Workshop highlights include:

  • Breaking down the end-to-end playbook for drug-linker CMC development including: specifications and impurity control strategy, comparability, process development and validation, stability, and post-approval changes 
  • Delving into framework for purge factor calculations and experimental evaluation of clearance of small molecule impurities in the ADC drug substance manufacturing process
  • Exploring ADC IND and BLA filing strategies and recommendations per the ICH M4Q (R2) framework

Workshop Presented By IQ Consortium Working Group