Bridging the Inflection Point from Early Development to Late-Stage Manufacturing to Support Phase II/III Expansion

• Transitioning from low-volume, flexible production to high-throughput, standardized manufacturing systems
• Scaling batch sizes while maintaining product quality, consistency, and regulatory compliance
• Identifying infrastructure, equipment, and workforce requirements for late-stage trials
• Mitigating risks associated with rapid scale-up and increasing demand

Speakers:

Anna Kulesza

CMC Program Lead

Telix Pharmaceuticals