Mike Riley, VP and General Manager of Catalent Biologics confirmed that the company will be providing cGMP manufacturing of Moderna’s mRNA personalized cancer vaccine for phase I/II clinical studies.
According to the company, clinical study of the vaccine is expected to begin in 2017.
“Under the agreement, Catalent will be providing dedicated production capability to accommodate Moderna’s proprietary production process, and support fast turnaround of clinical material,” Riley told us.
Work will take place at Catalent’s Madison, WI-based facility, which was opened in 2013 to support both flexible cGMP and non-GMP production.
“The site features integrated process development and analytical capabilities, including the support of method development, in-process, release and stability testing,” said Riley.
Additionally, Catalent recently announced an expansion to the facility, which Riley said will create increased capacity for later phase clinical and commercial production.