Presented By: Biomedical Engineering
BME 500: Jon Rowley, Ph.D.
“Radically Simplifying hMSC Manufacturing Scale-up and Regenerative Medicine Product Development (and Building a Business around Regenerative Medicine Manufacturing Technology)”
BME 500 Seminar Series
Thursday, October 3rd, 2019
9:00 – 10:00 a.m.
133 Chrysler
Jon Rowley, Ph.D.
Founder of RoosterBio Inc.
University of Michigan Alumnus
“Radically Simplifying hMSC Manufacturing Scale-up and Regenerative Medicine Product Development (and Building a Business around Regenerative Medicine Manufacturing Technology)”
Abstract:
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. RoosterBio has developed and commercialized 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 scalable bioreactor production systems will also be addressed, and data will be presented from 50L scale microcarrier-based processes with CQAs for both hMSCs and EVs.
Thursday, October 3rd, 2019
9:00 – 10:00 a.m.
133 Chrysler
Jon Rowley, Ph.D.
Founder of RoosterBio Inc.
University of Michigan Alumnus
“Radically Simplifying hMSC Manufacturing Scale-up and Regenerative Medicine Product Development (and Building a Business around Regenerative Medicine Manufacturing Technology)”
Abstract:
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. RoosterBio has developed and commercialized 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 scalable bioreactor production systems will also be addressed, and data will be presented from 50L scale microcarrier-based processes with CQAs for both hMSCs and EVs.
