Applications of Next Generation Sequencing for Viral Safety in Light of ICH Q5A R2

ICH Q5A (R2) on “viral safety evaluation of biotechnology products derived from cell lines of human or animal origin” has been signed-off in November 2023 and moved to the implementation stage.  The revised guidance covers additional products such as viral vectors and advanced processes, i.e., continuous manufacturing.  The concept of using “prior knowledge” in viral clearance studies and the option to replace animal testing with “next generation sequencing (NGS)” are introduced.  While manufacturers of products, e.g., vaccines, for which animal tests are required for release of each production batch, made significant strides in establishing NGS capabilities, manufactures of protein therapeutics such as monoclonal antibodies are rather at the beginning of this journey and may rely on third parties for NGS testing of cell banks.  Considering ICH Q5A (R2), an updated viral safety strategy for CHO processes will be discussed.

Presented by Jurgen Mullberg Associate Director at Bristol Myers Squibb

Jürgen received a Ph.D. in Biology from RWTH Aachen in Germany. He studied molecular mechanisms of inflammation and immune modulation in both, academia and biotech. His previous work in Biopharmaceutical firms (Dyax & Novartis) focused on the expression of therapeutic proteins and vaccines in mammalian cell culture. Currently, Jürgen serves as network viral safety SME at Bristol Myers Squibb and provides guidance on adventitious agent control and safety of manufacturing processes and cell substrates.

Colette Côté, Ph.D. Chief Scientific and Portfolio Officer & General Manager at PathoQuest Inc.

Dr. Côté has nearly 20 years of experience in industry with a focus on applying & expanding the use of NGS in the biosafety testing field. She recently was Head of NGS R&D Testing Services at MilliporeSigma, a well-known stakeholder of the biosafety testing and viral vector manufacturing industry. She started her career as a Senior Scientist at Intronn Inc, and then moved to Innovative Biosensors Inc where she developed and engineered biosensors for rapid biodefense and clinical pathogen detection. Colette received her Ph.D. in Molecular Biology, Cell Biology, and Biochemistry from the Brown University and completed her postdoctoral fellowship in the Genetics and Biochemistry Branch at the NIH. She contributed to various papers, publications, and patents throughout her career.

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