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Virus Retentive Filtration In Biopharmaceutical Manufacturing

Source: Parenteral Drug Association (PDA)
Parenteral Drug Association (PDA)

By Dayue Chen, PhD, Eli Lilly and Company, and Qi Chen, PhD, Genentech

A Review of the Benefits and Challenges of Parvovirus Retentive Filters

Virus removal using retentive filters designed to provide effective and consistent clearance of parvovirus (~20 nm) has now become an established standard in downstream purification processes for biologics produced using mammalian cells (1). Compared to other commonly used virus clearance methods, such as chromatography and low pH inactivation, retentive filtration is superior in its ability to clear almost all potential viral contaminants while also avoiding adverse effects on product quality. While commercially available retentive filters vary in chemical composition and structural configuration, all of these filters primarily clear viruses through the mechanism of size exclusion (1–3).

Parenteral Drug Association (PDA)