Filtration Methods To Overcome New Challenges In Viral Safety

By Lawrence Okorafor, Scientist II, Morven McAlister, Senior Director, and Nigel Jackson, Principal Engineer, R&D

Virus filtration is crucial for ensuring viral safety in biotherapeutic manufacturing. Leveraging new industry insights, several contemporary challenges have been successfully addressed, including the effect of low pressure on virus breakthrough, upstream virus filtration for advanced medicinal therapeutic products (ATMPs), validation issues from adsorptive prefilters, and the extended processing times and lower pressures of continuous virus filtration. This study offers valuable insights to guide informed decisions in virus filtration, aligning with both the PDA TR-41 (2022) (Parenteral Drug Association Technical Report - 41) and the ICH-Q5A (International Council for Harmonization) updated guidelines.