Jiangli Yan
Senior Director, Analytical Science & Technology,= Vertex Pharmaceuticals
Seminars
Wednesday 2nd December 2026
Building A Control Strategy for Cell Therapies That Remains Robust from Phase 1 Through BLA to Minimize Costly Delays
11:30 am
- Evaluating when early characterization assays should be retained, removed or moved into release testing
- Refining specifications and acceptance criteria as development progresses across phases
- Aligning analytical decisions with evolving CMC and regulatory strategy on the path to BLA
