Moderna, a clinical-stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, and Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced a collaboration for large-scale, commercial fill-finish manufacturing of Moderna’s mRNA-based Covid-19 vaccine candidate (mRNA-1273) at Catalent’s biologics facility in Bloomington, Indiana.
As part of the agreement, Catalent will offer vial filling and packaging capacity and additional staffing required for 24×7 manufacturing operations at the site to support the production of an initial 100 million doses of the vaccine candidate intended to supply the US market starting in the third quarter of 2020. The companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses.
According to the press statement, Catalent will also offer clinical supply services from its plants in Philadelphia, Pennsylvania, including packaging and labeling, as well as storage and distribution to support Moderna’s Phase 3 clinical study for this candidate.
“We appreciate this collaboration with Catalent and the flexibility of their team to deliver critical fill-finish capacity for mRNA-1273 at unprecedented speed,” said Juan Andres, Moderna’s chief technical operations and quality officer. “It has been wonderful to see both teams working together to support the common good.”
“Catalent is proud to partner with Moderna in its work to address this critical public health need,” commented John Chiminski, chair and chief executive officer of Catalent. “Catalent’s proven expertise in manufacturing scale-up and commercial production are well suited to support Moderna’s efforts to prepare for a wide-scale supply of this vaccine candidate so that it is available if appropriate to address the pandemic.”
Catalent’s state-of-the-art 875,000 square-foot biologics plant in Bloomington will undertake this vial filling work under barrier isolator technology. Moderna will leverage the site’s recent packaging expansion, which offers fully automated and high-speed packaging capabilities to accelerate manufacturing timelines. The plant 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. In addition to its Bloomington location, the Catalent Biologics network has plants in Brussels, Belgium and Anagni, Italy that perform sterile drug product manufacturing and packaging, and in the United States and Europe for manufacturing proteins, viral vectors for gene therapies and cell therapies, as well as offering pre-filled syringe manufacture and biologics analytical services.