PDA Sponsored Webinar: Post-Approval Change Management for Virus Retentive Filters 2026

A Sponsored Webinar brought to you by Asahi Kasei

During the lifecycle of a biological product a change of the established virus retentive filter may be required due to e.g., supply issues by the manufacturer of a filter currently implemented in the manufacturing process or an improved filter is provided by filter manufacturers. This post-approval change has to meet regulatory guidance, e.g., ICH guidelines, for licensed products. The critical parameters volumetric throughput of product intermediate and, when performed, buffer flush, pressure, pressure/flow interruption, and flow decay have to be validated for the new filter demonstrating the same or improved virus clearance capacity. Furthermore, the quality and safety of the drug product has to be unmodified and comparable drug substance properties regarding, besides virus removal capacity, e.g., impurities and protein aggregates, and potential activation of certain proteins, have to be demonstrated. Therefore, the drug substance properties of the current process have to be compared with the changed process using, beyond QA release assays, tests applied for the drug substance during the development of the virus filtration step. When a risk assessment regarding the potential impact of the change in virus retentive filters results in no negative effects on product quality and safety according to regulatory guidelines, the potential change has to be reported to the relevant regulatory authority in line with existing regional regulations and guidance.