Strategic & Data Driven Controls for Antibody- Drug Conjugates with Multiple Mechanisms of Action

Time: 1:30 pm
day: Track C - Day 2 PM


  • Designing a control strategy for an ADC with multiple mechanisms of action requires a strategic and data driven approach
  • The control strategy should directly link critical quality attributes to the process utilizing product and process characterization
  • Proper controls at the appropriate steps throughout the mAb, DS, and DP manufacturing process ensures a holistic and integrated control strategy