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Catalent biologics to support Moderna clinical mfg.

Catalent Pharma Solutions has entered into an agreement with Moderna Therapeutics to support near-term clinical Good Manufacturing Practice (GMP) messenger RNA (mRNA) manufacturing efforts for Phase 1/2 clinical studies of the company's mRNA personalized cancer vaccines. Moderna, in collaboration with Merck, is advancing mRNA-based personalized cancer vaccines for patients across a spectrum of cancers. Clinical study of the personalized cancer vaccine is anticipated to begin in 2017.

Under the agreement, in place through 2018, Moderna will leverage Catalent's manufacturing expertise and capabilities at its facility in Madison, WI, to support cGMP manufacturing of its mRNA personalized cancer vaccine clinical studies while the company builds out and transitions to its GMP mRNA clinical manufacturing facility in Norwood, MA.

"We are extremely pleased to be selected to support Moderna's Phase 1/2 clinical GMP manufacturing needs for its personalized cancer vaccines," said Brian Riley, general manager of Catalent's Madison facility. "At the Madison facility, we will be able to offer Moderna a separate dedicated production capability and a highly flexible, fast turnaround operation to support initial study of its novel mRNA-based personalized cancer vaccines."

Catalent's Madison facility was designed for cGMP and non-GMP production, and features single-use technologies and unidirectional flow to maximize efficiency and safety.

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Title Annotation:INDUSTRY NEWS
Publication:Contract Pharma
Date:Nov 1, 2016
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