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International activities for standardization of a comprehensive virus detection testing

Many of “biologics” such as antibody drugs, vaccines, and gene/cell therapy products are made with/out of human or animal-derived cells. In addition, in the production process of these biologics, various kinds of human/animal-derived ancillary materials are often used in their production. Appropriate quality assessment should be required for these cell substrates and ancillary materials. Especially, virus safety should be ensured based on scientific evidence. It is important not only to take measures to prevent contamination of infectious viral particles but also to evaluate the safety/activity of endogenous viruses in cell-substrates. In recent years, with the emergence of novel types of therapeutics or innovative manufacturing technologies, the use of new kinds of cell substrates or ancillary materials has been increased. Nevertheless, they have not been well evaluated for virus safety. Therefore, an international collaborative platform has been provided to discuss the usefulness of new methods enabling us to detect even novel or unexpected viruses. In this session, we are going to cover various topics on virus safety for biologics: genome science of cell-substrates, regulatory trends, etc., and also would like to discuss a new trend of virus safety testing.

New trends in ensuring virus safety in biologics

The 141st Annual Meeting of the Pharmaceutical Society of Japan (Hiroshima)

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[S19-4]International activities for standardization of a comprehensive virus detection testing

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