Scaling What’s Never Been Scaled: Lessons Learned From Building Late- Stage Manufacturing Readiness for Global PCV Trials
Time: 9:00 am
day: Pre-Conference Manufacturing Focus Day
Details:
• How to design a scalable, modular manufacturing model to enable Phase II/III execution without overcommitting pre-commercial – including lessons from scaledown modeling to simulate future bottlenecks
• Strategic considerations in platform selection and core workflow standardization to support repeatability, reduce cost, and accelerate late-stage development
• Lessons from early investments in future-proofing critical processes – minimizing tech transfer complexity and enabling global trial expansion and real-world access
