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Cell Bank Establishment & Testing for Biologics, Bioassays and Cell & Gene Therapies

12 & 13 November 2024 | Short Online Course

Original price was: £495.00.Current price is: £396.00.

2-day Live Online Training 

Gain the confidence to manage cell banking for biopharmaceuticals and ATMPs

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Course Overview

 

Cell banking establishment and testing are important processes when developing and manufacturing a biopharmaceutical or cell & gene therapy product. Establishing a successful Master Cell Bank (MCB) is critical as they are the primary source of cells from which Working Cell Banks (WCB) are derived. The manufacturing process relies on there being a consistent supply of viable cells so this process must be performed efficiently.

 

This short live online course will provide you with the confidence to manage cell banking for biopharmaceutical and advanced (ATMP) products. You will explore the key regulatory requirements for establishing and testing various cell banks to ensure compliance and quality. Once completed, you will have the skills to qualify a cell bank system, which comprises identity testing, phenotypic & genotypic characterization, and safety testing.

 

The course will examine cell banking for biopharmaceuticals, as well as particularities for cell & gene therapies and bioassays. Along with the presentation, examples, case studies and a complete literature review will be provided.

 

Learn more about how we deliver live online training.

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Enrol before 18 October to save 20% (November Course)

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Key Learning Objectives

 

  • Understand the regulatory requirements related to cell bank establishment and testing
  • Case study examples for biologics, cell & gene therapies and bioassays
  • Master cell banking system qualification
  • Examine specific cell bank systems including MCB, RCB, WCB and EoPCB
  • Learn how to mitigate the risk of viral contamination during the manipulation of mammalian cells
  • Discover strategies to prevent quality and reproducibility issues when creating master cell banks and multiple working cell banks
  • Explore alternative analytical methods for the safety testing of cell banks

What is Included?

 

  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Download the Agenda

 

You can view the agenda below or if you would like to receive a pdf version with all the course information, please complete the form below.

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Course Dates

 

Find out when this course is running so you can plan your training.

12 & 13 November 2024

7-Hour Course Delivered Over 2-Days

Register at the top of the page.

2025 Dates TBC

7-Hour Course Delivered Over 2-Days
Register at the top of the page.

2025 Dates TBC

7-Hour Course Delivered Over 2-Days
Register at the top of the page.

Learn more about the course by toggling through the tabs below (trainer, who should attend?)

 

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

12 November 2024

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

13 November 2024

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.

This course is aimed at professionals involved in cell banking for biologics, cell & gene therapies and bioassays. These include:

  • Process development scientists and professionals
  • Upstream process scientists and professionals
  • CMC development program managers
  • CMC project managers
  • Quality Assurance professionals
  • Regulatory Affairs professionals
Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

 

Complete our contact form by following the link. Get in touch.

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• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training

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Cell Bank Establishment & Testing for Biologics, Bioassays and Cell & Gene Therapies

12 & 13 November 2024 | Short Online Course

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