neutralising supported by Singapore’s National Medical
Research Council (NMRC), under its COVID-19
antibodies against SARS-COV-2, the virus causing Research Fund, and National Health Innovation
Centre (NHIC), under its COVID-19 Gap
COVID-19, and its variants such as Delta and funding grant.

Omicron, and can be easily adapted for new variants Fast and accurate tests to overcome challenges
Having an accurate and rapid serology test can
of concern and other diseases in the future. enable governments and healthcare organisations to
effectively manage limited vaccine resources, and
Using a paper-based assay that is coated with address vaccine hesitancy, particularly concerning
multiple booster doses.
chemicals that bind to antibodies in the blood Vaccination has been an integral component of
public health strategies to tackle the COVID-19
sample, the test kit is low-cost, fast and has up to 93 pandemic, with 12.6 billion doses across 184
countries[2] administered as of 9 Sep 2022.
per cent accuracy. It paves the way for personalised

vaccination strategies, where people are only given

vaccinations and booster shots when necessary,

depending on their variance in antibody levels and

immune response.

The findings[1] were published in the scientific

journal Microbiology Spectrum by the joint team led

by SMART’s Antimicrobial Resistance (AMR)

Interdisciplinary Research Group

(IRG) and NTU’s School of Biological

Sciences, in collaboration with Singapore’s

National University Hospital

(NUH) and National Centre for Infectious

Diseases (NCID), and Massachusetts Institute

of Technology (MIT).

Microbioz India, September 2022 | 20

Featured Article

Vaccines reduced the COVID-19 death toll by 63 Corresponding author of the paper, Professor
per cent within the first year of their rollout, Peter Preiser, Co-Lead Principal Investigator at
preventing an estimated 19.8 million deaths SMART AMR and Associate Vice President for
worldwide, according to a report[3] by the World Biomedical and Life Sciences at NTU
Health Organisation (WHO). Singapore said: “Our team’s work in the
In Singapore, the Ministry of Health (MOH) development of a rapid test kit has given us valuable
estimated in February 2022 that COVID-19 insights into vaccine effectiveness and protection
vaccines had prevented 8,000 deaths[4] during the longevity. Our study proves that our new test kit can
wave of the Delta variant in 2021, as well as be a powerful tool, allowing healthcare
preventing an estimated 33,000 severe cases and organisations to screen people and determine their
112,000 hospitalisations. vaccination needs, especially against the current and
However, a clinical study by the joint research team upcoming variants. This will help allay some
has shown that the protection offered by currently people’s fears that they will be ‘over-vaccinated with
available vaccines steadily declines over three a booster’, since the results will inform them
months, with varying degrees of decline across accurately if they are well-protected against
individuals. The study showed that after three COVID-19 or not.”
months of a booster shot, the neutralising antibody Dr Hadley Sikes, SMART AMR Principal
(NAb) response against wildtype and Delta still Investigator, Associate Professor at MIT and
remained high at medians of 91.8 per cent, while co-corresponding author of the paper added, “Over
medians against Beta and Gamma had dropped to the course of the pandemic, several large studies
82.7 and for Omicron, a large drop to 70.7 per cent, have shown that NAb levels against the dominant
down from 92.9 per cent. variant at the time of the study are a reliable
The emergence of novel variants with much higher indicator of protection from infection. Some
transmissibility than the wild-type virus – such as segments of the population have low tolerance for
Delta and Omicron – has exacerbated the issue of risk of infection. The test kit we developed can
using mRNA vaccines developed based on the provide valuable, individualised information about
wildtype virus to boost immunity, especially when how quickly or how slowly a person’s antibodies
some current vaccines are showing reduced levels have fallen, allowing them to stay informed of
protection against these novel variants of concern their health and, whenever required, get a necessary
(VoC). booster dose to protect themselves.”
In addition, vaccine hesitancy remains among Proven effectiveness of antibody test kit
limited subsets of the population, where people are In their research paper, the team describes a clinical
wary of taking the vaccine or booster shots due to study of their cellulose pulled-down virus
fear of side effects, further compounding the neutralisation test kit (cpVNT), a neutralising
difficulty in employing a widespread vaccination antibody blood test designed to assess an
strategy to build herd immunity. individual’s immunoprotective profile against
To address vaccine hesitancy and efficacy of SARS-CoV-2 and its variants.
vaccination against novel variants, a personalised With a drop of finger prick blood, the test kit can
vaccination approach could be more effective, one evaluate an individual’s neutralising antibody level
which offers booster doses to individuals assessed against a specific COVID-19 variant within 10
to be more at risk, such as healthcare workers and minutes, making this an efficient, low-cost, and
the elderly. easy-to-use tool that will enable large-scale testing
For a personalised approach to be effective, and can be widely deployed anywhere as part of a
healthcare workers need to be able to quickly personalised vaccination strategy.
evaluate the level of NAb response against variants
at the individual level, using an easy-to-use point-of-
care test kit in clinics, hospitals or vaccination
centres.

Microbioz India, September 2022 | 21

Featured Article

COVID-19 antibodies test kits (right) and the digital Individuals from these communities can have their
reader device (left in black), which can detect levels immuno-protective profile assessed on a regular
of COVID-19 antibodies from a drop of blood in basis via the cpVNT, allowing them to know when
just ten minutes. a booster dose may be appropriate or necessary.
Furthermore, this test can be easily adapted to test
The test reveals the individual’s level of neutralising for novel SARS-CoV-2 variants that may emerge in
antibodies, which can then inform a person when a the future.”
booster should be taken, and how cautious they A drop of blood from a finger prick can now
should be about potential transmission before it is determine if a booster dose is required
taken. Research shows that vaccine protection wanes
It can be administered by a layperson without over time and immune response in individuals
medical training and does not require any differs
specialised laboratory equipment, paving the way Platform technology can be adapted for new
for large-scale testing of vulnerable subsets of the variants and other diseases in the future
population such as the elderly. This research builds on years-long body of work by
Co-first author of the paper and the SMART team. In a paper[5] published in the
former Postdoctoral Associate at SMART AMR medical and public health journal Communications
Hoi Lok Cheng said, “This is an exciting Medicine, the team laid out the foundation for a
breakthrough for us, and a continuation of our long- cellulose-based vertical-flow test to detect
running work to develop efficient, low-cost, and neutralising antibodies against SARS-CoV-2.
easy-to-use NAb tests to combat the COVID-19 A separate paper[6] published in premier chemical
pandemic. As a quantitative test that can detect engineering journal Bioengineering and Translational
NAb levels specific to key variants such as Delta and Medicine discussed the test’s effectiveness against
Omicron, the cpVNT has given us valuable insights other methods such as the pseudovirus-based virus
into the effectiveness of various vaccines vis-à-vis neutralisation test (pVNT) and surrogate virus
variants of concern. This test kit will also prove neutralisation test (sVNT), with favourable results.
integral to a more personalised vaccination
approach that will benefit higher-risk individuals
such as the elderly and healthcare workers.

