Industry Insight: Applying QbD Principles For AAV Sterilization Filter Selection In Drug Substance Clarification And Final Drug Product Processing

In the development of gene therapies, the adeno-associated viral vectors (AAVs) have garnered significant interest for numerous applications because of their broad host infectivity range and acceptable safety profiles. Successful clinical translation and market approval of AAV-based therapeutics hinges on developing robust AAV manufacturing processes that can produce products with the desired characteristics critical to product quality and patient safety.

Defining the appropriate Chemistry Manufacturing and Controls (CMC) strategies for AAV-based gene therapies is one of the biggest obstacles facing developers and presents a significant risk to the success of new Investigational New Drug (IND) applications for potential candidates. To avoid setbacks, regulatory bodies like the FDA have been advocating the Quality by Design (QbD) approach to fulfill regulatory expectations for CMC information.

Explore expert guidance and recommendations based on QbD principles for the successful implementation of sterilizing grade filters in AAV manufacturing processes. Sterilizing grade filtration plays an important role in AAV manufacturing, both for drug substance (DS) and final drug product (DP) to ensure patient safety.