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24 Aug 2020

Catalent expands manufacturing support for COVID-19 vaccine AZD1222

The company will prepare the Harmans facility to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing later this year.

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 the company's facility in Anagni, Italy, will provide large-scale vial filling and packaging of AZD1222.

The adenovirus vector-based vaccine candidate, AZD1222, which is currently in clinical trials, was co-invented by the University of Oxford and its spin-out company, Vaccitech, and licensed by AstraZeneca.

Catalent has significant experience in viral vector manufacturing. The company's Harmans/BWI commercial manufacturing facility is equipped with single-use technology, and houses more than 200,000 sq. ft (18,600 m2) 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.

Manja Boerman, President, Catalent Cell & Gene Therapy, said: “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.”

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