Human mesenchymal stem/stromal cells (hMSCs) and extracellular vesicles (hMSC-EVs) are leading platforms for development of regenerative medicine therapies. Multiple bottlenecks exist during discovery, product development, manufacturing process development and cGMP manufacturing, leading to timelines from discovery through first-in-man testing often averaging 7-11 years. This webinar discusses novel hMSC bioprocess systems that are designed for rapid process development and cGMP tech transfer to radically reduce development timelines to as little as 2-4 years. Requirements for implementation of bioreactor systems will also be addressed, and data will be presented from 50L scale microcarrier-based processes with critical quality attributes for both hMSCs and EVs.
What will you learn?
• Novel innovations in MSC manufacturing and EV production that are leading to new product concepts and treatment modalities
• Estimated development costs and timeline of cGMP manufacturing at different scales
• MSC manufacturing methods in use today that reduce time to first-in-man testing 2-3 fold, from an estimated 7-11 years to as little as 3-4 years
• MSCs as a production platform for EVs
• With a record 164 MSC-involved clinical trials initiated in 2018 alone, the MSC paradigm is expanding to include gene modified cells, MSC-sourced exosomes or EVs, engineered tissues and organs, and combination medical devices
Who may this interest?
• Persons actively involved in the development of clinical cell therapies and regenerative medicine
• Those working with, or considering working with, MSCs at scale
• Scientists and clinicians investigating exosomes and EV production methods
• Gene therapy and medical device product developers
• Cosmeceutical product developers
Jon A. Rowley, PhD
Founder and Chief Product Officer
RoosterBio Inc. (MD, USA)