As AAV programs progress into larger clinical studies and commercial manufacturing, decisions made early in development can have far-reaching consequences for product safety, process robustness, and regulatory readiness.
In this webinar, we explore emerging scientific and regulatory perspectives on AAV quality. We review the significance of the FDA Advanced Manufacturing Technology (AMT) designation, the growing focus on impurity control, and how the manufacturing approach can help support future regulatory acceptance. Attendees will learn why reducing impurity burden is not solely a downstream challenge and how cell-line engineering, process development, and manufacturing strategy can work together to strengthen product safety from the start.
Join us to discover how integrated approaches to impurity control can help reduce downstream complexity, improve manufacturing robustness, and create a stronger foundation for clinical advancement and future commercialization. The discussion will provide practical insights for process development, CMC, clinical development, analytical, quality, and MSAT teams working to move AAV therapies forward with greater confidence.
In this webinar you will:
- Navigate emerging regulatory and quality expectations for AAV manufacturing.
- Identify the impurity species that matter most, including encapsidated host-cell DNA, plasmid-derived DNA, and partial genomes, and their potential impact on product safety.
- Evaluate how cell-line engineering and process design can reduce impurities at the source, helping strengthen quality before downstream purification.
- Apply integrated manufacturing strategies that can improve product safety, manufacturing robustness, and regulatory readiness.
Who should attend: Gene Therapy/Viral Vector:
- Process development scientists
- Clinical development professionals
- CMC and technical development leaders
- Analytical development, quality, and MSAT professionals