SOMERSET, N.J. — Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it will commence the first phase of a planned $100 million expansion program at its facility in Anagni, Italy, 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-liter single-use bioreactors within new, 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-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, enabling 2,000-liter to 8,000-liter batch production scale.
Catalent’s Anagni site is a world-class 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 its existing capabilities, which 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 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.”
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, offering one of the largest pre-filled syringe filling capacities in the region for late-stage and commercial programs. In the U.S., 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 extensive 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 or 4,000-liters.
About Catalent Biologics
Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with over 600 mAbs and over 80 proteins, produced 13 biopharmaceutical drugs using GPEx® cell line development technology, and manufactured more than 45 commercially approved products. Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. For more information, visit biologics.catalent.com