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 drug-linker intermediates used to produce ADCs in oncology
- 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