Philip Wills
Chief Commercial Officer, Cell and Gene Therapy Catalent
Seminars
Thursday 26th February 2026
De‑Risking Clinical & Late‑Stage AAV with Robust Analytics
10:00 am
- Considerations for phase-appropriate AAV characterization and release activities from pre-clinical to late-phase products.
- Discussion on how to leverage platform analytics, client-specific methods and transfers, formulation verifications, tox material testing, and stability for early-stage and continued development activities, timing of method validation, IPC verifications, and data trending for late-stage.
- Potential challenges in validation of late-stage analytics for PPQ and commercial testing and paths for maturation of platform and product-specific analytics.
