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