A human patient has been dosed for the first time with a drug that was made using a Frederick cell manufacturing platform company’s technology.
RoosterBio Inc. announced that its CliniControl cell and media systems were used to make the drug for clinical research by a customer it would not identify to The Daily Record.
It’s the first time standardized off-the-shelf cellular materials and associated scalable biomanufacturing has been used in regenerative medicine therapeutic products, according to RoosterBio.
Margot Connor, CEO of RoosterBio, said in a news release that the development will fuel the rapid commercialization of scalable regenerative cures.
The company now has five customers that the FDA has authorized to cross-reference Roosterbio’s master files for the system as they develop their own products. That lets them simplify and quicken product development, the company said.
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