Roundtable Discussion: Defining CQA-Driven Specifications to Guide Scalable & Phase-Appropriate ADC Process Development
Time: 1:00 pm
day: Day One
Details:
- Identifying how setting realistic, phase-appropriate specifications can streamline scale-up
- Exploring how factors such as conjugation heterogeneity and stability impact specification limits at larger scale
- Discussing what can be deferred vs. what must be locked down from early phase onward
