Virus Clearance

Virus contamination poses a threat to the safety of biopharmaceuticals derived from recombinant or human plasma sources. Manufacturing processes must provide clearance of endogenous and adventitious viruses for product safety. The entire manufacturing process is qualified to achieve a cumulative virus reduction factor, which significantly contributes to the documentation of virus safety. In many of these manufacturing processes, a virus-retentive filter provides a robust virus clearance step. Millipore's family of Viresolve filters retains viruses to ensure maximum product recovery.