Catalent, Moderna Therapeutics in Pact for Personalized Vaccines
Catalent Pharma Solutions has entered into an agreement with Moderna Therapeutics, a Cambridge, Massachusetts-based biotechnology company focusing on messenger RNA (mRNA) therapeutics, to support near-term cGMP mRNA manufacturing efforts for Phase I/II clinical studies of Moderna’s mRNA personalized cancer vaccines.
Under the agreement, which is in place through 2018, Moderna will leverage Catalent’s manufacturing expertise and capabilities at Catalent’s facility in Madison, Wisconsin to support cGMP manufacturing of Moderna’s mRNA personalized cancer vaccine clinical studies while Moderna 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.
Moderna, in collaboration with Merck & Co., 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.
Source: Catalent Pharma Solutions