Improving Qualification Requirements for Drug-Linker Related Impurities Used to Generate ADCs

• 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

Speakers:

Osama Charhrour

Principal Scientist, Chemical Development

AstraZeneca