Event-Booklet_Sartorius-Seminar-Indonesia_v1-2019_A4

CONFIDENCE in Bioprocessing – Risk Based
Approach towards E&L & Aseptic processing

July 1st, 2019 | Jakarta, Indonesia

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Welcome

In the rapid and dynamic development of the biopharmaceutical
market today, more biopharmaceutical companies are seeking
optimization and improvement in their production process. These
optimization and improvements often surround the introduction of
single use technology into manufacturing processes, for a safer and
more efficient production process.

This process of introducing single use technology, has raised
questions regarding filtration optimization, cost reduction,
improvements of recovery rate, seamless and fully closed single use
process bridging the thawing of bulk drug substance to final filling
and an effective risk assessment to consider all the various risks in
the process are always revolving within the industry.

With these questions, Sartorius invited well-known technical
experts from the industry to share critical information and keys to
help in resolving these concerns.
We look forward to welcoming you to our seminar in Indonesia!

Tony Budianto Bee Adrian Chong
Head of General Sales, SEA Manager of Application
Specialist

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Menara Peninsula Hotel
Jl. Let. Jend. S. Parman 78,
Jakarta 11410, Indonesia.

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Agenda

Monday,
July 1st, 2019

8:30 – 9:00 11:00 – 11:45 14:30 – 15:00
From process understanding to Halal HAS23000 Certification
Seminar registration and risk-based filter validation Standard Requirements for
morning coffee testing Production Facilities
Tan Ming Wei Dr Ir. Mulyorini R. Hilwan, M.SI
9:00 – 9:15 Sartorius Stedim Biotech Head of auditing division in
Welcome Speech LPPOM MUI
11:45 - 13:00
Tony BudiantoBee | Lunch Break 15:00 – 15:30
Adrian Chong Panel discussion
Sartorius Stedim Biotech 13:00 - 13:30
Risk Assessment Single use Chair: Tony Budianto Bee | Adrian
9:15 – 10:00 system Chong Panel: All speakers
Validation in Aseptic
Production of Parenteral Lucas Loy,
products Sartorius Stedim Biotech

Dra. Rita Endang, Apt, M.Kes 13:30 – 14:15
| Director of Production Current considerations and
Supervision of drugs, strategies for extractable &
Narcotics, Psychotropics and leachable evaluation
precursor of API (BPOM) Dr Voelkel, Tobias ,
Sartorius Stedim Biotech
10:00 – 10:45 GmbH
Filter and Single-Use
components along the process 14:15 – 14:30
chain from regulatory and Coffee Break
validation point of view

Dr Voelkel, Tobias ,
Sartorius Stedim Biotech GmbH

10:45 – 11:00
Coffee Break

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Speaker Line-Up

Voelkel, Tobias

Voelkel, Tobias holds a Master’s degree in biochemistry from the
University Witten/Herdecke (Germany) and worked for Miltenyi
Biotech as well as German and US Research Laboratories in
various R&D positions focusing on cell therapies and protein
biochemistry.

He joined Sartorius Stedim Biotech as Project Manager for
CONFIDENCE® Validation Services in 2015. With focus to the
Asia|Pacific region Tobias consults (bio)pharmaceutical customers
in the field of filter and single-use systems validation.

Based on regulatory requirements and risk assessment principles
he manages validation studies regarding sterility, physico-
chemical studies and extractables | leachables.

Topic:
Filter and Single-Use components along the process chain from
regulatory and validation point of view

Event-Booklet_Sartorius-Seminar-Singapore-2018_A4-e.indd 4 Tan Ming Wei

Tan Ming Wei is responsible for the filtration topics within SEA,
providing filter related training & technical support, identifying
opportunities for filtration optimization and streamlining of
processes.

He is also developed as a validation champion to support his
customer on regulatory compliance topics. He started off his
career at Baxter Bioscience as a Biotechnologist in Upstream Cell
Culture | Media Prep | Innoculation.

Over the years, Ming Wei progresses to a Process Engineer,
involved largely in tech transfer and critical investigation relating
to product quality and product yield.

Topic:
From process understanding to risk-based filter validation testing

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Dra Rita Endang, Apt, M.Kes Dr Ir. Mulyorini R. Hilwan, M.Si

Dra Rita Endang, Apt, M.Kes has graduated from Dr Ir. Mulyorini R. Hilwan, M.Si has been active in
University of Indonesia. She has been joined BPOM auditing halal products since 1996 with the Halal Auditor
since 2017 as Head of Drug and Food Information Center team of LPPOM MUI.
and Director of Drug control before she was appointed as
director of Drug, Narcotics, Psychotropics, and precursors Before joining MUI, Mulyorini is a Researchers at the
of API production. center of Biotechnology and Life Sciences in IPB
University.
Topic:
Validation in Aseptic Production of Parenteral products Now, as the Head of auditing division, she responsible to
guarantee Halal certified products based on the
HAS23000 Halal Certification Requirements .

Topic:
Halal HAS23000 Certification Standard Requirements
for Production Facilities

Lucas Loy 05.11.18 15:14
Lucas Loy graduated from Nanyang Technological University,
Singapore, with a Bachelor Degree in Biological Sciences.
Prior to joining Sartorius, he worked in Amgen and took part
in the tech transfers of 2 molecules from Amgen US to
Singapore and was the Process Lead for Bulk Drug Filling and
Harvest process.
In his current position with Sartorius, Lucas aims to help
emerging and existing biopharma companies to integrate
single-use technologies into their processes.

Topic:
Risk Assessment Single use system

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Notes

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Sartorius Stedim Singapore Pte Ltd
10 Science Park Rd, #02-13/14
Singapore Science Park II,
Singapore 117684

Phone +65.6872.3966

www.sartorius-stedim.com 05.11.18 15:14

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