Therapy Areas: Cardiovascular
Moderna and Catalent Team for Fill-Finish Manufacturing of Moderna's COVID-19 Vaccine Candidate
25 June 2020 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) and US-based delivery technologies, development, and manufacturing solutions provider Catalent, Inc. (NYSE: CTLT) have forged 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, the companies said.

As part of the agreement, Catalent will provide vial filling and packaging capacity, as well as additional staffing required for 24x7 manufacturing operations at the site to support production of an initial 100m doses of the vaccine candidate intended to supply the US market starting in 3Q20.

The companies are in discussions to secure fill-finish capacity for continued production of hundreds of millions of additional doses.

Catalent will also provide clinical supply services from its facilities in Philadelphia, Pennsylvania, including packaging and labeling, as well as storage and distribution to support Moderna's Phase 3 clinical study for this candidate.

Catalent's 875,000 square-foot biologics facility in Bloomington will undertake this vial filling work under barrier isolator technology.

Moderna will leverage the site's recent packaging expansion, which provides fully automated and high-speed packaging capabilities to accelerate manufacturing timelines.

The 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.

In addition to its Bloomington location, the Catalent Biologics network has facilities 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 providing pre-filled syringe manufacture and biologics analytical services.

mRNA-1273 is an mRNA vaccine candidate against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health.

On June 11, 2020, Moderna announced that enrollment of younger adults (n=300) and the sentinel group of older adults in its Phase 2 study of mRNA-1273 was complete, and that its Phase 3 study of approximately 30,000 participants, is expected to begin in July 2020.

Moderna is advancing messenger RNA science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.

The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates.

Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck and Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the US Department of Defense, and Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant secretary for Preparedness and Response within the US Department of Health and Human Services.

Moderna has been named a top biopharmaceutical employer by Science for the past five years.

Catalent is a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products.

Catalent employs over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over USD 2.5bn in annual revenue.
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