In-House Training
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. It will address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks. 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 the cell banking for biopharmaceuticals, as well as particularities for cell & gene therapies and bioassays. Along the presentation, examples, case studies and a complete literature review will be provided.
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.
This course is aimed at professionals involved in cell banking for biologics, cell & gene therapies and bioassays.
Process development scientists and professionals
Upstream process scientists and professionals
CMC development program managers
CMC project managers
Quality Assurance professionals
Regulatory Affairs professionals
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 for commercial production vs clinical production
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 cell based methods and in vivo methods for virus testing
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 with cell and gene therapy products from biologics
• What regulatory requirements and testing are applicable?
Examine cell banking for bioassays
• Examine particularities of cell banking for bioassays
Conclusion
• Wrap and summary of the course
• Questions and answers session
Please contact us at mylene.talabardon@biotechnologyconsultant.com