Aseptic Manufacturing of Antibody-Drug Conjugates – From Process Development to Validation
1:03 pm - Wednesday 10th March 2027
- Despite frequently discussed challenges with respect to ADC complexity in development of analytics and bioconjugation processes, the challenges in the final steps – aseptic manufacturing of drug product (DP) has shared less spotlight
- The distinctive physicochemical properties from ADCs compared to naked antibodies also lead to special technical challenges in DP manufacturing, for example, the highly potent/ cytotoxic payload necessitates containment strategies to protect operators and environment; in most cases, ADCs need to be lyophilized due to their poor liquid stability; light exposure controls are often implemented to overcome restricted photostability
- This presentation will discuss the impacts from these challenges on DP process development, validation, manufacturing, and mitigations proposed to reduce risks