Microbioz India, September 2022 | 22

Featured Article

Using clinical samples (including both whole blood Key development of the rapid test was done at
and plasma) and the World Health Organisation
International Standard and Reference Panel for SMART AMR together with NTU scientists, who
anti-SARS-CoV-2 antibody, the team established
that a whole-blood test such as the cpVNT could be helped in the design of the study, providing specific
as informative as a plasma-only test.
As plasma- or serum-based tests require laboratory reagent supplies and clinical sample collections.
equipment to process the blood sample as well as
higher quantities of blood samples to be taken, the NUH and NCID had provided clinical sample
cpVNT is therefore more resource-efficient and less
invasive. supplies and consultation on medical use of the test,
Furthermore, the cpVNT’s viability demonstrates
that neutralising antibody and point-of-care tests while MIT supervised the project.
can be successfully performed using such a format
and protocol – paving the way for further [1] https://journals.asm.org/doi/10.1128/spectru
development and innovation of this platform to
tackle other diseases. m.02257-22
Further development of the test kit is underway to
meet the necessary regulatory approvals and [2] https://www.bloomberg.com/graphics/covid-
manufacturing standards for public use. The team
that has developed the tests at SMART has also vaccine-tracker-global-distribution/
spun off a biotech startup, Thrixen, which is
developing the test into a commercially ready [3] https://www.who.int/news/item/22-07-2022-
product.
who-releases-global-covid-19-vaccination-strategy-

update-to-reach-unprotected

[4] https://www.straitstimes.com/singapore/healt

h/covid-19-vaccines-helped-prevent-8000-deaths-

during-delta-wave-moh

[5] Smart develops 10-minute test for detection of

covid immunity. SMART. (n.d.). Retrieved

September 9, 2022,

from https://smart.mit.edu/news-

events/news/smart-develops-10-minute-test-for-

detection-of-covid-immunity

[6] Lim, SM, Cheng, HL, Jia, H, et al. Finger stick

blood test to assess postvaccination SARS-CoV-2

neutralizing antibody response against

variants. Bioeng Transl

Med. 2022; 7(2):e10293. https://doi.org/10.1002/

btm2.10293

Microbioz India, September 2022 | 23

Featured Article

GMP-compliant products for pre-clinical and
ATMP research

Life science and healthcare specialists – Founded in 1987, AMS Biotechnology (AMSBIO)
AMSBIO reports upon its extensive range of
high quality GMP-compliant products and is recognized today as a leading transatlantic
services for pre-clinical and advanced therapy
medical products (ATMP) research. company contributing to the acceleration of

Good Manufacturing Practice (GMP) is an discovery through the provision of cutting-edge life
internationally recognized system which ensures
that products are consistently manufactured to a science technology, products and services for
high-quality and provides key guidelines for the
manufacture of Advanced Therapy Medicinal research and development in the medical, nutrition,
Products (ATMPs). Operating as an ISO 9001
registered organization - AMSBIO understand the cosmetics, and energy industries. AMSBIO has in-
importance of offering GMP compliant products
and services with guaranteed quality and depth expertise in extracellular matrices to provide
consistency for your pre-clinical and clinical ATMP
research. elegant solutions for studying cell motility,

Visitors to https://www.amsbio.com/gmp- migration, invasion, and proliferation. This
products-services/ can learn about, select and order
from AMSBIO’s extensive range of GMP expertise in cell culture and the ECM allows
compliant cell culture media, recombinant proteins,
dissociation enzymes, cryopreservation, and viral AMSBIO to partner with clients in tailoring cell
gene delivery products. Sourcing from AMSBIO
you can be assured of the consistent, high-quality of systems to enhance organoid and spheroid
their GMP-compliant materials and in your supply
chain. Critically to ensure the traceability of all their screening outcomes using a variety of 3D culture
GMP compliant products – AMSBIO can also
supply associated FDA-registered Drug Master systems, including organ-on-a-chip
Files and provide ICH stability study data
supporting enzyme storage and shipping microfluidics. For drug discovery research,
conditions. Drawing upon its experience of serving
pre-clinical and clinical ATMP research, AMSBIO AMSBIO offers assays, recombinant proteins, and
also offers high quality, GMP-compliant custom
product development services for numerous cell lines. Drawing upon a huge and comprehensive
research areas.
biorepository, AMSBIO is widely recognized as a

leading provider of high-quality tissue specimens

(including custom procurement) from both human

and animal tissues. The company provides unique

clinical grade products for stem cell and cell therapy

applications. This includes GMP cryopreservation

technology, and high-quality solutions for viral

delivery (lentivirus, adenovirus, and adeno-

associated virus.

To learn more about AMSBIO GMP compliant

products and services to streamline your clinical

translation please visit

https://www.amsbio.com/gmp-products-

services/ or contact the company on AMSBIO on

+31-72-8080244 / +44-1235-828200 / +1-617- Caption: Human bronchial organoids infected with
SARS-CoV-2 after cryopreservation in STEM-
945-5033 / [email protected]. To learn more CELLBANKER®. Red: acetylated α-tubulin,
green: SARS-CoV-2-N protein, blue: DAPI. Images
about Good Manufacturing Practice – download courtesy of Kazuo Takayama (CiRA, Kyoto
University, Japan)
the AMSBIO ‘Guide to GMP’ from

https://www.amsbio.com/guide-to-gmp/.

Microbioz India, September 2022 | 24

Featured Article

Caption: GMP compliant products and services

GMP grade STEM-CELLBANKER For further Information MEDIA:
cryopreservation media
Dr Bill Bradbury Primetek Solutions

tel. +44-208-546-0869 / email info@primetek-

solutions.com

TECHNICAL: Emma Moth AMSBIO

tel. +44-1235-828200 / email

[email protected]

Microbioz India, September 2022 | 25

Business News

WuXi STA Opens a New Sterile Lipid Nanoparticle
Formulation Facility to Enhance Global CRDMO
Services for Customers

WuXi STA, a subsidiary of WuXi In addition, the modular design provides greater
AppTec, today announced the opening processing flexibility, enabling this platform to
of a new sterile lipid nanoparticle serve a wide range of manufacturing scales from
(LNP) formulation development and 10-50 L per batch.
manufacturing facility at its Wuxi city campus. As a premier Contract Research Development
Created in response to the increasing demand for and Manufacturing Organization (CRDMO),
complex injection dosage forms, this new facility WuXi STA’s integrated drug product platform
adds to the company’s fast-growing parenteral offers a full spectrum of services, including solid-
formulation capabilities and is yet another state development, pre-formulation, formulation
opportunity to enable customers as they develop development, and clinical to commercial drug
and deliver better medicines for patients. product manufacturing with a variety of drug
delivery technologies, including a broad range of
New Lipid Nanoparticle (LNP) Production oral and injectable dosage forms. This new sterile
Facility in Wuxi City, China LNP platform further expands our end-to-end
This new facility integrates multi-channel chip, capabilities.
micro-mixer system, and complex preparation WuXi STA has 12 sites across the
system into a multi-channel micro-mixer core U.S., Europe and Asia that offer a wide range of
LNP manufacturing platform, offering significant services and meet global regulatory standards.
advantages in drug-loading, liposome particle size Together with other development and
control, and encapsulation efficiency. manufacturing sites, this new platform provides
considerable synergy with the company’s
oligonucleotide CRDMO platform. The LNP
delivery system is particularly advantageous in
overcoming the bioavailability challenge of
oligonucleotides and their conjugates.
Dr. Minzhang Chen, Co-CEO of WuXi AppTec
and CEO of WuXi STA, commented, “We are
pleased to support our partners with this state-of-
the-art LNP facility to meet the growing demand
for advanced injection dosage forms. We will
continue to expand our CRDMO platform’s
capacity and capabilities to enable our partners to
accelerate more innovative drugs to market for
patients worldwide.”

Microbioz India, September 2022 | 26

Microbioz India, September 2022 | 27

Business News

Kiran Mazumdar Shaw Awarded It is through our philosophy of affordable innovation that we
with H.K. Firodia Lifetime have been able to make a difference to global health equity by
Achievement Award 2022 for ensuring that no patient anywhere in the world is denied
Excellence in Science & essential and lifesaving biologic drugs on account of
Technology affordability.”

