Cell Bank Establishment & Testing_(KL-15)

Online MasterClass 18-19 October, 2023
Cell Bank Establishment

& Testing MasterClass
- EU edition
Mylene Talabardon
HOW YOU WILL BENEFIT:

KEY TAKEAWAYS:
• Take a closer •lookUnderstand

on the newthe
Biological entities
regulatory and Biosimilars
requirements
• Experience the related to cell bank

development of establishment and from
biotherapeutics testingDiscovery to
• Understand how to prevent risk of viral
Market approval contamination when manipulating mammalian cells
• • Strains
Understand the How toand
avoid
Cellquality and reproducibility issues
line development
when establishing the master cell banks and
• Have a chance multiple
to meetworking
the Requirements
cell banks and technical approach for
Phase I, Phase• II, Phase

Understand alternative
III clinical trials analytical methods for
safety testing of cell banks
• Learn about the Control strategy life cycle
• Understand the ICH guidelines and Regulatory pathways for New
Biological entities and Biosimilars in EU and USA
www.glceurope.com
Cell Bank Establishment 18-19 October, 2023
& Testing MasterClass Online MasterClass
- EU edition
INTRODUCTION
The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH
Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant
proteins and gene therapy products. The MCB is one element of the cell bank system which
comprises also the Working Cell Banks (WCB) and the End-of-Production Cell Bank (EoPCB).
The qualification of the cell bank system, which comprises identity testing, phenotypic &
genotypic characterization, and safety testing, is a principal component that ensures process
performance and reproducibility, the quality of the end product and is one element of preventive
measures to prevent potential safety issues for the patients.
The Master Class will also address potential issues encountered when establishing cell banks
and will discuss operational aspects for ensuring good quality cell banks.
WHO SHOULD ATTEND?
• Process development scientists and managers

• CMC development program managers
• Manufacturing managers and operators
• Quality Assurance representatives
• Regulatory Affairs representatives
www.glceurope.com booking@glceurope.com +36 11 848 05 96

848 0515
- EU edition
Meet the Trainer:

Myléne Talabardon
With over 20 years of experience in the pharmaceutical industry, Mylène has a strong experience in process
development, technology transfer and process validation. She obtained her PhD in biotechnology from The
Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology
(EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from
lab scale to manufacturing scale. In 2004, she has been appointed head of cell culture department at Merck
Serono and started working in validation according to QbD for biotech products. After 2 years as CMC lead for a
biosimilar product, she was nominated Process Validation Expert, and in this position, she developed the Global
Process Validation strategy for the company according to European and FDA regulations for pharmaceuticals,
and supported CMC teams in developing Process Validation plans for new biologics as well as for legacy products.

848 0515
- EU edition
We reserve the right to make slight adjustment in the training program
DAY1 DAY2
08:55 Connecting to the Online MasterClass 08:55 Connecting to the Online MasterClass
09:00 Introduction 09:00 Cell freezing and thawing

• Cell banking area design
09:15 Regulatory considerations on cell • Homogeneity and
distribution
bank establishment and testing • Cell freezing (static /
dynamic)
• Parental cell line
• Effect of cell phase at
• Cell line establishment /
freezing
Research Cell Bank • Freezing in bags
• Cell bank system – • Anti-icing agents
MCB/WCB/EoPCB • Conditioned media
• End-of-Production Cell Bank • Cell thawing
(EoPCB) and limit of in vitro • Seed train (traditional /
cell age (LIVCA) continuous)
• Cell bank establishment &
testing vs clinical development
10:30 Break
10:30 Break
11:00 Particularities for gene
therapy products and cell
11:00 Cell Bank System Qualification therapy products
• Identity testing • Gene therapy products
• Phenotypic characterization • Cell therapy products
• Genotypic characterization
• Safety testing
• Prevention of virus
Bibliography and
contamination regulatory guidelines
• Alternative methods to
virus testing 12:15 Questions & answers
12:30 END
End of day 1 12:30 Feedback/Evaluation session
12:40 END
End of day 2
All dates and times are expressed in UTC/GMT+2

on the Agenda (CET Time Zone).

848 0515
- EU edition
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848 0515
Registration Form
Cell Bank Establishment & Testing EU MasterClass
18-19 October, 2023, Online MasterClass
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KL-15 MASTERCLASS FEE

Attendance Fee - 1998 € / 1 or 2 delegates* Solution Provider Fee - 1998 € / delegate
*This offer is NOT valid for industry consultants, service or solution providers
*The offer is valid for limited number of seats only
38 EUR administration charge will be applied
Participation fee includes: Full access to the live virtual training | Course material | Digital certificate
Get the recording of the event for an additional 499 €

Please note that the pricing of the recording is subject to change, in case it is requested after the event
Your GLC Contact Person: krisan@glceurope.com

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Online MasterClass 18-19 October, 2023