Time

Topic

14:00-14:45

CMC Regulatory Consideration on Biologics Development

Tina Yu, Sr. Director of Regulatory Affairs Dept., ProBio

• Overview of pharmaceutical regulatory systems 
• CMC regulatory considerations for Phase I clinical trials
• Changes management during clinical trials
• CMC work scope for the late-stage development (BLA/MAA)
• Case study on regulatory life-cycle management for a new drug

14:45-15:30

Challenges and Solutions for Complex Biologics CMC

Ying Li, Director of Antibody R&D and Purification PD Dept., ProBio

Discuss cell line, cell culture and purification development strategy for the following key challenges in CMC:

• Product expression improvement
• Homodimer control and removal
• Aggregate control and removal
• N-Glycan optimization

15:30-16:15

Enhancing Technology Transfer: Strategies, Challenges, and Best Practices

Xue Jin, Sr. Scientist of Antibody PD and MSAT Dept., ProBio

• Effective approaches to tech transfer
• Key challenges and pain points in tech transfer
• Case studies sharing
• Tech transfer in PPQ