Xiangming Li
CMC Leader, Bioprocess Development Cartesian Therapeutics
Xiangming Li, PhD, is Associate Director of Bioprocess Development in Process Development and Manufacturing Science & Technology (PD & MS&T) for the mRNA CAR-T platform at Cartesian Therapeutics. He focuses on developing and optimizing manufacturing processes to support the advancement of next-generation cell and gene 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. He completed his PhD at Kansas State University and conducted postdoctoral research 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
