Catalent Biologics Completes Madison Facility Expansion to Double Clinical & Commercial Drug Substance Capacity

Catalent recently announced it has completed the expansion of two new suites at its biologics drug substance development and manufacturing facility in Madison, WI, 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 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. “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 2×2,000-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.

Catalent Biologics is a global leader in development, manufacturing and analytical services for new biological entities, cell and gene therapies, biosimilars, sterile injectables, and antibody-drug conjugates. With over 20 years of proven expertise, Catalent Biologics has worked with 600+ mAbs and 80+ proteins, produced 13 biopharmaceutical drugs using GPEx cell line development technology, and manufactured 35+ commercially approved products. Catalent Cell & Gene Therapy, a unit of Catalent Biologics, is an industry-leading technology, development and manufacturing partner for advanced therapeutics. Its unique and comprehensive cell therapy portfolio includes a wide range of expertise across a variety of cell types including CAR-T, TCR, TILs, NKs, iPSCs, and MSCs. With deep expertise in viral vector development, scale-up and manufacturing for gene therapies, Catalent is a full-service partner for plasmid DNA, adeno-associated viral (AAV), lentiviral and other viral vectors, oncolytic viruses, and live virus vaccines. For more information, visit biologics.catalent.com

Catalent is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable global clinical and commercial product supply. Catalent employs over 15,000 people, including over 2,400 scientists and technicians, at more than 45 facilities, and in fiscal year 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, New Jersey. For more information, visit www.catalent.com