Yun Bai

Company: Santa Ana Bio

Job title: EVP of CMC

Seminars:

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 onwardRead more

day: Day One

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 othersRead more

day: Day One