The new arrangement between the New Jersey-based CDMO and the vaccine maker follows completion of a deal inked in June last year in which Catalent agreed to provide aseptic vial filling and packaging to allow round-the clock production of an initial 100 million doses of the US biotech’s vaccine. This milestone was achieved at the end of last month.

Catalent’s Indiana facility has deep expertise in sterile formulation, with drug substance development and manufacturing and drug product fill-finish capacity across liquid and lyophilized vials, prefilled syringes and cartridges, as well as primary and secondary packaging.

The company’s new line will be reserved exclusively for Moderna up to the end of June 2023. The equipment can be used to manufacture the Covid vaccine as needed and potentially for additional investigational programs in Moderna’s large clinical pipeline.  Catalent will also provide inspection, labeling, cartoning and final packaging for these programs.

The CDMO announced plans for the $50 million investment in its third high-speed vial filling line in September last year, but said that thanks to its extensive experience in facility and capacity expansion it was able to accelerate the overall project from a typical 18-month timeframe to about 10 months.

Construction, procurement, installation and CGMP qualification of the line are scheduled to be completed this month. Dedicating this to Moderna will enable the site to free-up capacity on existing lines for other important customer programs, Catalent said.

The partnership between the two companies began in 2016, “when we had only glimpsed the potential applications of mRNA and could not have guessed how pivotal it would become in the fight against Covid-19,” Catalent’s president and chief operating officer, Alessandro Maselli, remarked.

Author: Dede Williams, Freelance Journalist