Platform Characterization & Risk Assessment of a Payload–Linker Related Variant in ADCs
- Implement a platform analytical strategy using orthogonal methods to structurally characterize a recurring payload-linker, enabling proactive risk assessment and establishing a platformwide control strategy
- Conduct forced degradation studies and spiking experiments to model the variant’s behavior to quantify the kinetic formation rate of the variant and provide critical data to justify setting appropriate specification limits