Ensuring Comparability Across Clinical Phases to Achieve Commercial Success with Relma-cel CAR-T Therapy
9:00 am - Wednesday 15th July 2026
- Implementing phase-appropriate comparability strategies from phase one through phase three to maintain product consistency while transitioning from manual to automated processing
- Navigating critical process changes including automation of culture operations to balance regulatory expectations with commercial manufacturing scalability and cost effectiveness
- Establishing robust comparability frameworks early in development to prevent late-stage regulatory setbacks when integrating closed automated systems for commercial transition
