ADC CMC Excellence: Navigating Phase-Appropriate Regulatory and Analytical Strategies through CDMO-Biotech Collaboration
Time: 12:00 pm
day: Day One
Details:
- Analytical Excellence: Strategies for analytical and regulatory quality in building the analytical approach
- Phase-Specific Strategies: Striking a balance between early-phase flexibility and late-phase compliance, with a focus on robust impurity control strategies
- CDMO-Biotech Integration: key considerations in technology transfers and development approaches
