Osama Charhrour
Director & Principal Scientist - Chemical Development & New Modalities AstraZeneca
Seminars
Wednesday 25th February 2026
Improving Qualification Requirements for Drug-Linker Related Impurities Used to Generate ADCs
11:00 am
- Issuing guidance for industry sponsors and regulatory agencies to assess safety of impurities in ADC drug-linker intermediates
- Evaluating conjugatable impurities in ADC drug- linkers for potential toxicological risks for all clinical stage and approved ADCs
- Developing a methodology to assess the level of concern and justify specifications for non- conjugatable organic impurities
- Qualification divergence: drug-linker impurities versus small molecule API impurities
