Aseptic Manufacturing of Antibody-Drug Conjugates – From Process Development to Validation
2:15 pm - Wednesday 10th March 2027
- The challenges in the final steps of aseptic manufacturing of ADC drug product (DP) has shared less spotlight
- Outlining technical challenges in ADC 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
- Discussing the impacts from these challenges on DP process development, validation, manufacturing, and mitigations proposed to reduce risks