Detection and Clearance of Viruses in the Biopharmaceutical Industry

摘要

Viral contamination is a common threat to all animal- and human-derived biopharmaceuticals. This type of contamination can affect any part of a bioproduction process, so biomanufacturers need to perform viral testing studies and incorporate viral clearance methods into their processes.Viral contaminants can come from cell lines (e.g., endogenous retroviruses) or from adventitious (e.g., mycoplasma) introduction during drug manufacturing. Virus testing of master cell banks (MCBs), working cell banks (WCBs), end-of-production cell banks, and bulk unprocessed harvest material is called for in guidance documents including Q5A from the International Council on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) (l). Regulators also recommendthat manufacturers source raw materials appropriately and use effective methods for demonstrating viral clearance — and to use a risk-based approach when doing so.