Moderna & Catalent Announce Long-Term Strategic Collaboration for Dedicated Vial Filling of Moderna’s COVID-19 Vaccine & Clinical Portfolio

Moderna, Inc. and Catalent, Inc. recently 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, IN.

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,” added 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.

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past 6 years. To learn more, visit www.modernatx.com.

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs approximately 15,000 people, including over 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, NJ. For more information, visit www.catalent.com