Rapid Clinical Translation and Scale-Up of hMSCs and EVs
Discover novel innovations in MSC manufacturing and EV production that are leading to new product concepts and treatment modalities in our latest webinar on Wednesday 25 September 2019, 08:00 [PDT] 11:00 [EDT] 16:00 [BST].
Date: Wednesday 25 September 2019
Time: 08:00 [PDT] 11:00 [EDT] 16:00 [BST]
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)