Fireside Chat: From Clinical Supply to Commercial Launch: Ensuring PPQ Readiness & BLA Success in Viral Vector Manufacturing

• Outlining what regulators expect from PPQ runs in viral vector manufacturing: consistency, reproducibility, and demonstration of process control across multiple consecutive batches
• Sharing strategies for scaling processes developed at early-stage to commercialready platforms without compromising quality or timelines

Speakers:

Amol Thote

Sr. Director

Gilead Sciences

Michael White

CSO and Co-Founder

Independent Expert