Kiran Mazumdar-Shaw, Executive As the chief guest at the awards ceremony held in
Chairperson of Biocon Ltd. and Biocon
Biologics Ltd., has been awarded the H.K. Pune, Ms Mazumdar-Shaw felicitated two more
Firodia Lifetime Achievement Award 2022 for
Excellence in Science & Technology by leading women in science. She presented the H.K.
the H.K. Firodia Memorial Foundation on the
25th anniversary of the award. Firodia Vijnan Ratna Award to Dr Gagandeep
The H.K. Firodia Awards Selection Committee
unanimously decided to confer the Lifetime Kang, eminent virologist and Professor of
Achievement Award to Ms Mazumdar-Shaw for
her “monumental contributions as a global Microbiology in the Department of Gastrointestinal
leader in biotechnology innovation and
entrepreneurship.” Sciences at the Christian Medical College (CMC) in

On receiving the award, Ms. Kiran Mazumdar- Vellore; and the H.K. Firodia Vijnan Bhushan
Shaw said: “I feel extremely privileged and humbled to be
recognised for my lifetime efforts in building Biocon to be a Award to Dr. Tessy Thomas, distinguished scientist
responsible and empathetic biotech company that is driven by
the purpose of delivering affordable access to essential and Director General, Aeronautical Systems,
medicines. As a scientist, I was inspired by the vision of
creating an organisation that leverages science & technology Defence Research and Development Organisation
to widen access to lifesaving drugs for patients on the lowest
rung of the economic ladder. (DRDO).

The Awards Selection Committee comprised of

distinguished personalities like Dr. R.A. Mashelkar,

Dr. Anil Kakodkar and Dr. Vijay Bhatkar.

The H.K. Firodia Award was instituted in 1996 in

memory of the Late Shri H.K. Firodia, who is

considered the doyen of the Indian automobile

industry. The

awards are given to

eminent Indian

scientists for their

original and world-

class contributions

to any branch of

science or

technology. Former

Indian President

Dr. APJ Abdul

Kalam was the first

recipient of this

award in 1996.

Previous recipients

of the H.K. Firodia

Award include

some of the most

illustrious names in

the field of Science

& Technology in India, including Dr. M. K. Bhan,

Dr. K. Vijay Raghavan, Dr. R. A. Mashelkar, Dr.

Jayant Narlikar, Prof. C.N.R. Rao, Dr. K.

Kasturirangan etc.

Refer to the attached Press Note and pictures for
covering this important moment in your esteemed
publications.

Microbioz India, September 2022 | 28

Business News

Inhalation Sciences signs DissolvIt® has been increasingly recognized in the
IRS contract worth 1.39 inhalation industry as a leading solution for
million SEK with new US generating “IVIVC” data – that is in vitro
respiratory pharma client dissolution and absorption data early on in the drug
development process that closely predicts later-
The current client is a developer of new small stage in vivo data. Such data can significantly reduce
molecule treatments for a wide range of risk and costs early on in drug development.
respiratory diseases including asthma and ISAB’s contract research organization
COPD. The company has chosen to run dissolution Inhalation Research Services (IRS), has signed
tests on a new substance using ISAB’s leading in a new contract worth 1.39 million SEK (130K
vitro lung simulation tool DissolvIt®. Euros) with a US respiratory pharmaceutical
company. The new client has chosen ISAB’s
unique in vitro lung simulation tool
DissolvIt® for its project.
With a growing body of publications like “In
Vitro to ex Vivo/In Vivo Correlation (IVIVC) of
dissolution kinetics from inhaled particulate solutes
using air/blood barrier models” (Journal of Aerosol
Science 2021) there is increasing interest in
DissolvIt’s advanced capabilities.
ISAB CEO Manoush Masarrat: “We are very
pleased to be working with this new US client. This
clearly demonstrates the client’s confidence in our
world-class expertise, and the leading in vitro
capabilities of DissolvIt®. We are delighted to carry
out this research and look forward to this exciting
collaboration.”

Microbioz India, September 2022 | 29

Pharma News

‘Listen to the Future’- Cipla’s Cipla Health’s “Naselin

digital film reinforces its ESG Shubhratri, Prajapati –

commitments The Guard” campaign

bags “Silver” at Effie

APAC Awards 2022

Cipla Limited launched a thought-provoking Naselin, one of the leading nasal
brand film ‘Listen to the Future’ to reiterate decongestant brands by Cipla Health has
the company’s ESG goals for 2030. To bring swayed the stage away by winning
alive its ethos of contributing toward a greener the “Silver” at the Effie APAC Awards for its
environment and sustainable value creation, the film captivating yet appealing “Naselin Shubhratri,
creatively highlights the importance of positive Prajapati – The Guard” campaign. Naselin becomes
actions through the lens of children. The brand film Cipla’s first ever brand to win a marketing award in
was conceptualized by Cipla’s corporate the Asian Pacific region, which is one of the
communications team and produced by Squirkle industry’s most distinguished accolades for
Productions. marketing effectiveness. APAC Effie Awards are
The three-minute video features children who were globally recognized as the gold standard for agencies
asked a series of questions about climate change, and clients alike.
and actions that need to be taken towards the Naselin has been recognized out of the 29 Indian
conservation of the planet, among others. Through brands and from the total of 107 brands across the
an engaging Q&A session, these children shared Asia Pacific region which is a gratifying moment for
their unfiltered thoughts on actions that are the brand. The award winning TVC ‘Shubhratri,
disrupting our environment and deteriorating Prajapati – The Guard” campaign underlines the
ecosystems on the planet and the measures they significance of choosing the appropriate product by
would take to safeguard our planet. Aptly narrating an anecdote of a watchman who has sleep
titled ‘Listen to the Future’, the video captures deprivation triggered by nasal congestion and
voices of the future generation and seeks our struggles to get a good night’s sleep. Naselin’s
attention to take collective measures to combat decongestant nasal spray aids in relieving him from
severe natural resource and environmental the discomfort of a blocked nose, thus ensuring a
challenges. peaceful sleep.
Over the last 86 years, People, Planet and Purpose Cipla Health Ltd understands the need of our
has remained core to Cipla’s existence and the consumers and believes in prioritizing the consumer
Company has set ambitious sustainability targets to requirements and aims to provide the best-in-class
create lasting positive impact for the world and for offerings. Additionally, Naselin’s Nasal
the business. Through the brand film, the company Decongestant spray contains Oxymetazoline
also reiterated its 2030 sustainability goals to be Hydrochloride which aids in fast relief from clogged
Carbon Positive, Water Positive and AMR nose and sinus congestion and so offers relief over
Compliant. a larger area.

