Building a Control Strategy for Complex Analytical Methods to Ensure Commercial Testing Stability for Cell Therapies

• 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