Course Outline

Course Information

• The course begins at the time stated below
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1 | Day 1

18 March 2025

4 November 2025

210 mins | 1:00 PM UK

Introduction

• Introductions and overview of the course and format

Overview of the regulatory requirements for cell bank establishment and testing

• Examine the US FDA and EMA requirements for the cell bank establishment and testing
• Understand the genetic plasticity of the parental cell line
• Cell line establishment
• Examine the specific requirements of the Research Cell Bank (RCB)
• Discuss the various cell bank systems
  • Master Cell Bank (MCB)
  • Working Cell Bank (WCB)
  • End-of-Production Cell Bank (EoPCB)
• End-of-Production Cell Bank (EoPCB) and limit of in vitro cell age (LIVCA)
• Cell bank establishment and testing vs clinical development

Best practices for cell bank system qualification

• Identity testing
• Phenotypic characterization
• Genotypic characterization
• Discuss what safety testing is required
• Discuss strategies to prevent virus contamination
• Alternative methods to virus testing

Case studies 

• Along with the presentation, examples, case studies and a complete literature review will be provided.

Session 2 | Day 2

19 March 2025

5 November 2025

210 mins | 1:00 PM UK

Review best practices for cell freezing and thawing

• Understand the design area for cell banking
• Maintaining homogeneity and distribution
• Review cell freezing techniques
  • Static
  • Dynamic
• Understand the effect of cell phase at freezing
• The critical steps of freezing cells in bags
• A review on Anti-icing agents
• Conditioned media
• The cell thawing procedure
• Options for the seed train: traditional vs continuous

Examine cell banking for cell and gene therapy products (ATMPs)

• Examine the main differences between cell and gene therapy products from biologics
• What regulatory requirements are applicable?

Case studies 

• Along with the presentation, examples, case studies and a complete literature review will be provided.

Examine cell banking for bioassays

• Examine particularities of cell banking for bioassays

Conclusion

• Wrap and summary of the course
• Questions and answer session

Mylène Talabardon – With over 20 years of experience in the pharmaceutical industry, Mylène has 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 the lab scale to manufacturing scale. In 2004, she was appointed head of the cell culture department at Merck Serono and started working in validation according to QbD for biotechnological 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.

Hervé Broly – Starting with an engineering degree in agriculture, followed by a PhD in plant physiology,  Hervé joined the Blood Transfusion Center (Lille, France) in 1982 where he implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, Hervé took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. He took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994.

In 2003, Hervé moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III.

As of November 2006, Hervé has been appointed Vice-President, Head of Biotech Process Sciences at Merck-Serono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.