Manufacturing Alliance Created for Personalized Cancer Vaccines

Catalent Pharma Solutions recently entered into an agreement with Moderna Therapeutics to support messenger RNA manufacturing.

Catalent provides delivery technologies and develops solutions for drugs, biologics, and consumer health products, and Moderna is a biotechnology company that creates messenger RNA (mRNA) drugs.

The manufacturing agreement will aid efforts to create mRNA personalized cancer vaccinations for phase 1/2 clinical trials, according to a press release from Catalent. Moderna is also collaborating with Merck to create these personalized vaccines for a multitude of cancer types. Clinical trials are expected to start in 2017.

The collaboration with Merck uses Moderna’s mRNA vaccine technology to encode a patient’s cancerous mutation, combining it with Merck’s cancer drug Keytruda (pembrolizumab). According to Moderna, the vaccines created will elicit a specific immune response that recognizes and destroys cancer cells.

This personalized approach will be able to tailor a patient’s treatments to their mutations to receive the optimal therapy. Under the most recent agreement, Catalent will manufacture the mRNA vaccines at their facility in Wisconsin.

This facility was created for both flexible clinical Good Manufacturing Practice and non-Good Manufacturing Practice (GMP) production, according to the press release.

“We are extremely pleased to be selected to support Moderna’s Phase 1/2 clinical GMP manufacturing needs for its personalized cancer vaccines. Catalent’s Madison facility was designed and constructed to offer maximum flexibility and efficiency,” said Brian Riley, General Manager of Catalent’s Madison facility. “At the 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.”