Navigating the Complexity of a Phase-Appropriate Framework for Potency Assay of Bispecific ADCs at IND
- Develop antigen-binding assays to verify the structural integrity of bispecific molecules, ensuring both binding arms remain functionally intact, and the product retains its intended activity
- Apply a strategic cell line selection approach for cytotoxicity assays to develop a physiologically relevant bioassay that accurately models the MoA of ADCs
- Optimize and streamline bioassay method transfer from ARD to QC to accelerate implementation while ensuring robustness, reproducibility, and regulatory compliance