Webinar - Navigating Biologics Challenges：Regulatory, Process Development, and Tech Transfer Solutions

As the biologics field rapidly evolves, mastering regulatory pathways, process development, and tech transfer is essential for success. Gain key insights to drive innovation and overcome challenges. This discussion will provide practical strategies to support your biologics development journey. Join our webinar on April 8th!

Tina Yu

Sr. Director

Regulatory Affairs Dept., ProBio

Ying Li

Director

Antibody R&D and Purification PD Dept., ProBio

Xue Jin

Sr. Scientist

Antibody PD and MSAT Dept., ProBio

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

00:00

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