Building an ADC Comparability Bridge to Create a Strategic Framework for Successful Regulatory Submissions
- Implement a holistic comparability strategy that integrates mass spectrometry-based characterization with forced degradation studies, to move beyond a checklist of attributes and identify critical quality shifts
- Develop a risk-based comparability protocol focused on novel ADC-specific attributes to prioritize patient safety and mechanism of action, for faster regulatory approval
- Structure the comparability report as a compelling scientific story linking analytical data to clinical impact, to transform complex datasets into a clear demonstration of product understanding and control, increasing reviewer confidence