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

Conference Venue
Pullman Jakarta Central Park
Podomoro City Jl. Let. Jend. S.
Parman Kav. 28 Jakarta
11470, Indonesia

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 Agenda

Monday,
July 1st, 2019

8:30 – 9:00 11:00 – 11:45 14:30 – 15:00

Seminar registration and From process understanding to Halal HAS23000 Certification
morning coffee risk-based filter validation Standard Requirements for
testing Production Facilities
9:00 – 9:15
Tan Ming Wei Dr Ir. Mulyorini R. Hilwan, M.SI
Welcome Speech Sartorius Stedim Biotech Head of auditing division in
Tony BudiantoBee | LPPOM MUI
Adrian Chong
11:45 - 13:00
Sartorius Stedim Biotech
Lunch Break 15:00 – 15:30
9:15 – 10:00 Panel discussion
Validation in Aseptic
Production of Parenteral 13:00 - 13:30
Chair: Tony Budianto Bee | Adrian
products Risk Assessment Single use Chong Panel: All speakers
system
Dra. Rita Endang, Apt, M.Kes
| Director of Production
Lucas Loy,
Supervision of drugs,
Sartorius Stedim Biotech
Narcotics, Psychotropics and
precursor of API (BPOM) 13:30 – 14:15
10:00 – 10:45 Current considerations and
Filter and Single-Use strategies for extractable &
components along the process leachable evaluation
chain from regulatory and Dr Voelkel, Tobias ,
validation point of view Sartorius Stedim Biotech
Dr Voelkel, Tobias , GmbH
Sartorius Stedim Biotech GmbH
14:15 – 14:30
10:45 – 11:00 Coffee Break
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

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
University of Indonesia. She has been joined BPOM
since 2017 as Head of Drug and Food Information Center
and Director of Drug control before she was appointed as
director of Drug, Narcotics, Psychotropics, and precursors
of API production.
Topic:
Validation in Aseptic Production of Parenteral products
Dr Ir. Mulyorini R. Hilwan, M.Si has been active in
auditing halal products since 1996 with the Halal Auditor
team of LPPOM MUI.
Before joining MUI, Mulyorini is a Researchers at the
center of Biotechnology and Life Sciences in IPB
University.
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

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

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