Virus Filtration

Abstract

Biopharmaceutical products account for a large proportion of the recently developed medicinal drugs. Owing to their production in biological systems utilizing purified protein products from human blood plasma or recombinant production in cultured cells, biopharmaceuticals are at risk of virus contamination and, therefore, targeted virus removal steps are required in manufacturing processes for these products. Among several established methods for removing viruses, virus filtration has been widely adopted as the most reliable and robust method with effective clearance of a wide range of viruses. Here, we trace the history of the development of virus filters, describe the mechanism of virus removal, and explain the technical features of virus filters. Additionally, basic principles for using virus filters, including necessary user integrity tests and process validation are provided along with specific examples of current applications and new trends in their implementation.