Virus Retentive Filters

Abstract Ensuring the absence of detectable viruses in biopharmaceutical products is imperative from both a regulatory and patient safety standpoint. Biopharmaceutical viral safety is the result of multiple orthogonal barriers operating in concert; incorporation of virus clearance methods is an important strategy to achieving product safety. Filtration through virus retentive filters is currently a key unit operation during the production of biopharmaceuticals and plasma‐derived products. Careful process design and appropriate validation are critical for the successful implementation and performance of virus retentive filters. Here we elaborate on both process design and validation information, describe virus filters currently on the market, and discuss the historical experience with virus retentive filters as reported in the scientific literature. Detailed information for filter users can be found in a comprehensive technical report (TR 41) promulgated by the Parenteral Drug Association (PDA) (1).