Building A Control Strategy for Cell Therapies That Remains Robust from Phase 1 Through BLA to Minimize Costly Delays

• 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

Speakers:

Jiangli Yan

Senior Director, Analytical Science & Technology,=

Vertex Pharmaceuticals