Designing Potency Strategies for Dual-Payload ADCs to Determine if a Single Holistic Assay Is Sufficient or if Orthogonal Methods Are Required
- Implement a single cell-killing assay where the combined effect is the primary driver of efficacy to simplify the control strategy and provide a direct measure of potency, streamlining development and validation for late-stage and commercial control
- Developing two orthogonal assays when it is critical to monitor each payload’s function independently, ensuring consistent quality and function of both therapeutic components
- Use mechanism-specific inhibitors or engineered resistant cell lines in bioassays to determne the contribution payload within a single assay, gaining deep product understanding without the resource burden of developing and validating separate methods