Investigational New Drug (IND) Using RoosterBio’s CliniControl™ Products Enters the Clinic by RoosterBio’s Pharmaceutical Customer
FREDERICK, MD. (PRWEB) MARCH 04, 2020
RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cell (hMSC) working cell banks and hMSC bioprocess systems, announces today a significant milestone in the regenerative medicine field with the dosing of the first patient using its innovative cellular starting materials. The patient has been treated by RoosterBio’s pharmaceutical customer with an Investigational New Drug (IND) that was manufactured using RoosterBio’s CliniControl cell and media systems. This marks the first demonstration of standardized off-the-shelf cellular starting and ancillary raw materials and associated scalable biomanufacturing applied to regenerative medicine therapeutic products.
“The first-in-human clinical trial of our customer’s novel therapeutic manufactured using our CliniControl products is an important milestone and a key step to tangibly demonstrate RoosterBio’s commitment to helping our customers rapidly develop safe and effective regenerative medicine products,” said Margot Connor, CEO of RoosterBio. “More importantly, this platform advancement will fuel the rapid commercialization of scalable regenerative cures.”
The use of RoosterBio’s CliniControl products is supported by Type II Master Files (MF) which were submitted to the U.S. Food and Drug Administration (FDA) in 2017 for bioprocessing media and 2018 for hMSC banked vials. As a result, the FDA has on-file the proprietary chemistry, manufacturing and controls (CMC) information for RoosterBio’s starting cell banks and bioprocess media systems for simple referencing by its therapeutic sponsors.
RoosterBio now has five customers who have been granted authorization to cross reference both of its MFs as part of their customers’ clinical development. RoosterBio has radically simplified product development and shortened product development timelines by providing access to standardized, off-the-shelf, ancillary and cellular starting materials manufactured under current good manufacturing (cGMP) conditions for further manufacturing and regulatory compliancy. RoosterBio’s focus on industrializing the regenerative medicine supply chain ushers in a new era of productivity to the field.
Connor added, “We are excited to see RoosterBio’s vision of solving regenerative medicine product and process development challenges with innovative biomanufacturing strategies, continue to drive novel therapeutic approaches forward.”
About CliniControl™ Products
CliniControl cells and media are the first and only off-the-shelf, cGMP-produced human mesenchymal stem/stromal cells (hMSCs) and bioprocess media systems with accompanying Type II Master Files on record with the U.S. Food and Drug Administration (FDA). CliniControl products radically simplify the process of IND filing and clinical translation for Regenerative Medicine companies that utilize hMSCs within their manufacturing process.
About RoosterBio, Inc.
RoosterBio, Inc. is a privately held cell manufacturing platform 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 to the field, accelerating the road to discovery in Regenerative Medicine. For more information on RoosterBio, please visit http://www.roosterbio.com.
We are excited to see RoosterBio’s vision of solving regenerative medicine product and process development challenges with innovative biomanufacturing strategies, continue to drive novel therapeutic approaches forward