Catalent has announced that it will begin the first phase of a planned $100-million expansion at its facility in Anagni, Italy to add biologics drug-substance manufacturing.

The initial phase of the expansion will see 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 a further six 2,000-liter 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. Later phases of the planned expansion contemplate the provision of 16,000 liters of total flexible manufacturing capacity to enable 2,000-liter to 8,000-liter batch production scale.

Catalent’s Anagni site now provides aseptic filling, secondary packaging, and oral dose manufacturing for late-stage and commercial product launches. Since Catalent acquired the facility in January 2020, it has become a European hub for COVID-19 vaccine manufacturing. The addition of biologic drug-substance manufacturing will complement its existing capabilities, which include aseptic vial filling and secondary packaging of biologic, sterile, and vaccine products.

Catalent Biologics’ 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, for largest pre-filled syringe filling for late-stage and commercial programs. In the US, Catalent Biologics’ network includes mammalian drug-substance development and manufacturing for clinical and commercial programs at its Madison, Wisconsin, and Bloomington, Indiana, facilities, which house single-use and stainless-steel capacity, respectively. The Bloomington facility also houses fill-finish capabilities. The Madison site recently added its fourth and fifth manufacturing suites, each with a 2 × 2,000-liter single-use bioreactor system capable of processing batches of 2,000 liters or 4,000-liters.

Source: Catalent