2:00pm Roundtable Discussion: Discussing Best Practices for ADC Process Validation & Comparability
Time: 2:00 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 comparability requirements for ADCs with druglinkers from different sources to meet regulatory expectations
- Discussing strategies for evaluating small molecule impurity clearance and establishing robust purge factor calculations
