Catalent Biologics will provide vial filling and packaging capacity to AstraZeneca from its 305,000 sq.-ft. 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 pending approval 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 Phase II/III clinical trials.
"Catalent has significant experience in the tech transfer and rapid scale-up of vaccine programs to meet demand," commented Alessandro Maselli, President & Chief Operating Officer 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.”
The Anagni facility provides aseptic liquid filling for biologics and sterile products across multiple vial sizes. The site also provides primary and secondary packaging, including serialization, to support product launches for oral solids, sterile, and biologics.