Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Catalent, Inc., the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced the expansion of their strategic collaboration to dedicate a new high-speed vial filling line for the manufacture of the Moderna COVID-19 Vaccine and potentially other investigational programs in Moderna’s pipeline, at Catalent’s biologics facility in Bloomington, Indiana.
In June 2020, Catalent and Moderna announced that Catalent would provide aseptic vial filling and packaging from its Bloomington site, including additional staffing required for 24×7 manufacturing to support production of an initial 100 million doses of Moderna’s vaccine. On March 29, Moderna announced that this significant milestone was achieved.
As part of this expanded agreement, Catalent will now dedicate to Moderna’s use a new high-speed filling line at the site through June 2023, which can be used to manufacture the COVID-19 vaccine and potentially additional investigational programs in Moderna’s large clinical pipeline. Catalent will also provide inspection, labeling, cartoning, and final packaging for these programs.
“We appreciate this expanded collaboration with Catalent and the dedication of their team,” said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. “This additional fill-finish capacity will be important for not only our COVID-19 vaccine, but also potentially for other programs in our clinical development pipeline.”
“Catalent’s partnership with Moderna began in 2016, when we had only glimpsed the potential applications of mRNA and could not have guessed how pivotal mRNA would become in the fight against COVID-19,” commented Alessandro Maselli, Catalent’s President and Chief Operating Officer. “We are proud to announce this extension of our companies’ strategic collaboration, and we look forward to further demonstrating our commercial manufacturing expertise as we help supply more vaccine doses.”
Catalent announced in September 2020 its $50 million investment into this third high-speed vial filling line at Bloomington. Due to the company’s considerable experience in facility and capacity expansion, it was able to accelerate the overall project from a typical 18-month timeframe to approximately 10 months, including construction, procurement, installation, and CGMP qualification of the line, which will be completed in April 2021. Furthermore, the ability to dedicate this new line to Moderna will enable the site to free-up capacity on existing lines for other important customer programs.