RoosterBio Commercializes Industry’s First cGMP Human Mesenchymal Stem Cell Banks For Widespread Manufacturing, Continuing To Revolutionize Regenerative Medicine
FREDERICK, Md. (PRWEB) January 25, 2018 -- RoosterBio.com, a leading manufacturer of adult, allogeneic human mesenchymal stem/stromal cells (hMSCs) and paired bioprocess media systems, continues to deliver on its mission to de-bottleneck and accelerate the Regenerative Medicine Industry by launching the only commercially-available working cell banks (WCBs) for large scale hMSC production. Introduced under the CliniControlTM Brand Name, these hMSC WCBs are manufactured to current Good Manufacturing Practices (cGMP) and conform to xeno-free (XF) guidelines, as outlined by the International Society for Cellular Therapies. CliniControl™ hMSCs are supported for use as a cellular starting material for therapeutic cell manufacturing by Quality and Regulatory documentation, which facilitates IND filings.
This next-generation product offering is a momentous paradigm shift in stem cell supply chain logistics. Globally, there are ~800 active hMSC clinical trials today (clinicaltrials.gov), and this number is increasing significantly year-over-year. To date, each organization seeking to run a clinical trial for a hMSC-based therapeutic has had to manufacture its own cell banks, creating great redundancy in the field. With CliniControl™ hMSCs, product developers bypass time-intensive and costly steps in Master and Working Cell Bank generation, characterization, testing and release, shaving years and millions of dollars from their development timelines. Implementation of CliniControl™ hMSCs establishes a streamlined, comprehensive, qualified stem cell supply chain, drastically reducing redundancy and driving greater capital efficiency across the Industry.
Together with RoosterBio CliniControl™ bioprocess medium (RoosterNourish™-MSC-CC) and manufacturing recommendations, CliniControl™ hMSCs will drive unparalleled efficiencies and economies of scale in clinical and commercial adult stem cell manufacturing.
“We are very excited to be launching these much needed and enabling products into the rapidly advancing Regenerative Medicine Industry. I am very proud of the entire team at RoosterBio for all the hard work and dedication that it took to bring these new innovations to market, in support of the RoosterBio vision – to radically accelerate the cell-based bioeconomy. Our current and future customers will be enjoying profoundly simplified pathways as they work to commercialize the therapies of tomorrow.” said Dr. Jon Rowley, Founder and Chief Technology Officer
To learn more about CliniControl™ products, please contact Priya Baraniak, PhD
About RoosterBio, Inc.:
RoosterBio.com,Inc. is a privately held stem cell tools and technology company focused on accelerating the development of a sustainable Regenerative Medicine industry, one customer at a time. RoosterBio’s products are high volume, affordable, and well-characterized adult human mesenchymal stem/stromal cells (hMSCs) paired with highly engineered media systems. RoosterBio has simplified and standardized how stem cells are purchased, expanded, and used in development, leading to marked time and costs savings for customers. RoosterBio’s innovative products are ushering in a new era of productivity and standardization into the field, accelerating the road to discovery in Regenerative Medicine. For more information on RoosterBio and adult stem cells, please visit http://www.roosterbio.com, follow on twitter (@RoosterBio), or read our corporate blog (http://www.roosterbio.blogspot.com).
Priya Baraniak, PhD, RoosterBio, http://www.RoosterBio.com, +1 301-600-1058 Ext: 304, [email protected]
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