Catalent has completed the expansion of two new suites at its biologics drug substance development and manufacturing facility in Madison, WI, and began work on customer programs. The expansion more than doubled overall CGMP-scale capacity, increasing the number of manufacturing suites at the site to five.
 
Catalent announced plans to add two new mammalian cell culture suites at the Madison site in January 2019. Each new suite includes a 2×2,000-liter single-use bioreactor system capable of processing batches of 2,000 liters or 4,000 liters for CGMP clinical and commercial manufacturing. The first engineering batch in the new suite began in March 2021, with the first CGMP batch expected to be manufactured during May. The second new 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,” commented 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.”
 
Catalent Biologics’ Madison facility opened in April 2013 and provides development, manufacturing, and analytical services for new biologics and biosimilars and is home to the company’s GPEx cell line technology, which is used to create high-yielding mammalian cell lines.