Characterization of cell substrates, virus seed stocks and virus harvests, used in human vaccine production, for identity and purity is required by regulators worldwide. Presentation will give an overview of the regulatory requirements given in the latest guidance documents from the US FDA, WHO, European Pharmacopoeia and ICH. Differences between these documents will be highlighted. New technologies for determining the identity of cell substrates and virus seed stocks and detecting adventitious agent contamination will be described.
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