Rapid Clinical Translation and Scale-Up of hMSCs and hMSC-EVs

This webinar explores strategies for accelerating development, manufacturing, and commercialization of mesenchymal stem/stromal cell (MSC) and MSC-derived extracellular vesicle products. Topics include manufacturing scale considerations, cost-of-goods drivers, quality systems, process development planning, and approaches for transitioning from research-scale production to clinical manufacturing. The presentation discusses standardized cell banking, media systems, robust characterization methods, and scalable bioprocess platforms, including Vertical-Wheel bioreactors. Examples are provided illustrating improvements in productivity, consistency, and manufacturing efficiency across multiple production scales. The webinar also addresses emerging opportunities in MSC-derived EV therapeutics and highlights the importance of reproducible processes, quality control, and commercially relevant manufacturing strategies that support translational regenerative medicine programs.