The initial phase, due to be commissioned  in April 2023,will see the installation of two 2,000-liter single-use bioreactors within new, purpose-built manufacturing suites, along with associated investments to support early-phase clinical development as well as late-stage and commercial tech transfers. As many as 100 employees will be added.

Catalent will also create the infrastructure required for a further six 2,000-liter single-use bioreactors. In later phases, the company said it may add 16,000 liters of total flexible manufacturing capacity, enabling 2,000-liter to 8,000-liter batch production scale.

The Italian site currently is a major hub for Covid-19 vaccine production. Anagni manufactures doses for both the Johnson & Johnson and AstraZeneca vaccines. In March, Catalent said it planned to scale up a second high-speed filling line at the site to boost capacity for J&J's single-dose shot. This capability is expected to be ready by the 2021 fourth quarter.

Adding drug substance manufacturing will complement the site’s existing capabilities, which the CDMO said include extensive 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 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,” said Mario Gargiulio, the CDMO’s regional president Biologics Europe.

The US company’s European network includes a clinical formulation and drug product fill-finish center of excellence in Limoges, France, which is currently being expanded, as well as a site in Brussels, Belgium, which Catalent said offers one of the largest pre-filled syringe filling capacities in the region for late-stage and commercial programs.

Author: Dede Williams, Freelance Journalist