Catalent is investing $230 million in an 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, MD, to meet growing customer demand.
 
The Harmans campus 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 storage capabilities for just-in-time inventory space, ultra-low temperature freezers, and its water-for-injection infrastructure. When complete 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 commercial manufacturing from cell bank to purified drug substance.
 
The expansion will create more than 700 new technical, scientific, and operational 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 sq.-ft. and is part of Catalent’s Maryland-based network of gene therapy, plasmid DNA and oncolytic virus facilities that offer integrated services to support advanced therapy programs from gene to clinic.