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Catalent’s new mammalian cell culture suites in Madison, Wis. use single-use bioreactor systems for CGMP clinical and commercial manufacturing.
Catalent announced on April 13, 2021 that it has completed its expansion of two new mammalian cell culture suites at its biologics drug substance development and manufacturing facility in Madison, Wis.
Each suite feature a 2x2000-L single-use bioreactor system aimed at processing batches of 2000 liters or 4000 L for current good manufacturing practice (CGMP) clinical and commercial manufacturing, Catalent said in a company press release. The first engineering batch in one new suite started in March 2021, with the first CGMP batch expected to be manufactured during May 2021. The second suite is set to begin its first engineering batch in May 2021 and its first CGMP batch in July 2021. The new manufacturing suites add to an existing 2×2,000-L suite, a 1000-L suite, and a 500-L suite.
“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, Catalent, in the press release. “Catalent’s continued investment in technology and capacity will enable us to bring our customers’ important and innovative treatments to patients faster.”