Testing for the presence of replication competent adenovirus (RCA) is a key component to ensure patient safety and a requirement for all biologicals manufactured using adenoviral vectors. For many adenoviral-based products, the RCA assay is a rate-limiting assay for lot release.
Join this webinar to learn about a rapid RCA detection assay currently in development, which combines a 7-day culture assay with a highly sensitive molecular endpoint specific for RCA. The method can detect the presence of as little as 1 RCA in adenoviral vector material at an approximate concentration of 5x107 - 2x108 vector particles (VP)/mL, making it a suitable method to meet regulatory requirements while accelerating your lot release timelines.
In this webinar, you will learn about:
- Regulatory framework for adenoviral vector products
- Considerations for lot release testing of adenoviral-based therapies
- Advantages of a rapid method for RCA testing on production lot material
Speakers
Alberto Santana, MBA
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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.
Axel Fun, Ph.D.
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Axel Fun, Ph.D.
Axel Fun is the principal scientist for virology in development services, responsible for developing new assays for the virology portfolio and providing scientific and regulatory advice regarding virus safety testing. Axel has extensive experience in virus research and biosafety testing and has been in his current role for almost 5 years.
Axel holds an M.S. in Infection & Immunity and a Ph.D. in virology from the University of Utrecht in the Netherlands. Prior to his current role, Axel worked for 5 years as an academic researcher at the University of Cambridge, United Kingdom.
Pharma and biopharma manufacturing
- Gene therapy manufacturing
Duration:45min
Language:English
Session 1:presented April 28, 2022
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