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RoosterBio, a stem cell tools and technology supplier with a focus on regenerative medicine, announced the 4Q18 submission of an FDA Type II Master File (MF) for its CliniControl™ line of cGMP human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks.
According to the company, these are the first hMSC products to be commercialized as off-the-shelf, cGMP-compliant hMSC working cell banks and bioprocess media systems with accompanying MFs. RoosterBio’s CliniControl products are designed to simplify clinical translation for regenerative medicine-focused companies that use hMSCs in their manufacturing processes.
This MF complements the company’s previously submitted MF for the CliniControl RoosterNourish™ MSC-CC bioprocess media, filed in 2017. These MFs contain information on the products including their chemistry, manufacture and controls. The MFs enable RoosterBio to protect proprietary product information while allowing FDA to review the information in support of an investigator’s submission.
Upon request, RoosterBio will grant customers authorization to cross reference the stated MF(s) to support their own regulatory filing, such as an Investigational New Drug application to FDA.
“RoosterBio’s CliniControl products—with accompanying MFs—represent a significant company milestone and are a meaningful advancement for the industry,” said Jon Rowley, Ph.D., Founder and Chief Product Officer for RoosterBio. “The regulatory work that we have taken out of our customers’ hands demonstrates our dedication to reducing the time it takes to get life-saving regenerative medicine products into the clinic, and onto the market.”
Source: RoosterBio
