Somerset, N.J.-based Catalent, which enables biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, has announced a $230 million expansion. The project calls for the addition of three further commercial-scale viral vector manufacturing suites and associated support facilities and services at its gene therapy campus in Harmans.
The 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 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 Current Good Manufacturing Practice (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 multi-story 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 during 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,” said Manja Boerman, 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.