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Catalent, Inc., global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, announced that Catalent Biologics will provide vial filling and packaging capacity to AstraZeneca PLC at Catalent’s manufacturing facility in Anagni, Italy, and prepare for large-scale commercial supply of the University of Oxford’s adenovirus vector based COVID-19 vaccine candidate, AZD1222.
The agreement accelerates the rapid scale-up of capacity over the coming months to support the dedicated production of AZD1222. Catalent will prepare the facility to enable round-the-clock manufacturing schedules and supply hundreds of millions of doses of the vaccine candidate from August 2020, and potentially through to March 2022 should the product be approved by regulatory agencies.
The recombinant adenovirus vaccine technology was created by the Jenner Institute at the University of Oxford, and the vaccine candidate is currently in clinical trials.
"Catalent has significant experience in the tech transfer and rapid scale-up of vaccine programs to meet demand," commented Alessandro Maselli, president & COO of Catalent. He added, “Our manufacturing site in Anagni, Italy has served for many years as a primary launch facility for new medicines, and the plant’s skilled team will take great pride in preparing to manufacture this vaccine candidate for COVID-19 and ensuring that the product will be able to reach patients as quickly as possible if approved.”
Catalent’s 28,000 square-meter (305,000 square-foot) facility in Anagni has a demonstrated track record in technical transfers and successful commercial product launches. It offers extensive capabilities in aseptic liquid filling for biologics and sterile products across multiple vial sizes. The site also provides comprehensive primary and secondary packaging solutions, including serialization, to support product launches for oral solids, sterile, and biologics products. In addition to the Anagni facility, Catalent’s Biologics network includes sterile drug product manufacturing and packaging facilities in Brussels, Belgium and Bloomington, Indiana, and additional facilities in Europe and the United States for manufacturing proteins, viral vectors for gene therapies and cell therapies, and biologics analytical services.