Regardless of the biotech product, careful characterization of the cell banks used in its production is the first step in mitigating the risk of a contamination event. In fact, cell line characterization is an important component of the overall viral safety strategy for the product. In this webinar, we describe the testing necessary to ensure cell banks are free from infectious and other adverse agents and that they meet current regulatory expectations. Different levels of testing are performed for master, working, and end-of-production cell banks, and we will also discuss those differences.
In this webinar, you will learn:
- The types of tests that are needed to fully characterize your cell banks
- The best tests to use for your particular cell line
- Reasons why a viral contaminant may be missed
Speakers
Kathryn Martin Remington, Ph.D.
Merck
Technical Consultant
Kathryn Martin Remington, Ph.D. is a member of the field technology management group and provides U.S. clients with technical and regulatory support. Kathy joined the organization in 2010 from Catalent Pharma Solutions where she established a viral clearance program. She was also the section head of the viral validation group for Bayer Healthcare. During her nearly 20 years in viral clearance, she has authored a number of publications on the viral safety of biopharmaceuticals. Kathy earned her M.S. and Ph.D. degrees in microbiology from the University of Montana.
Alberto Santana, MBA
Merck
Product Manager, Biologics Biosafety Testing
Alberto Santana is the biologics biosafety services product manager, responsible for the development of new services and portfolio development. Alberto has experience across the biopharma and pharma industries, including product management with Roche and Janssen.
Alberto holds an MBA and an M.S. in Pharmaceutical Management from the IE Business School in Madrid, Spain, and an economics degree from Universidad Católica Andrés Bello, Caracas, Venezuela.
Pharma and biopharma manufacturing
- Cell Line Development
Duration:45m
Language:English
Session 1:presented January 21, 2021
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