Microbioz India, September 2022 | 30

Microbioz India, September 2022 | 31

Pharma News

Speaking on the win, Shivam Puri, CEO – Cipla According to IQVIA (IMS Health),
Health says, “I am truly pleased and humbled by this Revlimid® (Lenalidomide) Capsules had US sales of
recognition being bestowed on Cipla Health. These approximately $ 2.58 billion for the 12-month
awards are a reflection of our purposeful strides and period ending June 2022.
our relentless commitment to address the unmet
needs of our consumers. Driven by deep consumer Alembic Pharmaceuticals
insights and marketing expertise, Cipla Health has receives USFDA Final
always strived to enhance the lives of our consumers Approval for Chlorthalidone
with the most innovative and effective solutions.” Tablets USP, 25 mg and 50
mg.
Cipla receives USFDA

approval for generic version of

Revlimid® (lenalidomide

capsules)

Cipla Limited (BSE: 500087; NSE: CIPLA Alembic Pharmaceuticals Limited (Alembic)
EQ) (“Cipla”) announced that it has today announced that it has received final
received final approval for its Abbreviated approval from the US Food & Drug
New Drug Application (ANDA) for Lenalidomide Administration (USFDA) for its Abbreviated New
Capsule 5 mg, 10 mg, 15 mg and 25 mg from the Drug Application (ANDA) for Chlorthalidone Tablets
United States Food and Drug Administration (US USP, 25 mg and 50 mg. The approved ANDA is
FDA). therapeutically equivalent to the reference listed drug
Cipla’s Lenalidomide Capsules are the AB-rated product (RLD), Hygroton Tablets, 25 mg and 50 mg,
therapeutic equivalent generic version of Bristol of Sanofi Aventis US LLC (Sanofi). Diuretics such as
Myers Squibb’s (Celgene) Revlimid® (Lenalidomide) chlorthalidone are indicated in the management of
Capsules. hypertension either as the sole therapeutic agent or to
Lenalidomide is an immunomodulatory enhance the effect of other antihypertensive drugs in
prescription drug which is indicated for several the more severe forms of hypertension.
hematological malignancies in adults such as Chlorthalidone is indicated as adjunctive therapy in
Multiple Myeloma, Myelodysplastic syndromes, edema associated with congestive heart failure, hepatic
Mantle cell lymphoma, Follicular lymphoma, and cirrhosis, and corticosteroid and estrogen therapy.
Marginal Zone lymphoma. Depending on the type Chlorthalidone has also been found useful in edema
of cancer, it can be used as monotherapy or due to various forms of renal dysfunction, such as
combination as a part of first line regimen, nephrotic syndrome, acute glomerulonephritis, and
maintenance regimen or relapsed settings. chronic renal failure.
Lenalidomide capsules are not to be used by Chlorthalidone Tablets USP, 25 mg and 50 mg, have
pregnant women. It is not known if lenalidomide is an estimated market size of US$ 37 million for twelve
safe and effective for children. Lenalidomide months ending June, 2022 according to IQVIA.
Capsules should not be used to treat people with Alembic has a cumulative total of 171 ANDA
chronic lymphocytic leukemia (CLL) outside of a approvals (147 final approvals and 24 tentative
controlled clinical trial. approvals) from USFDA.

Microbioz India, September 2022 | 32

Microbioz India, September 2022 | 33

Pharma News

Govt forms committee to The code is not enforceable under any law/statute
of the government, the office memorandum read.
regulate marketing The Indian Medical Council (Professional Conduct,
Etiquette and Ethics) Regulations, 2002, under the
practices of pharma Indian Medical Council Act, 1956, as amended from
time to time, mention in detail the relationship of
companies the healthcare professionals with pharmaceutical
companies and prohibits the physicians and medical
The government has constituted a high-level practitioners from committing such acts which are
committee to hammer out a legal mechanism “unethical” in nature, the office memorandum
to address the issue of pharmaceutical stated.
companies giving inducements for promoting their
Valuebound enables
drugs and products. The five-member committee
chaired by Dr VK Paul, NITI Aayog member pharma and healthcare

(health) will also review various other issues Digital transformation
pertaining to the Uniform Code of Pharmaceutical

Marketing Practices (UCPMP).

The panel includes secretary of the department of Valuebound, a digital experience company in
pharmaceuticals S Aparna, Union health secretary India, strengthened its digital
Rajesh Bhushan, and Central Board of Direct Taxes transformation capabilities by partnering
(CBDT) chairman Nitin Gupta as members, and a with leading pharmaceutical, life sciences, and
joint secretary (policy) from the department of healthcare firms.
pharmaceuticals as member secretary. The With rapid adoption of new age technologies across
committee was constituted on the recommendation pharma and healthcare value chain during the last
of Union Minister of Health and Family Welfare, few years ranging from drug development, patient
Chemicals and Fertilizers, Mansukh Mandaviya. An care to marketing the products, Valuebound saw
office memorandum issued on September 12 stated great demand in development of innovative and
that the department of pharmaceuticals has also put customized digital solutions.
in place a code of ethics, the UCPMP, for pharma Clarivate and Eversana signed up as clients
companies, which has been in effect since January Clarivate, global analytics leader, serves the life
1, 2015 and has been adopted by all the major sciences and pharma sector through its healthcare
pharmaceutical associations. business insights™ and Medtech Intelligence™
The code provides for the procedure of filing units. Clarivate has selected Valuebound Consulting
complaints, inquiry by the Apex Committees of the to power their product information management
Associations, penal actions, etc to be taken by the (PIM), and digital asset management (DAM)
pharma association of which the company is a solutions.
member. Eversana, leading global commercial services
provider to the life sciences industry, engaged
Valuebound to develop a collaborative content
management platform for interactive multi-
format, multi device report creation.
Through these partnerships, Valuebound offered a
perfect solution for transforming unstructured,
disorganized databases into an automated,
interoperable, and intelligent platform.

Microbioz India, September 2022 | 34

Pharma News Lupin gets USFDA nod

The platforms are integrated with other analytics for generic drug
and reporting tools like tableau and support custom
template creation in various formats, which enables Drug firm Lupin on Thursday said it has
end users to seamlessly communicate with each received an approval from the US health
other while contributing for the content creation regulator to market a generic non-steroidal
with complete control over the entire process. anti-inflammatory drug in the American market.
Valuebound offered agile project management, The company has received an approval from the US
dynamic systems development, and extreme project Food and Drug Administration for Diclofenac
management for developing the solutions. Sodium Topical Solution, Lupin said in a statement.
Valuebound also engaged in developing a learning
management solution for a leading pharma
company. The platform offered a scalable solution
used right now by users across the globe.

Piyush Sharma, Chief Technology Officer of The company's product is a generic equivalent of
Valuebound, said, "The siloed information in Horizon Pharma's Pennsaid Topical Solution, it
various repositories throughout the organization added.
causes redundancy of data, applications, processes,
and infrastructure across the activities of drug U.S. FDA asks
development, testing, and finally commercialization. Panacea Biotec to
This in-effect has a negative impact because it
increases costs, decreases productivity and reduces take corrective
agility of business to adopt changes. For larger measures at Himachal
projects with constantly changing requirements, we unit
follow an iterative and incremental project
management approach." He further added that The U.S. Food and Drug Administration
Valuebound's IT solutions help pharmaceutical (USFDA) had inspected the Baddi unit of
clients in mapping complex processes, while also its subsidiary, Panacea Biotec Pharma Ltd.
responding to constantly shifting frameworks. The (PBPL) from May 30 to June 8
security requirements and validation that comes Panacea Biotec Ltd. on Thursday said the U.S.
with such processes, become easy to accomplish health regulator has asked for further corrective
with the consulting, conception, and actions at the manufacturing unit of its wholly-
implementation solutions. owned arm at Baddi in Himachal Pradesh
Technologies used and way forward for Pharma otherwise approval of any pending product
The Pharma and healthcare industry is currently applications from the facility may be withheld.
focused towards upgrading patient and physician
decision-making processes, providing personalized
patient engagement, and managing secure cloud
platforms. Valuebound is working hand in glove
with the leading pharma clients to deliver digital
solutions with latest engineering technologies like
React, React Native, NodeJS, Drupal, MYSQL
database, Redux, MongoDB, along with third-party
integrations with DAM (Nuxeo/ Bynder).
About Valuebound
Valuebound builds digital user experience platforms
that bring technology and people together. It
combines engineering capabilities with a rich legacy
in design and industry expertise to create future-
ready digital products. Valuebound enables
enterprises to drive competitive advantage, with a
focus on modernization, innovation, user
engagement and speed-to-market.
(Disclaimer: The above press release comes to you
under an arrangement with PRNewswire. PTI takes
no editorial responsibility for the same.)

