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].

Sep 03, 2019
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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

Speaker:

Jon A. Rowley, PhD
Founder and Chief Product Officer
RoosterBio Inc. (MD, USA)

Jon Rowley is Founder and Chief Product Officer of RoosterBio Inc. (MD, USA). Jon started RoosterBio in 2013 as part of his personal quest of having the biggest impact possible on the commercial translation of technologies that incorporate living cells, including cellular therapies, engineered tissues and tomorrow’s medical devices. Jon holds a PhD from the University of Michigan (MI, USA) in Biomedical Engineering and has authored over 30 peer reviewed manuscripts and 20 issued or pending patents related to biomaterials development, tissue engineering and cellular therapy.  He has given keynote presentations at major cell therapy manufacturing conferences and delivered more than 75 conference presentations.

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