CDMO Catalent has completed an $85 million expansion at its Madison drug substance facility and has started work on customer programs.

The contract development manufacturing organization (CDMO) Catalent has added two mammalian cell culture suites at its Madison facility, meaning the site has five suites in total and has more than doubled its overall capacity.

The two additional suites each boast a 2 x 2,000 L single-use bioreactor system that can process batches of 2,000 L or 4,000 L for both clinical and commercial manufacturing. The expansion adds to the firms existing 2 x 2,000 L suite, a 1,000 L suite, and a 500 L suite at the site.

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To meet customer demands and service the site’s scale-up, Catalent has hired new members of staff.

“There’s about 450 employees at the site today,” Stacey Treichler, group product manager at Catalent told BioProcess Insider. “They have hired about 150 new [employees] at the site in the past 12 months, and they plan to hire another 150 over the next year.”

According to the CDMO, the first engineering batch using one of the new suites began in March 2021 and the first current Good Manufacturing Practice (cGMP) batch is expected to be produced during May. The second additional suite will also begin engineering its first batch in May, prior to its first CGMP batch expected to commence in mid-July.

Pre-pandemic plans

Catalent first announced its plans to invest at its Madison site in January 2019 with the board ploughing $100 million into the plant to add a fourth and fifth biomanufacturing train, boosting commerical capacity.

According to Treichler, while the “pandemic brought additional challenges” Catalent has “been able to stay on the timeline that they originally hoped for.” She continued: “COVID might have been driving some hiring and demand at the site to leverage our existing capabilities and expertise in mRNA, [but] that is completely separate from the site expansion […] because the expansion is going to serve protein-based products.”

Bernie Clark, VP of global marketing and strategy at Catalent echoed Treichler’s statement and told us that while Catalent is “involved in several COVID related programmes, the ones that are widely publicized are the larger vaccine programmes that have received emergency approval from various regulators, those tend to be within our drug product fill/finish sites.”

He added: “Within Madison, we do have some clinical programmes that are COVID related, but I wouldn’t say they’re tying up large amounts of capacity within our facility.”

This month, Catalent added a high-speed vial filling line for Moderna at its Bloomington, Indiana facility to free up capacity for its other, non-COVID-related customers and meet COVID-19 contractual demands. At the same facility in March this year, Catalent dedicated a line to Johnson & Johnson for its single-shot COVID-19 jab.