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The companies will collaborate the manufacture of personalized cancer vaccines.
On Oct. 13, 2016 Catalent Pharma Solutions announced that it has entered into an agreement with Moderna Therapeutics to support near-term clinical GMP messenger RNA (mRNA) manufacturing efforts for Phase 1/2 clinical studies. The clinical studies will focus on Moderna’s mRNA personalized cancer vaccines.
Moderna is working in collaboration with Merck to advance mRNA-based personalized cancer vaccines for patients across a spectrum of cancers. Clinical studies of of the vaccines are expected to begin in 2017. Under the terms of the agreement, in place through 2018, Moderna will leverage Catalent’s manufacturing capabilities at its facility in Madison, Wisconsin, to support cGMP manufacturing of its mRNA personalized cancer vaccine clinical studies while the company builds out and transitions to its recently announced GMP mRNA clinical manufacturing facility in Norwood, Massachusetts.
Completed in June 2013, Catalent’s Madison facility was designed for both flexible cGMP and non-GMP production. The site features single-use technologies and unidirectional flow to maximize efficiency and safety.