Designing Comparability Strategies at Different Phases of ADC Development to Refine Assessments
Time: 1:15 pm
day: Day Two
Details:
- Identifying critical attributes (e.g., potency, pharmacokinetics, immunogenicity) that should be prioritized at each phase of ADC development to ensure meaningful comparability assessments
- Exploring tailored analytical approaches, such as early-phase screening versus latephase detailed characterization, to balance depth of analysis with project timelines and regulatory needs
- Discussing strategies to manage variations in manufacturing or formulation changes while ensuring consistent comparability results, meeting regulatory expectations for continuity and safety
