Addressing ADC Regulatory Strategy for Gross Content Testing, Linker RSM Definition & Alternative Charge Variant QC for Release & Stability
- Overviewing a late stage ADC case study with a pragmatic workaround of Gross Content Testing to ensure reliable assessment without traditional testing
- Understanding regulatory strategy for defining and justifying RSMs for ADC linker-payloads
- Explaining an alternative to the conventional QC approach for charge-variant profiling of ADC drug substance and drug product for release and stability