Potency Assay Development for a Novel ADC modality: A Phase-Appropriate Strategy
- Design and qualify an early-phase, MoA-relevant cell-based potency assay – capturing target binding, internalization, and payload-driven response.
- Adopt linear regression to model the concentration-response relationship — reducing bias and enabling accurate potency estimates across the working response range.
- Identify and resolve key technical challenges to ensure late-phase readiness for the selected candidate.