The initial phase of the expansion will see the installation of two 2,000 L single-use bioreactors within purpose-built manufacturing suites
Catalent, a provider of development and manufacturing solutions for drugs and biologics, has announced it will commence the first phase of a planned $100m expansion program at its Anagni, Italy facility to add biologics drug substance manufacturing capabilities, supporting the growing European market demand for biologics manufacture and supply.
The initial phase of the expansion will see the installation of two 2,000 L single-use bioreactors within purpose-built manufacturing suites and associated investments to support early-phase clinical development as well as late-stage and commercial tech transfers. It will also include the creation of the infrastructure required for a further six 2,000 L single-use bioreactors. The initial expansion is expected to be commissioned and operational for customer projects in April 2023 and will increase the site’s workforce by up to 100 employees.
The Anagni site specialises in late-stage and commercial product launches. Since the company acquired the facility, in January 2020, it has become a European hub for COVID-19 vaccine manufacturing, Catalent says. The addition of drug substance manufacturing will complement its existing capabilities, which include aseptic vial filling and secondary packaging of biologic, sterile, and vaccine products.
“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," said 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.”
The 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, offering pre-filled syringe filling capacities for late-stage and commercial programs.