by Denis Kole, Principal Scientist, Scientific and Laboratory Services, Pall Biotech
Virus safety is a key element in biopharmaceutical manufacturing. Inherently, animal cell culture involves risks related to virus safety. Chinese Hamster Ovary (CHO) cell lines are the most common production platform for expressing glycosylated proteins and monoclonal antibodies. Being from rodent origin, CHO cell lines may contain endogenous retroviruses or retrovirus-like particles. Additional virus safety risks come from the possibility of the cell culture being contaminated by adventitious viruses. As a consequence, the regulatory expectation for manufacturing platforms is to demonstrate the ability to remove or inactivate a wide range of viruses to minimize the impact of viruses on patient safety.
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