Catalent will begin the first phase of a planned $100 million expansion at its facility in Anagni, Italy, to add biologics drug substance manufacturing capabilities to support the growing European market demand for biologics manufacture and supply.

The initial phase of the expansion will include the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites and associated investments to support early-phase clinical development and late-stage and commercial tech transfers. It will also include the infrastructure required for a further six 2,000-liter single-use bioreactors. The initial expansion is expected to be commissioned and operational in April 2023 and will increase the site’s workforce by as many as 100 employees. Later phases of the planned expansion may include 16,000 liters of total flexible manufacturing capacity, enabling 2,000-liter to 8,000-liter batch production scale.

Catalent’s Anagni site is a biologics and oral dose manufacturing facility that specializes in late-stage and commercial product launches. Since Catalent acquired the facility in January 2020, it has become a major European hub for COVID-19 vaccine manufacturing. The addition of drug substance manufacturing will complement capabilities, which include expertise in aseptic vial filling and secondary packaging of biologic, sterile, and vaccine products, while providing new integrated drug substance and drug product capabilities.

“Catalent is committed to supporting customers from small and virtual biotechs to large biopharma companies that require the right capabilities, scale of capacity, and integrated solutions to meet their needs for new biologic therapies and vaccines," commented Mario Gargiulo, Catalent’s Region President, Biologics, Europe. "Catalent was an early adopter of single-use technology because of its flexibility, and we continue to invest in technology that enables adaptable, scalable solutions for the fast-growing segment of biologics addressing mid-sized and orphan patient populations.”