When complete, the campus will house a total of 18 CGMP viral vector manufacturing suites, each designed to accommodate multiple bioreactors up to 2000 L
Catalent has announced a $230m 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 campus, located close to Baltimore Washington International Airport (BWI), includes an FDA- and EMA-approved facility comprising 10 commercial-scale manufacturing suites. A second facility is under construction following an initial $130m investment by the company in 2020, which will add five manufacturing suites, which are expected to be operational mid-2022.
The investment will also include the construction of three additional multi-room commercial suites, as well as expanding the site’s storage capabilities for inventory space, 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 2000 L 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 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,” said Manja Boerman, PhD, 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 campus has a total footprint of approximately 350,000 soft and is part of the company’s Maryland-based network of gene therapy, plasmid DNA and oncolytic virus facilities.