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. , 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.

, 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.