Evaluating Impurity Qualification Requirements for Linker-Payload Related Impurities Used to Generate ADCs

• Evaluating conjugatable impurities in ADC linker-payloads for potential toxicological
• Linker-payload conjugatable impurities present at ≤1.0% weight/ weight are unlikely to pose a risk to
• Contextualizing how data provides science-based justification to increase qualification limit from 0.15% to 1.0% weight/weight for linker-payload intermediates

Speakers:

Sarah Shi

Director, Global Regulatory Affairs CMC

BeOne Medicines