SOMERSET, N.J. – April 13 2021— Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced that it has completed the expansion of two new 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 new mammalian cell culture suites at the Madison site in January 2019. 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 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.”
Opened in April 2013, Catalent Biologics’ Madison facility provides development, manufacturing, and analytical services for new 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-liter scale, and also provides non-CGMP production up to 250-liter scale.
The addition of the two new manufacturing suites adds to an existing 2x2,000-liter suite, a 1,000-liter suite and a 500-liter suite. Catalent Biologics’ drug substance manufacturing network also includes a facility in Bloomington, Indiana, which houses two 2,500-liter stainless-steel bioreactors, and a 1,000-liter single-use bioreactor for CGMP production, as well as comprehensive drug product fill/finish and packaging capabilities.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special offers
from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!