Microbioz India, September 2022 | 35

Pharma News Aurobindo Pharma

The U.S. Food and Drug Administration subsidiary's plant gets
(USFDA) had inspected the Baddi unit of its
subsidiary, Panacea Biotec Pharma Ltd. (PBPL) one observation from
from May 30 to June 8. Subsequently, the
USFDA issued Form 483 with eight observations USFDA
which are related to improvements in existing
procedures and are addressable, Panacea Biotec Aurobindo Pharma said the US health
said in a regulatory filing. regulator has issued one observation after
inspecting a plant owned by its US-based
unit.

According to the U.S. Food and Drug Everstone acquires
Administration (USFDA), Form 483 is issued to
a firm's management at the conclusion of an controlling stake in
inspection when the investigator has observed
any conditions that may constitute violations of Softgel Healthcare
the Food Drug and Cosmetic (FD&C) Act and
related Acts. Singapore-headquartered Everstone Capital,
The company said it has "now received a private equity arm of the Everstone Group,
communication from the USFDA indicating the (Everstone) announces the acquisition of a
inspection classification as Official Action controlling stake in Softgel Healthcare (SHPL), a
Indicated (OAI)". specialized niche dosage form focused
The OAI classification implies that the U.S. FDA manufacturing player catering to the global
expects further corrective actions and may nutraceutical, pharmaceutical and OTC segments.
withhold approval of any pending product This partnership aims to transform SHPL into a
applications or supplements filed from this scaled, diversified, and globally recognized contract
facility till the outstanding observations are research, development, and manufacturing
resolved, it added. organization in India with support of the strategic
"PBPL is working closely with USFDA to close resources of Everstone.
these observations and the closure of the warning Headquartered in Chennai, SHPL is part of the
letter issued by the USFDA earlier on September Madras Pharma Group, a leading pharmaceutical
24, 2020," the filing said. contract manufacturing organization in southern
The warning letter was issued for non-compliance India, with 8 manufacturing facilities covering all
with the current good manufacturing practice dosage forms. SHPL specializes in research,
outlined by the USFDA. development and manufacturing of soft gelatin
It further said PBPL continues to manufacture capsules and probiotics. Its customers span across
and distribute existing products for the U.S. the Americas, Africa, Asia and India with over 80%
market, thereby not likely to have any material of its sales being in exports.
adverse impact on current business from the
facility.

Microbioz India, September 2022 | 36

Microbioz India, September 2022 | 37

Pharma News For more information,
visit www.everstonecapital.com and https://www.l
It has a state-of-the-art manufacturing facility in inkedin.com/company/everstonegroup.
Chennai, conforming to globally recognized For more details, contact:
certifications and registrations such as USFDA, Ayoshmita Biswas
TGA, EU-GMP, Health Canada, among others. [email protected]
Veda Corporate Advisors was the exclusive
financial advisor to SHPL and its shareholders. Cipla's Indore plant
Sharing his views on the investment, Sameer Sain,
Co-founder & CEO, Everstone Group, said, "We gets EIR from
are delighted to partner with SHPL, Mr. Sulaiman
and the management team lead by Dr Vijay USFDA
Alagappan. The company, with its strong R&D
capabilities and ability to manufacture products in The drug major on Thursday announced that
advanced dosage forms, is well positioned to be a it has received the Establishment Inspection
global leader in the CDMO segment. We believe Report (EIR) from the US drug regulator for
that Everstone's value creation playbook will help its Indore plant, indicating closure of the inspection.
SHPL realize its global goals and propel the The company had earlier informed that the United
company into its next phase of growth." States Food and Drug Administration (USFDA) has
conducted a product specific PreApproval
Puncham Mukim and Dr Arjun Oberoi, Managing Inspection (PAI) at the Indore plant from 27 June
Directors, Everstone Capital will join the board of 2022 to 1 July 2022.
SHPL. Cipla is a global pharmaceutical company focused
Mr A. M. Sulaiman, Founder-Chairman of the on agile and sustainable growth, complex generics,
Madras Group, said, "We are delighted to have and deepening portfolio in our home markets of
Everstone as a partner in SHPL as we move ahead India, South Africa, North America, and key
into an exciting growth phase in this business. The regulated and emerging markets.
investment from Everstone will accelerate The company's consolidated net profit slipped 4%
organization learning to provide best-in-class to Rs 686.40 crore on 2.3% decline in total revenue
products and services to our customers and become from operations to Rs 5,375.19 crore in Q1 FY23
a manufacturer of choice." over Q1 FY22.
About SHPL Shares of Cipla were up 0.74% to Rs 1,069.55 on
SHPL is a specialized niche dosage form focused the BSE.
CDMO player servicing the global nutraceutical,
pharmaceutical and OTC segments. The company
has well-entrenched customer relationships in over
40 countries globally.
For more information,
visit https://softgelhealthcare.com and https://w
ww.linkedin.com/company/softgel-healthcare-pvt-
ltd/.
About Everstone Capital
Singapore headquartered Everstone Capital, the
private equity arm of the Everstone Group
(www.everstonegroup.com), is a global firm
committed to driving economic growth and creating
sustainable value. With seven offices globally
(Singapore, Mumbai, Delhi, Bengaluru, New York,
Dubai and Mauritius), Everstone Capital focuses on
the mid-market with control mindset and growth
bias; comprising best of breed investing, operations
and strategic resources with significant experience
and skills.

Microbioz India, September 2022 | 38

Pharma News

USFDA Panel Votes Tuesday that raised concerns over the efficacy of
Against Spectrum's the treatment compared with existing drugs like
Lung Cancer Drug Daiichi Sankyo's and AstraZeneca's Enhertu.
In the documents, the FDA said that given the
The panel's decision was in-line with concerns over dosing, efficacy and delay in
briefing documents released by the drug confirmation of benefit, if the treatment is
regulator on Tuesday that raised concerns granted accelerated approval it would be "the
over the efficacy of the treatment compared with least effective targeted therapy for lung cancer
existing drugs like Daiichi Sankyo's and approved to date.
AstraZeneca's Enhertu. "Clearly there's a clinical unmet need for the drug.
The drug has activity, but I don't know that it has
Advisers to the U.S Food and Drug a meaningful improvement over other drugs that
Administration on Thursday voted against in the real world are available to patients right
recommending Spectrum Pharmaceuticals' now," said Scott Waldman, one of the panel
experimental drug for the treatment of patients members and Chair of Department of
with a form of non-small cell lung cancer. The Pharmacology, Physiology, & Cancer Biology at
FDA panel voted 9 to 4 against the oral drug, Thomas Jefferson University.
poziotinib, citing marginal efficacy, high level of The regulator is expected to make the final
toxicities, and lack of dose optimisation. decision on Spectrum's drug by Nov 24. The
The panel's decision was in-line with briefing FDA is not mandated to follow the advice of its
documents released by the drug regulator on independent experts, but usually does. Spectrum
Chief Executive Officer Tom Riga, in a
statement, expressed disappointment at the
meeting's outcome and said the company plans to
carefully evaluate its options for this program as
it nears the FDA's decision date.
Poziotinib is intended to treat non-small cell lung
cancer (NSCLC) with a rare genetic mutation that
affects 2-4 per cent of total patients with NSCLC.
There is no prior FDA-approved treatment for
the rare lung cancer, and the patients suffering
from the disease are given treatments similar to
those with non-small cell lung cancer without the
mutation.

