Abstract
For drug products manufactured in mammalian cells, safety assurance
practices are needed during production to assure that the final
medicinal product is safe from the potential risk of viral
contamination. Virus filters provide viral retention for a range of
viruses through robust, size-based retention mechanism. Therefore, a
viral filtration step is commonly utilized in a well-designed
recombinant therapeutic protein purification process and is a key
component in an overall strategy to minimize the risks of adventitious
and endogenous viral particles during the manufacturing of biotechnology
products. This review summarizes the history of viral filtration,
currently available viral filters and prefilters, and viral filtration
integrity test methods and study models. There is also discussion of
current understanding and gaps with an eye toward future trends and
emerging filtration technologies.
KEYWORDS: Virus Retentive Filters; Downstream Bioprocessing; Viral
Clearance Validation; Continuous Manufacturing; Mechanisms of Removal;
Monoclonal Antibodies; Recombinant Therapeutic Proteins; Virus Diameter;
Parvovirus; Sieving; Barrier Filtration of Media; Membranes; Hollow
Fibers.