Somerset-based Catalent, Inc., a global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that Catalent Cell & Gene Therapy will provide drug substance manufacturing to AstraZeneca for the University of Oxford’s adenovirus vector-based COVID-19 vaccine, AZD1222, at Catalent’s commercial gene therapy manufacturing facility located in Harmans, Maryland.
Catalent will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing late in the third quarter of 2020. This agreement expands Catalent’s support of the AZD1222 program following the announcement in June that Catalent’s facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.
The adenovirus vector-based vaccine candidate, AZD1222, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca. The vaccine candidate is currently in clinical trials.
“Catalent has significant experience in viral vector manufacturing,” commented Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. She added, “We are pleased to have the capabilities at our flagship Catalent Gene Therapy site to expand our support for the AstraZeneca program, while continuing to serve our current gene therapy customers. Our gene therapy team is proud to join our Catalent Biologics colleagues at the Anagni site in the advancement of AstraZeneca’s COVID-19 vaccine candidate.”
Catalent’s state-of-the-art Harmans/BWI commercial manufacturing facility is equipped with single-use technology, and houses over 200,000 square feet (18,600 square meters) of late-stage clinical and commercial-stage gene therapy production. The facility is one of Catalent’s five gene therapy facilities in Maryland providing clinical through commercial scale services, and houses multiple CGMP manufacturing suites, including fill/finish, central services and testing laboratories, warehousing, and supply chain capabilities. The Catalent Biologics network also includes sterile drug product manufacturing and packaging facilities in Anagni, Italy, Brussels, Belgium, and Bloomington, Indiana, with additional facilities in Europe and the United States for manufacturing proteins, cell therapies, and biologics analytical services.
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