Yun Bai
Seminars
Wednesday 22nd October 2025
Roundtable Discussion: Defining CQA-Driven Specifications to Guide Scalable & Phase-Appropriate ADC Process Development
1:30 pm
- 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
Wednesday 22nd October 2025
Development & Manufacturing Strategies for an ADC With Novel Payload for Clinical Evaluation
1:00 pm
- Introduction of a new ADC class with steroid payload
- Discussing unique development and manufacturing challenges for ADC with steroid payload
- Reviewing a case study in PD, quality, stability, in vitro and in vivo efficacy, among others
