The Maryland campus includes a now fully operational FDA- and EMA-approved facility comprising 10 commercial-scale manufacturing suites. Another facility is being realized as part of an initial $130 million investment kicked off in 2020, which will add five new manufacturing suites expected to be operational mid-2022. Altogether, the expansion will cost $360 million and create 700 new technical, scientific and operational employment positions over the next six years.

In addition to the three new multi-room commercial suites, as an additional part of the ongoing investment, the CDMO is expanding the site’s storage capabilities for just-in-time inventory space, ultra-low temperature freezers and its water-for-injection infrastructure.

Catalent’s Harmans/BWI campus near Baltimore-Washington airport is part of its 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.

When the last additions are in service at the end of 2022, the campus will house 18 CGMP viral vector manufacturing suites. Each is 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.

The recent addition of process development and CGMP production of plasmid DNA at multiple scales at Catalent’s Rockville, Maryland facility, together with its process development and CGMP cleanroom suites for early-phase viral vector programs at Baltimore BioPark at the University of Maryland, provide the foundation for the CDMO’s commercial gene therapy manufacturing services.

Author: Dede Williams, Freelance Journalist