SOMERSET, N.J. – October 26, 2021 — Catalent, the global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced a $230 million expansion project to add three further commercial-scale viral vector manufacturing suites and associated support facilities and services at its gene therapy campus in Harmans, Maryland, to meet growing customer demand.
The Harmans campus, located close to Baltimore Washington International Airport (BWI), includes a now fully operational, state-of-the-art U.S. FDA- and EMA-approved facility comprising 10 commercial-scale manufacturing suites. A second facility is under construction following an initial $130 million investment by Catalent in 2020, which will add five new manufacturing suites that are expected to be operational mid-2022. This latest investment will include the construction of three additional multi-room commercial suites, as well as expanding the site’s storage capabilities for just-in-time inventory space, ultra-low temperature freezers, and its water-for-injection infrastructure. When complete at the end of 2022, the campus will house a total of 18 CGMP viral vector manufacturing suites, each designed to accommodate multiple bioreactors up to 2,000-liter scale and enable the execution of commercial manufacturing from cell bank to purified drug substance.
Other facilities, including multistory parking and an onsite cafeteria, are planned for the campus to support the significant anticipated growth in employee numbers. The expansion will see the creation of more than 700 new technical, scientific, and operational employment positions over the next six years.
“Catalent is committed to continuous improvement and growing with our customers’ futures in mind. This necessitates that we consistently incorporate our own learnings and the latest developments in CGMP manufacturing into our new and existing facilities and operations, to help assure quality and de-risk processes,” commented Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. “By applying the expertise we have gained from the last three years of operating our flagship gene therapy commercial facility, we are able to continue to expand our campus with a design layout that is innovative, efficient, and provides ultimate flexibility for our customers.”
The Harmans/BWI campus has a total footprint of approximately 350,000 square feet and is part of Catalent’s Maryland-based network of gene therapy, plasmid DNA and oncolytic virus facilities that offer horizontally integrated solutions to support advanced therapy programs from gene to clinic. The recent addition of process development and CGMP production of plasmid DNA at multiple scales at its Rockville facility, together with its process development and CGMP cleanroom suites for early-phase viral vector programs at Baltimore BioPark, located at the University of Maryland, provide the foundation for Catalent’s commercial gene therapy manufacturing services.
ABOUT CATALENT CELL & GENE THERAPY
Catalent Cell & Gene Therapy is an industry-leading technology, development, and manufacturing partner for advanced therapeutics. Its 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. An experienced and innovative partner, Catalent Cell & Gene Therapy has a global network of dedicated, small- and large-scale clinical and commercial manufacturing facilities, including an FDA-licensed viral vector facility, and fill/finish capabilities located in both the U.S. and Europe.
Catalent is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world.
With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply over 70 billion doses of more than 7,000 products to over 1,000 customers annually.
Catalent’s expert workforce exceeds 17,000, including more than 2,500 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated $4 billion in revenue in its 2021 fiscal year. For more information, visit www.catalent.com.