Assessing Case Study Characterization & Control of an ADC Variant to Mitigate Analytical Comparability Risk
- Contextualizing case study of a new ADC impurity identified by reducing CE-SDS in late process development
- Delving into impurity characterization and process control to mitigate risk to ADC quality
- Recapping feedback from Health Authorities to assess if impurity presence was appropriately characterized to mitigate analytical comparability risk