In the Press
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In the Press |
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Date: 22nd April 2008 Title: CMC Icos Biologics, Farmaceutici Formenti SPA, Florida Biologix and JR Scientific have all recently announced new contract manufacturing developments. Biotechnology firm Acorda Therapeutics and
contract manufacturer CMC Icos Biologics have entered an agreement whereby
the latter will produce GGF2, the lead molecule in Acorda's neuregulin
program. In preclinical studies, neuregulins have
demonstrated potential for neurological protection in a number of
indications, including models of multiple sclerosis (MS) and stroke, the
firm said. From its recently acquired facilities in
Seattle, CMC Icos will be responsible for the process development,
manufacturing scale-up and current good manufacturing practices (cGMP)
manufacturing of GGF2. Acorda said it will use the supply of GGF2 for
continued toxicology studies and early phase clinical trials, the results
of which it plans to use to file an investigational new drug (IND)
application to the US Food and Drug Administration (FDA) for GGF2 in late
2009. "Scaling up and validating the manufacturing
process of this compound is an important step toward advancing GGF2 from
the lab to the clinic," said Andrew Blight, chief scientific officer of
Acorda. "We chose to work with CMC ICOS because of their extensive expertise in cell culture and analytical methods in biologics manufacturing."
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