Virus filtration is a critical unit operation in the manufacture of biotherapeutic products. Rigorous and careful validation of this process-dependent step is necessary to demonstrate that the selected virus filter meets regulatory requirements. Thoughtful design and implementation of spiking studies are imperative to successful validation, and these studies may include consideration of various robustness and process parameters. Overall, the study design should be conducted as a representative scaled-down model of the eventual manufacturing process, and as such, the virus filters should be scalable without introducing variables related to scale of process and should show consistent virus removal and filtration performance without lot-to-lot variation. Further, the study and assay methods should be validated and comply with industry standards.

In this webinar, we identify the critical parameters to consider in study design and offer a commonsense approach to validating virus filtration unit operations. We also introduce the addition of non-GLP viral clearance study support as a planning tool for Planova™ filter customers.

Watch the recorded webinar from Asahi Kasei Bioprocess to learn more about:

•     Best practices in viral clearance studies with case study examples
•     Planova™ virus removal filter scalability from validation (virus spike) to manufacturing
•     Non-GLP viral clearance study support for Planova filter customers