Catalent has completed the expansion of two suites at its biologics drug substance development and manufacturing facility in Madison, Wisconsin, and has now commenced work on customer programs. The expansion has increased the number of manufacturing suites at the site to five, more than doubling its overall CGMP-scale capacity.
Catalent first announced the investment to add two mammalian cell culture suites at the Madison site in January 2019. Each suite includes a 2x2,000 L single-use bioreactor system capable of processing batches of 2,000 L or 4,000 L for CGMP clinical and commercial manufacturing. The first engineering batch in the suite began in March 2021, with the first CGMP batch expected to be manufactured during May. The second suite is being prepared to begin its first engineering batch in May, ahead of its first CGMP batch in mid-July.
“This new capacity will allow us to meet growing clinical and commercial demand from both existing and new customers,” said Mike Riley, Region President, Biologics, North America. He added, “Catalent’s continued investment in technology and capacity will enable us to bring our customers’ important and innovative treatments to patients faster.”
Opened in April 2013, Catalent Biologics’ Madison facility provides development, manufacturing, and analytical services for biological entities and biosimilars and is the home of the company’s proprietary GPEx cell line technology, which is used to create high-yielding mammalian cell lines. The facility was designed for flexible clinical and commercial CGMP production, from 100 to 4,000 L scale, and also provides non-CGMP production up to 250-liter scale. The addition of the two manufacturing suites adds to an existing 2x2,000 L suite, a 1,000 L suite and a 500 L suite.
The company’s drug substance manufacturing network also includes a facility in Bloomington, Indiana, which houses two 2,500 L stainless-steel bioreactors, and a 1,000 L single-use bioreactor for CGMP production, and drug product fill/finish and packaging capabilities.
