Catalent will add biologics drug substance production capabilities to its Italian plant, which it says will support demand from the European market.

The $100 million investment will see contract development manufacturing organization (CDMO) Catalent install two 2,000 L single-use bioreactors in newly constructed manufacturing suites at its Anagni, Italy facility it acquired from Bristol Myers Squibb in June 2019.

Additionally, the firm will build infrastructure required to house a further six 2,000 L single-use bioreactors and the first phase of the expansion is anticipated to be operational for customer use in April 2023.

Image: iStock/marekuliasz

“We look at this market very closely and it has been apparent to us there has been a lack of supply and capacity available in the European region,” Bernie Clark, VP of global marketing and strategy at Catalent told BioProcess Insider.

“Our major plant in Anagni would be a perfect fit for us to be adding to our drug substance network. We have many customers who are manufacturing in multiple regions and like to have the option of both North America and Europe, so they will have the ability to continuously scale up in both locations and easily do a tech transfer to our Anagni facility in the future.”

Catalent also has drug substance capacity in Bloomington, Indiana and Madison, Wisconsin.

The firm also outlined the later phases of the expansion, which includes the potential of adding 16,000 L of flexible production capacity, enabling 2,000 L to 8,000 L batch manufacturing scale.

Clark told us “adding additional bioreactors will be easy and quick for us to do.”

While the Anagni facility became a European hub for COVID-19 vaccine manufacturing in January 2020 with Astra Zeneca and Johnson & Johnson having dedicated filling lines at the site, Clark confirmed Catalent is not adding capacity “necessarily for the COVID demand, but for the overall demand and growth that we see in biologics.”

By adding drug substance manufacturing capabilities, Clark said the facility essentially “connects drug substance manufacturing along with drug product production and packaging all on one site.”

Through bringing these service offerings together, “we reduce the overall complexities and timelines that are common when working across various sites, but also with different partners.”

The expansion will increase the company’s headcount at the site by 100. The CDMO has already begun reaching out to local partners, industry partners, the Italian government, and different universities.

“We’re going to be recruiting for a number of different types of roles, from scientific to engineering roles and a number of supporting roles that you will need to add over the coming months and years,” said Clark.