Microbioz India, September 2022 | 39

Product Showcase

Failsafe monitor to shut off your HPLC if a
solvent reservoir runs dry

The Solvent Line Monitor from TESTA The Solvent Line Monitor is designed to eliminate
Analytical is a true plug-and-play addition this problem, without any user input or need for
to any HPLC system designed to detect regular resetting. The Solvent Line Monitor runs
when one or more of its pump solvent reservoirs independently and is fully compatible with almost
are empty and automatically shut-off the system. any liquid chromatograph.

Modern

chromatography

systems often

include automation

enabling them to

achieve a high

sample throughput

which was

unthinkable just a

few years ago. This

has led to many

organizations

reducing the

number of lab

personnel trained

to run HPLC

systems. Today,

analytical

laboratory staff

typically have to

monitor and

manage several

different

chromatography

systems at the same time. In such a scenario, Solvent Line Monitor being used to monitor an HPLC
pump solvent reservoir
overlooking a small detail such as making sure
The Solvent Line Monitor is purpose designed to
sufficient solvent is available for all runs planned, continuously monitor the fill status of tubing
carrying solvent to up to two liquid chromatography
can easily occur. pumps. It can alert the operator, or even
automatically shut down the operation of an HPLC
Running out of solvent when running an HPLC or System, if no solvent is present in the tubing. The
any other liquid chromatography system is a device operates fully independently from any other
problem most separation scientists will have component and requires no special parameter
encountered. Your chromatograph running out of setting.
solvent can lead to loss of data, need to re-prime the
pump, system downtime and often necessitates re-
validation to make sure the obtained results are
within expected limits.

Microbioz India, September 2022 | 40

Product Showcase

Using the compact and affordable Solvent Line TESTA Analytical Solutions is a leading specialist
Monitor is a straightforward process. The device is
set-up and controlled using an intuitive PC-based supplier of liquid chromatography instruments and
app that provides facility for different actions once
an empty reservoir alarm status is detected, for detectors.
example a simple beep or a stop signal.
For further information on the Solvent Line Drawing upon over 30-years’ experience, TESTA
Monitor please visit https://www.custom-
chromatography.com/technologies.html or contact Analytical Solutions has established itself as a
Testa Analytical Solutions on +49-30-864-24076 /
[email protected]. respected creator and supplier of top quality,

innovative, high performance chromatography

instrument kits, and detectors with OEM clients

around the world.

For Further Information:

Media: Bill Bradbury (tel.

+44-208-546-0869 / email info@primetek-

solutions.com )

Technical: Carlo Dessy (tel.

+49-30-864-24076 / email cdessy@testa-

analytical.com)

Microbioz India, September 2022 | 41

Product Showcase

Standalone Flow Chemistry Module for
Exothermic Reactions

Uniqsis has launched ColdChip™ - a new Since 2007, Uniqsis has specialised in the design and
versatile mixer/reactor module enabling supply of mesoscale continuous flow chemistry
researchers to experiment with different systems for a wide range of applications in chemical
chemistries particularly exothermic reactions that and pharmaceutical research. The company’s aim is
need to be safely run in a cooled environment to make flow chemistry easily accessible to both
with highly efficient mixing. novices and experienced users.

Compact in design, and requiring no input power,
the ColdChip™ is optimised for use with the
Uniqsis FlowSyn and FlowLab range of flow
reactors as well as standalone pumps.

Designed to work with most recirculating
chiller/heater units - the ColdChip™ can deliver a
stable operating temperature (-70ºC to +180 ºC)
and pressure (up to 40 Barr) environment in glass
static mixer chips ranging from lower volumes
(270µl, 1ml or 2 ml) to single residence time chips
(10, 15 and 20 ml). To enhance operator safety and
ease-of-use the ColdChip™ includes a PTFE safety
cover, a glass window to view the glass static mixer
and an open area located at the back for easy access
to the glass static mixer inlet/outlet turret
connectors.

Caption: ColdChip™ mixer/reactor module

For more information please contact:

Media: Dr Bill Bradbury +44-

208-546-0869 / [email protected]

For further information please visit
www.uniqsis.com/ or contact Uniqsis on +44-845-
864-7747 / [email protected].

Microbioz India, September 2022 | 42

Microbioz India, September 2022 | 43

Product Showcase

Fast and simple picking of whole
tissue samples from storage

Ziath announce the launch of the Mohawk Founded in 2005, Ziath specialise in the
48 tube selector and picker. Designed to development of innovative instrumentation control
select and pick wide, heavy, or tall tubes - and information management products using 2D
this new system is perfect for retrieving individual DataMatrix bar-coded tubes to simplify automation
whole tissue samples from storage. processes in life science organisations, from
The Mohawk 48 uses forty-eight solenoid pins to academia to the biotech and pharma industries.
enable a specific frozen or thawed sample tube to
be raised and selected when a 48-position tube rack
is presented according to a pick list from Excel or a
LIMS system. Alternatively, specific individual
tubes can be manually selected and picked via the
user interface. Individual sample tubes can be
picked from a single rack, or users can create a
picklist to select tubes across multiple racks. Pick
lists can be created by connecting the Mohawk to a
Ziath whole-rack reader, such as the Mirage. The
advantage in this case is that destination racks of
picked tubes can also be verified for accuracy on the
same reader. Proven in installations worldwide –
Mohawk tube selection and picking technology
avoids the need for slow and costly robotic systems
– importing a pick list, selecting, and picking larger
whole tissue sample tubes in just seconds.

Caption: Mohawk 48 for retrieving individual
whole tissue samples from storage.

Connecting the Mohawk 48 directly to a 2D- For further Information:
barcode scanner for tube confirmation provides
extra sample tracking and security. Operating in this MEDIA: Dr Bill Bradbury
configuration it is also possible to generate picklists
directly from the tube barcodes. For further Primetek Solutions tel. +44-208-
traceability, a 1D-scanner for reading the rack
barcode is included as standard. 546-0869 / email [email protected]
For further information on the new Mohawk 48
tube selector and picker please visit CORPORATE: Steve Knight Ziath
https://ziath.com/newmohawk48 or contact Ziath
+44-1223-855021 / +31-6 431-41195 / +1-858- Ltd tel. +44-1223-855021 / email
880-6920 / [email protected]
[email protected]

Microbioz India, September 2022 | 44

Product Showcase

Extruded Profiles - (Silicone/Viton®/EPDM)

APPL offers a wide range of Silicone These extruded gaskets are manufactured from fully
Extruded Gaskets in more than 1000 automatic microwave continuous curing system
different shapes and designs (In round and which ensures accurate dimensional properties,
square types). APPL’s extruded gaskets (Autoclave) glossy surface finishes and aesthetically beautiful
are made from Food-Pharma Grade pure silicone colors.
rubber which can easily withstands a temperature Extruded Gaskets can be used in Clean Room
range of -80°C to +250°C. Doors, Telecom Shelters, Air Tight Door Seal
Extruded Gaskets are available in square cross Application, Bakery Ovens, Freeze Doors,
sections like 6mm x 6 mm, 8mm x 8mm, 10mm x Pharmaceuticals Processing Machine’s Doors,
10mm, 20mm x 20mm, 25mm x 25mm etc. with Autoclaves, Isolators, Dry Heat Sterilizers, etc.
OR without hollow. These extruded gaskets are
available in Red, White, Orange or any color as per Ami Polymer Pvt. Ltd.
customer's requirement. Plot No. 66-D/E, Govt. Industrial Estate, Near
Beekaylon Factory, Masat,
Silvassa - 396230. Dadra & Nagar Haveli
Tel.: +91 22 28555 107 / 631 / 914 | Cell: +91
86910 13935
Email: [email protected] |
Web: www.amipolymer.com

