Sarah Shi
Seminars
Monday 12th October 2026
Presentation Preview: Evaluating Impurity Qualification Requirements for Drug-Linkers Related Impurities Used to Generate ADCs
- Evaluating conjugatable impurities in ADC drug-linkers for potential toxicological risks
- Drug-linker conjugatable impurities present at ≤1.0% weight/weightare unlikely to pose a risk to patients
- Contextualizing how data provides science-based justification to increase qualification limit from 0.15% to 1.0% weight/weightfor DL intermediates
