SOMERSET, N.J.–(BUSINESS WIRE)–Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today 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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About Catalent Cell & Gene Therapy
Catalent Cell & Gene Therapy is a full-service partner for adeno-associated virus (AAV) vectors and CAR-T immunotherapies, with deep experience in viral vector scale-up and production. Catalent recently acquired MaSTherCell, adding expertise in autologous and allogeneic cell therapy development and manufacturing to position Catalent as a premier technology, development and manufacturing partner for innovators across the entire field of advanced biotherapeutics. Catalent has a global network of clinical and commercial manufacturing facilities, and fill-finish and packaging capabilities located in both the U.S. and Europe. Catalent Cell & Gene Therapy has produced more than 100 cGMP batches across 70+ clinical and commercial programs. For more information, visit biologics.catalent.com/cell-gene-therapy/
Catalent, Inc. (NYSE: CTLT) 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 over 13,500 people, including over 2,400 scientists and technicians, at more than 40 facilities, and in fiscal year 2019 generated over $2.5 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com
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Statements concerning the development, success, and administration of clinical trials, ability to launch, and future manufacturing contained in this release are forward-looking statements. They involve known and unknown risks, uncertainties, and other factors that may cause actual results or performance to be different from those expressed or implied in this release. Catalent has based its forward-looking statements on its current expectations, assumptions, estimates and projections, which it believes to be reasonable, but various factors, including factors beyond Catalent’s control, may affect future results or performance. Among the factors that may affect these forward-looking statements are: the rapidly changing market for treatments and vaccines to address the COVID-19 pandemic, the current or future effects of the COVID-19 pandemic, including its effects on Catalent’s and its clients’ businesses, the outcome of the development of this or any competing vaccine or any treatment for COVID-19, the outcome of any and all reviews, inspections or other approvals by the U.S. Food and Drug Administration (FDA) or similar regulatory health authority, customer, and payor acceptance of the proposed vaccine, any competing vaccine, or any treatment for COVID-19, competitor responses to a potential future launch of this vaccine, changes to the overall economic climate in the regions where this product may be marketed or among potential purchasers of the product, changes to the healthcare reimbursement system in the regions where this product may be marketed or elsewhere, competing initiatives at Catalent or AstraZeneca, supply chain risks relating to the vaccine, fluctuations in currency exchange rates that affect Catalent’s ability to source the materials needed for the production of the product, or potential third-party claims or litigation related to the vaccine. These and other important factors, including those discussed under “Risk Factors” in the Catalent, Inc. Annual Report on Form 10-K for the year ended June 30, 2019 or its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, may affect future results or performance. Catalent makes the statements in this release only as of the date of this release, and Catalent disclaims any duty, except as required by law, to update or revise any forward-looking statement, regardless of the circumstances.