Catalent to further grow its Italian biologics facility

Catalent, a delivery technology provider, will be starting the first phase of a $100 million expansion program at its facility in Anagni, Italy, in order to add biologics drug substance manufacturing capabilities. This move, says the contract development and manufacturing organization (CDMO), is intended to support the growing European market demand for biologics manufacture and supply, and is expected to be operational by April 2023. As a result, it will increase the site’s staff by up to 100 employees.

The initial expansion phase features the installation of two 2,000-liter single-use bioreactors within new 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 an additional six 2,000-liter single-use bioreactors. Later phases of the planned expansion contemplate the provision of 16,000 liters of total flexible manufacturing capacity, supporting a 2,000-liter to 8,000-liter batch production scale.

Catalent's Anagni site is a biologics and oral dose manufacturing facility that focuses on late-stage and commercial product launches.