How To Plan For Trouble-Free Filter Validation

For any drug product application where the final sterilizing-grade filter is used to claim a sterile filtrate (i.e., for drug products that cannot be terminally sterilized), there is a regulatory expectation that process-specific filter validation studies are performed before an application is submitted for marketing authorization to commercially produce the product (New Drug Application (NDA) in the US or Marketing Authorization Application (MAA) in the EU and other countries). This could also be required when an end user changes their manufacturing conditions relating to final sterile filtration.

Since filter validation became a regulatory expectation, the range of drug products has only increased, from small molecules to monoclonal antibodies to most recently, advanced therapy medicinal products (ATMPs). Each drug product type has unique considerations for final sterile filtration, and end users must be prepared to justify the final filter validation design space.

In this webinar, we review best practices to ensure that process-specific filter studies are performed as expected and that the data generated supports the end user’s intended final sterilizing-grade design space. Watch to learn when filter validation should be performed, what is required from an end user and laboratory testing perspective, and how to achieve first-time success for different types of drug products.