Virus filter validation
What virus spike should you use?
Regulators demand multiple, orthogonal technologies that together achieve high log reduction of viruses. With low pH viral inactivation and chromatography, filtration adds a simple and robust clearance step based on virus size that assures viral safety by removing all viruses including 20 nm parvoviruses.
Viral safety in plasma products and complex biotech processes provides a different filtration challenge to that from highly purified mAb processes. Virus filters (Pall™ Life Sciences products) specifically optimized to meet this challenge, and/or the addition of prefiltration, are essential for economy and robust performance.
Processes that are critical to the product safety profile, including virus filtration, demand close control to assure they perform as expected, every time. Fully automated systems reduce the risk of operator error, simplify processing, and increase batch compliance.