Watch On Demand:

Virus safety testing is an important part of the strategy to assure the safety of biological drugs. Well-established test methods and test regimes are laid down for this purpose in pharmacopoeias and guidelines and have been used successfully over decades now.

The manufacturing processes of innovative cell and gene therapy products have no or only limited viral clearance capacities. Therefore, virus safety testing is key for the used starting materials and raw materials to prevent that viral contaminants are introduced into the manufacturing process. In addition to or as an alternative to traditional viral detection methods, next-generation sequencing (NGS) can be utilized for the detection of viral contaminants. Furthermore, probably present replication competent viral vectors in gene therapy products and genetically modified cell therapy products pose a potential risk for patients and must be considered in the virus safety test program.

This webinar highlights the core principles and key considerations of viral safety testing tailored to the unique characteristics and risks of cell and gene therapy products.

You will learn

• Viral contamination risk mitigation strategy for biologics
• Viral contamination risk mitigation strategy for CGT
• Traditional adventitious virus detection methods & limitations
• Virus detection by NGS
• Adventitious agent test strategy for HEK293 cells
• Replication competent viral vectors

Speakers

Dr. Kerstin Brack,
Scientific Director, Global Biosafety,
Charles River Laboratories Germany GmbH

Dr Kerstin Brack has been a Scientific Director at Charles River since 2018 and a subject matter expert for biosafety testing of biologicals. She holds a Diploma in Biology from the University of Bremen (Germany) where she subsequently also earned her PhD in Virology. In 2001 Kerstin joined NewLab BioQuality AG (now Charles River Laboratories Germany GmbH) as a Study Director for virus and prion validation studies. She was also responsible to establish analytical test methods for biosafety testing of biologicals as well as cell-based potency assays. Between 2004 and 2018. Kerstin managed the departments for biosafety and bioassay services at Charles River Laboratories Germany.