CHAPTER 21: Occupational Health and Safety Considerations for the Handling and Manufacture of Antibody–Drug Conjugate (ADC) Payloads

Antibody–drug conjugate (ADC) payloads are a relatively new class of potent and highly potent active pharmaceutical ingredients (APIs), with cytotoxic activities often in the low picomolar range, due to mechanisms of action that include tubulin inhibition and DNA cleavage, cross-linking or mono-alkylation. The ability to conjugate such payloads to antibodies to make ADCs, represents a new area in the field of targeted cancer chemotherapy. The very high cytotoxicity of some ADC payloads, requires their manufacture and handling to be carefully managed and worker health and safety protected. Parties handling these materials must apply a systematic and scientific approach to occupational health and safety, including toxicological hazard assessment, exposure risk assessment, engineering control/containment, occupational hygiene and related management systems.