RoosterBio and GenCure Sign Multiple Agreements to Advance Regenerative Medicine Startups

April 10, 2019

Multiple deals signed that leverage Plug&Play cGMP hMSC systems across med tech and synthetic biology segments of the regenerative medicine industry.

gencure_biomanufacturing_centerRoosterBio Inc. and GenCure, both regenerative medicine manufacturing technology leaders, have locked into multiple agreements to help companies advance their innovations to clinical testing more rapidly than ever before. Companies across the regenerative medicine industry, ranging from synthetic biology companies that are gene editing therapeutic cells for advanced functionality in vivo, to pioneering medical device companies that bridge the regenerative capabilities of living cells with medical devices, have signed agreements to accelerate their path to clinical testing. These companies are leveraging RoosterBio’s human mesenchymal stem/stromal cell (hMSC) bioprocess systems and rapid product and process development platform, and GenCure’s current Good Manufacturing Practices (cGMP)-compliant hMSC-focused manufacturing facility.

RoosterBio and GenCure’s one-of-a-kind industry partnership was established in 2017, marrying RoosterBio’s leading regenerative medicine manufacturing platform for hMSCs with BioBridge Global’s manufacturing (via GenCure) and testing capabilities. Leveraging this collaboration enables companies to shorten their cell therapy product and process development timelines, simplify technology transfer into cGMP manufacturing, and develop commercially viable cost structures for innovative cell and gene therapy products.

“These signed agreements illustrate how the regenerative medicine field is accelerating in both technology and development pace, promising multiple waves of novel therapeutic approaches cresting in the coming years,” said RoosterBio Founder and Chief Product Officer Jon A. Rowley, PhD.

There were 743 documented advanced cell therapy clinical trials initiated globally in 2018 alone according to celltrials.org. “The fields of synthetic biology & gene editing are evolving to take cellular therapies to the next level by bringing advanced controls to the complex therapeutic environments,” added Rowley. “As the medical device technology segment is rapidly moving towards incorporating living cells into next generation products, RoosterBio and GenCure’s customers are forward engineering their products in ways not possible just a few years ago, and rapid implementation in clinical testing to de-risk new business models and therapeutic approaches is of utmost importance to the field, and investors. The field is now seeing more rapid turnaround in the testing of new products using truly convergent technologies.”

Under the terms of of these newly signed agreements, RoosterBio will apply its breakthrough CliniControl™ hMSC manufacturing platform to be the preferred provider of their customer’s external development work for hMSC supply and expansion, including bioreactor scale up and industrialized large scale manufacturing unit operations. GenCure has completed the technology transfer of RoosterBio’s bulk hMSC expansion processes and and will be performing cGMP manufacturing and release testing of clinical doses of cells, and is prepared to support regulatory filings to reduce timelines, costs, and complexity of the regulatory process.

“Our joint collaboration with GenCure and our customers reflects the importance of strategically positioned technology platforms, cGMP manufacturing and testing, and therapeutic business models that are designed for rapid implementation,” said Dr. Rowley. “We are excited to see RoosterBio’s value propositions of radically simplifying hMSC product development, process development and clinical manufacturing being leveraged to move this field forward.”

Senior Vice President for BioBridge Global & Chief Operating Officer for GenCure Becky Cap said, “GenCure understands the challenges encountered when translating cellular therapies for clinical use, especially when it comes to cGMP-compliant manufacturing and testing.” She added, “Our specialized services in hMSC contract manufacturing will help smooth the transition for our customers.”

RoosterBio’s proprietary, clinically-relevant product portfolio manufactured by GenCure was introduced in 2017 under the CliniControl™ brand name with the promise to radically simplify multiple steps in therapeutic development, allowing product developers to remove years of time and millions of dollars from their development timelines. To date, CliniControl is the first hMSC products to be commercialized as off-the-shelf, cGMP-compliant working cell bank and bioprocess media systems. RoosterBio products are being used by several companies working with hMSCs in the gene editing, extracellular vesicles, tissue engineering, medical device, and cell therapy market segments.

Rowley added, “We’ve shown that our CliniControl products can uniquely deliver on the regenerative medicine industry needs and continue to drive unparalleled efficiencies and economies of scale in clinical and commercial hMSC manufacturing, helping our customers accelerate development of exciting new regenerative medicine products.”