Catalent undergoes facility expansion, more than doubling its capacity

Catalent, a delivery technology provider, has completed the expansion of two new suites at its biologics drug substance development and manufacturing facility in Madison, WI, and has now started work on customer programs. The expansion has increased the number of manufacturing suites at the site to five, more than doubling its overall cGMP (current good manufacturing practice)-scale capacity.

Each new suite includes a 2x2,000-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, with the first cGMP batch expected to be manufactured in 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,” said Mike Riley, region president, biologics, North America. “Catalent’s continued investment in technology and capacity will enable us to bring our customers’ important and innovative treatments to patients faster.”

Catalent Biologics’ drug substance manufacturing network also features a facility in Bloomington, IN, which contains two 2,500-liter stainless-steel bioreactors, and a 1,000-liter single-use bioreactor for cGMP production, along with drug product fill-finish and packaging capabilities.