1:30pm Shaping Best Practices for ADC Process Validation & Comparability
Time: 1:30 pm
day: Day One CMC Track
Details:
- Exploring industry approaches to process validation and comparability for ADCs, including key attributes for drug-linker and drug substance release specifications
- Discussing challenges in demonstrating comparability for ADCs with drug-linkers from different sources and strategies to meet regulatory expectations
- Sharing experiences from global ADC programs to identify best practices for ensuring process consistency and regulatory alignment