Microbioz India, September 2022 | 45

Product Showcase

Research explores new Thermal analysis methods such as
DSC-thermomicroscopy thermomicroscopy allow researchers to closely
approach to reach new observe optical and physical transitions as a material
depths in material property progresses through a reaction or phase change,
analysis ultimately enabling the optimisation of the materials
in their end use. Coupling thermomicroscopy with
Story source/Credit: Linkam Scientific DSC adds the possibility to measure energy changes
Instruments Limited during the reaction simultaneously, on the same
sample.
Researchers at the University of The research at TMRU used a Linkam heat flux
Huddersfield have combined differential DSC plate incorporated into a hot stage, combined
scanning calorimetry (DSC) with with a T96 temperature controller to study phase
thermomicroscopy to reveal detailed transitions in rubidium nitrate and polyethylene
energy changes in specific materials. oxidation over a -150 to 450°C temperature range.
The results demonstrated the benefits of obtaining
In this first ever study that uses DSC- simultaneous optical data – both images and light
thermomicroscopy to harness the benefits of intensity measurements – with DSC, enabling the
analysing rubidium nitrate and polyethylene detection of small changes in enthalpy.iii
oxidation using both methods simultaneously, Duncan Stacey, Sales and Marketing Director,
researchers at the University of Huddersfield’s Linkam Scientific Instruments commented: “We
Thermal Methods Research Unit (TMRU) used the are just at the start of discovering the potential of
Optical DSC450 System from Linkam Scientific DSC combined with thermomicroscopy. Recent
Instruments to obtain detailed information on the developments in high quality digital microscopes
properties of a broad range of materials, including and improved computing power open up new and
industrial polymers and pharmaceuticals. exciting potential for the in-depth study, via this
Polymers play a critical role in saving energy and method, of materials that are used in our everyday
resources in applications such as healthcare, lives. By observing phase changes such as solid solid
pharmaceuticals, and packaging materials transitions, fusion reactions and decomposition, we
production, and current research has a strong focus can discover new ways to improve the performance
on their potential to support renewable energy and energy profile of materials in application.”
technologies.i As the pharmaceutical industry Dr. Gareth Parkes, Reader in Forensic and
comes under increased pressure to bring new drugs Analytical Chemistry at TMRU added:
to market quickly and cost-effectively, managing a “Understanding the way materials behave under
successful launch programme is growing in different conditions and at carefully controlled
difficultyii – and the industry must continue to find temperatures helps optimise their use in different
new ways to optimise the drug discovery and applications. Simultaneous thermal analysis sheds
development process. new light on the complex thermal processes of
certain materials, because the optical image helps
interpret often complex DSC profiles through the
ability to obtain optical and enthalpic information
on a single sample.iv
“The Linkam DSC450’s precise temperature
control, especially at low temperatures, has proven
an excellent tool in our research. We are now
moving forward to investigate whether the DSC450
can support the study of a material’s thermal
conductivity by optical means, which opens up
exciting new research potential.”

Microbioz India, September 2022 | 46

Product Showcase CloudLIMS Announces
Completion of SOC 2 Type
References II Audit
i Ganachari S.V. (2019) Polymers for Energy
Applications. In: Martínez L., Kharissova O., Story source/Credit: CloudLIMS
Kharisov B. (eds) Handbook of Ecomaterials.
Springer, Cham. CloudLIMS, a cloud-hosted SaaS
ii Ford, J., Elsner, N., Fezza, T., Arora, A.: Deloitte Laboratory Information Management
Insights: Key factors to improve drug System (LIMS), passed the SOC 2 Type II
launches, March 2020. compliance audit to demonstrate its ability
iii Ashton, G.P., Charsley, E.L., Harding, L.P. et al. to maintain enterprise-level security
Applications of a simultaneous differential scanning standards.
calorimetry–thermomicroscopy system. J Therm
Anal Calorim 147, 1345–1353 (2022). CloudLIMS, a leading SaaS company
iv Ashton, G.P., Charsley, E.L., Harding, L.P. et al. offering secure, configurable, high-
Applications of a simultaneous differential scanning quality lab informatics solutions, proudly
calorimetry–thermomicroscopy system. J Therm announces that it has completed the Service
Anal Calorim 147, 1345–1353 (2022). Organization Control (SOC 2) Type II audit. An
independent, third-party Certified Public
About the Thermal Methods Research Unit at Accounting (CPA) firm carried out the SOC 2
the University of Huddersfield Type II audit at CloudLIMS. The third-party
The Thermal Methods Research Unit at the within approval stamps our continued commitment to
the School of Applied Sciences at the University of offer a Laboratory Information Management
Huddersfield carries out research and collaborative System (LIMS) with the best information security
projects using thermal analysis, mass spectrometry offered in the industry.
and instrument development. The TMRU studies a Data integrity and security have been foundations
wide range of materials, from polymers to metal at CloudLIMS. The completion of the SOC 2
oxides, across temperature ranges from sub- Type II audit reinforces that CloudLIMS strictly
ambient to above 1000oC. follows the 5 Trust Services Criteria defined by
SOC 2 to ensure security, availability, processing
About Linkam Scientific Instruments integrity, confidentiality, and privacy of
Linkam develops and manufactures a broad range customers’ data at all times. Compliance with
of temperature and environmental control stages SOC 2 Type II requirements demonstrates that
for both OEMs and end users. From high to cryo CloudLIMS’ privacy and security environment
temperatures as well as humidity, electrical meet the required standards for data security and
connections, gas purging, vacuum and pressure, for integrity.
enhanced sample analysis. Linkam stages are used
with light microscopes and a wide range of analytical
techniques including Raman, FTIR, WAX/SAX
and many more to visualise and characterise
the properties of materials. Linkam stages are found
in thousands of laboratories worldwide with the
most successful microscope heating stage, the
THMS600, selling over 6,000 units alone. Linkam is
the market leader in temperature-controlled
microscopy.

