CMC Icos will be responsible for process development, manufacturing scale-up and current good manufacturing practices (cGMP) manufacturing of GGF2. Acorda plans to use the supply of GGF2 produced by CMC Icos for continued toxicology studies and early phase clinical trials.
Andrew Blight, chief scientific officer of Acorda, said: “We anticipate filing an investigational new drug application to the FDA for GGF2 in late 2009. We chose to work with CMC Icos because of their extensive expertise in cell culture and analytical methods in biologics manufacturing, and look forward to a productive partnership.”