Sarah Shi
Global Director, Regulatory Affairs CMC BeOne Medicines
Seminars
Monday 12th October 2026
Evaluating Impurity Qualification Requirements for Linker-Payload Related Impurities Used to Generate ADCs
10:00 am
- 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
