Xiangming Li
CMC Leader, Bioprocess Development Cartesian Therapeutics
Xiangming Li, PhD, is the CMC leader, currently serving as Associate Director of Bioprocess Development in Department of Process development and Manufacture Science for Cartesian Therapeutics. She focuses on developing and optimizing manufacturing processes to support the advancement of next-generation cell therapies. Prior to joining Cartesian Therapeutics, Dr. Li worked at GSK in vaccine and biologics development, contributing to mammalian expression technologies and early drug-substance CMC development for CHO-based platforms. She completed her PhD at Kansas State University and conducted postdoctoral fellowship at the University of Maryland School of Medicine.
Seminars
- Selecting vendors with proven capability to scale support from early clinical phases through commercial launch and beyond
- Conducting comprehensive due diligence to evaluate vendor reliability, regulatory compliance, and long-term partnership potential amid evolving market complexities
- Collaborating with automation vendors early in product development to influence their pipelines and ensure tools meet specific biotechnology requirements
This session is your opportunity to share your most pressing challenges, and work as a group to come up with solutions that you can implement right away. Each topic area will have two groups, and each group will have 30 minutes to discuss ways to overcome barriers. Groups will then share their findings with all attendees, giving you maximum exposure to new ideas!
Roundtable Discussion: Navigating Phase-Specific Regulatory Expectations to Align Process Development & Enable Seamless Commercial Progression
- Defining phase-appropriate characterization rigor, comparability strategies, and parameter lock timing to satisfy regulatory requirements while maintaining optimization flexibility
Roundtable Discussion: Defining In Vivo Cell Therapy Process Development Requirements & Comparing Manufacturing Paradigms to Traditional Ex Vivo Approaches
- Contrasting in vivo versus ex vivo cell therapy manufacturing workflows to identify unique process development challenges, including vector production and delivery systems
