Streamline the Critical Path for Gene Therapy: Key Considerations for the AAV Analytical Lifecycle
Abstract: AAV vectors offer clear benefits for gene therapy, and continued advances in technology have increased target specificity, improved potency, and intensified production efficiency. Even with significant attention early in development, analytical activities for gene therapy often land on the critical path. This webinar provides considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products. Early-stage analytical topics will address how to leverage platform analytics, client-specific methods and transfers, formulation verifications, tox material testing, and stability. Late-stage focus will review continued development activities, timing of method validation, IPC verifications, and data trending. We will discuss potential challenges in validation of late-stage analytics for PPQ and late-phase testing and paths for maturation of platform and product-specific analytics.