Microbioz India, September 2022 | 47

Product Showcase

The auditor conducted an overall survey of AI-Based Pathology
CloudLIMS’ security measures, including server Diagnosis Tool in
centers, identification and classification of data, Development Detects 7
data encryption-decryption mechanisms, and all Types of Gastric Cancer
assets dealing with any type of confidential or
personal information. Story source/Credit: EVIDENT
In particular, the auditor affirmed that
CloudLIMS has a robust and effective Image data from multiple hospitals
information security program and policies to improves the tool’s versatility and accuracy
protect confidential client data. CloudLIMS’ data
security measures include foolproof identity and Evident, a wholly owned subsidiary of
access controls, review logging, workforce Olympus Corporation, announced the
training, data respectability, incident latest results from its ongoing joint research
management, vendor management, infrastructure program to create an AI-based pathology diagnostic
security, and several other organizational and tool at the 20th annual meeting of the Japanese
physical safety measures. Accomplishing SOC 2 Society of Digital Pathology. The results show the
exhibits CloudLIMS’ obligation to give its clients diagnostic tool in development succeeded in
a secure, dependable, and full-feature LIMS that expanding its AI detection to seven types of gastric
fulfills enterprise-level security requirements. cancer, highlighting its versatility for a range of
"We are incredibly proud of accomplishing the pathology applications.
SOC 2 Type II compliance," said Mr. Arun Apte,
CEO at CloudLIMS. He further added, Meeting the Demand for Diagnostic Tools
"Although the auditing process was stringent and There is an increasing demand for diagnostic tools
time-intensive, it was made conceivable by our that can help reduce the workload of pathologists.
highly-skilled team's effort and dedication by To meet this need, Evident began a collaboration
effectively meeting the various requirements of with the National Hospital Organization Kure
SOC 2 Type II and finishing the auditing cycle Medical Center and Chugoku Cancer Center in 2017
before the estimated time. The compliance to develop an AI-based pathology diagnosis tool.
requires a significant internal resource The first testing phase showed the diagnostic tool
commitment that we are prepared to ensure that could successfully identify adenocarcinoma tissue
our customers are using a LIMS with enterprise- from pathology whole-slide images. As part of
level security standards." the second research phase that began in November
2020, the tool was tested on 2,717 pathology whole-
About CloudLIMS slide images provided by six hospitals³ in Japan to
improve its versatility and accuracy.
CloudLIMS.com offers a zero upfront cost, in the
cloud, SaaS LIMS. CloudLIMS offers strong data Results from the Second Research Phase
security, complimentary technical support, By significantly increasing the amount of image data
product training, instrument integration, through collaboration with the hospitals, the
reporting template, product upgrades, legacy data diagnostic tool improved its AI detection of
migration, and automatic data backups to help adenocarcinoma of tubular and poorly
biobanks, clinical research and diagnostics, differentiated types and expanded its AI detection
COVID-19, and cannabis testing laboratories, to identify other gastric cancers.
manage data, automate workflows, and follow
regulatory compliance such as ISO/IEC
17025:2017, GxP, 21 CFR Part 11, CLIA, ISO
15189:2012, HIPAA, ISO 20387:2018, and
ISBER Best Practices. CloudLIMS.com is an ISO
9001:2015 certified informatics company.

Microbioz India, September 2022 | 48

Product Showcase INTEGRA launches
WELLJET – a
It achieved a false negative rate of 0 to 2.5% in seven revolutionary new and
types of gastric cancer: adenocarcinoma, of tubular, affordable reagent
papillary, mucinous and poorly differentiated types, dispenser
gastrointestinal stromal tumor, MALT lymphoma,
and diffuse large B-cell lymphoma. A common AI Story source/Credit: INTEGRA Biosciences AG
discrimination threshold was set for all hospitals,
demonstrating the improved versatility of the
software.
As the second research phase continues, Evident
aims to further refine the tool to prepare it for
commercial use. The goal of this program is to
deliver an AI pathology diagnosis software that can
assist pathologists by 2023.

About EVIDENT INTEGRA Biosciences has developed the
At Evident, we are guided by the scientific spirit— WELLJET family of dispensers to reduce running
innovation and exploration are at the heart of what costs, increase productivity and provide longer
we do. Committed to making people’s lives walk-away times for bulk microplate filling and
healthier, safer and more fulfilling, we support our reagent dispensing.
customers with solutions that solve their challenges
and advance their work; whether it’s researching Available with or without an automated plate
medical breakthroughs, inspecting infrastructure, or stacker, the WELLJET uses the innovative
exposing hidden toxins in consumer products. EasySnap™ dispensing cassette to provide
Evident Industrial’s solutions range from accurate and precise hands-free filling of
microscopes and videoscopes to nondestructive plates ranging from six to 1536 wells – as well as
testing equipment and X-ray analyzers for deep well plates and tube racks in plate format – for
maintenance, manufacturing and environmental a wide range of applications.
applications. Backed by state-of-the-art The WELLJET's unique, low cost EasySnap
technologies, Evident products are widely used for dispensing cassette (patent pending) is a
quality control, inspection, and measurement. breakthrough for accurate and reliable bulk reagent
Evident Life Science empowers scientists and dispensing. Each cassette features precisely molded
researchers through collaboration and cutting-edge silicone tubing at the interface with the peristaltic
life science solutions. Dedicated to meeting the pump unit, minimizing channel-to-channel
challenges and supporting the evolving needs of its variations and therefore eliminating the need for
customers, Evident Life Science advances a time consuming cassette calibration. In addition, the
comprehensive range of microscopes for pathology, ergonomic and robust design of the cassette ensures
hematology, IVF and other clinical applications as straightforward installation and removal without
well as for research and education. worrying about breaking components or making
mistakes.
About the National Hospital Organization Kure
Medical Center and Chugoku Cancer Center
The Kure Medical Center and Chugoku Cancer
Center is one of the core hospitals in western Japan.
The pathology department performs a large number
of pathological diagnoses on a daily basis, and also
conducts pathological diagnosis of community
medicine in cooperation with Hiroshima University
and the Kure Medical Association Hospital. In
addition, as a tumor pathology laboratory, they are
conducting cutting-edge academic research,
including the field of digital pathology. And as a
member of the National Hospital Organization
Pathology Council, they are also actively conducting
clinical pathology research.

Microbioz India, September 2022 | 49

Product Showcase PhoreMost enters multi-
project drug target
Available in three sterile models – small bore 8 and discovery collaboration
16 channel, and large bore 8 channel – these with Roche
cassettes provide accurate and precise dispensing
over a broad volume range of 0.5 μl to 10 ml. Story source/Credit: PhoreMost Ltd
The WELLJET dispenser and WELLJET dispenser
stacker both feature ultracompact designs to save Dr Neil Torbett, CEO of PhoreMost
valuable bench space or fit inside a laminar flow
cabinet. These dispensers enable a vast number of PhoreMost to deploy its SITESEEKER
applications, from cell-based, kinetic and screening platform to identify novel targets for
assays to ELISAs and genomic or proteomic Roche’s discovery programmes
analyses. Both systems offer quick and efficient set-
up of dispensing protocols via a large, high PhoreMost Ltd., the UK-based
resolution touchscreen and intuitive user interface. biopharmaceutical company dedicated to
The WELLJET dispenser stacker also provides 'Drugging the Undruggable®' disease targets,
hands-free processing of plates, with front-loading has announced it has entered into a multi-project
towers for up to 25 or 50 plates to increase target discovery collaboration with Roche, one of
throughput and extend walk-away times. the world's leading biotechnology companies.
The innovative WELLJET family of dispensers and Under the terms of the agreement, PhoreMost will
EasySnap cassettes will transform the way labs receive an upfront payment and is eligible for
dispense liquids and reagents for daily research preclinical success-based milestones. Further
activities. Visit the INTEGRA Biosciences financial terms are not disclosed.
website to learn more, and to request a demo or PhoreMost will deploy its in-house expertise and
quote. next-generation phenotypic screening platform,
SITESEEKER®, toward disease-relevant pathways
About INTEGRA Biosciences nominated by Roche. Novel targets identified will
INTEGRA Biosciences is a leading provider of be further validated and characterised by Roche’s
high-quality laboratory tools and consumables for R&D organisation, and any SITESEEKER-based
liquid handling and media preparation. The probes would become the starting point for drug
company is committed to creating innovative discovery efforts across a set of disease pathways in
solutions which fulfil the needs of its customers in immunology and haematology.
research, diagnostics and quality control within the
life sciences markets and medical sector. Today,
INTEGRA innovative laboratory products are
widely used all around the world. More than 100
distribution partners form a worldwide sales
network providing responsive and competent
services to customers. These distribution partners
are supported by a highly motivated and
experienced team of specialists at the company
headquarters in Zizers, Switzerland and Hudson,
NH, USA. INTEGRA is an ISO 9001 certified
company.

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