Demystifying the Mechanism of Action & Designing Potency Assays That Truly Reflect ADC Biology to Establish a Clinically Relevant & Meaningful CQA
- Deconstruct the ADC’s mechanism into discrete steps to identify biologically relevant activity to measure for potency assays, ensuring the method reflects the product’s therapeutic function
- Select or engineer a cell line that accurately expresses the target antigen to create a bioassay that is specific and responsive to the ADC’s activity, enabling reliable potency methods that detect changes in product quality
- Incorporating effector function assays when they are part of the intended MoA to fully capture the multifaceted activity of the ADC, providing a complete picture of potency for molecules designed to engage immune cells