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World-class Facilities

At Catalent, our track record speaks for itself. We work with more than 20 premier gene therapy innovators and have experience with more than 60 gene therapy programs, creating the ideal environment in which life-changing ideas can flourish. This comes from constant evolution and innovation. It comes from providing the highest quality solutions based on cutting-edge science, logical thinking, years of experience, and the passion of people invested in the field.

To meet these high standards for our customers, we have built and developed world-class development and manufacturing centers that are equipped with the talent, technology, and high quality necessary for successful production. Our facilities are located near the scientific centers of major universities and biotech-rich areas in the state of Maryland. We have several process development and clinical manufacturing (Phase 1 and 2) facilities, including our Baltimore Development Center at the University of Maryland Biopark and the Montgomery Center along the I-270 Technology Corridor of Gaithersburg and Rockville. Our FDA licensed Phase 3 through Commercial Production Campus is located a few miles from the Baltimore Washington International (BWI) airport in Harmans with expansions planned to provide additional commercial suites.

University of Maryland Biopark Development Center

Process and Analytical Development Capabilities

  • ~25,000 sq. ft. of process and analytical development space
  • Client-dedicated labs for longer-term process development
  • Characterization programs
  • Full-scale production capabilities, tox production on expedited timelines

CGMP Capabilities for Clinical Manufacturing

  • 10 CGMP suites with more than 23,000 sq. ft. of manufacturing space
  • US/EU compliant facility and quality systems
  • Multiple scales
    • 200L, 400L, or 800L production capabilities for suspension
    • Up to 2xiCELLis® 500 for adherent cultures
    • Up to 24 HYPERStack® 26/CS10 for adherent cultures
  • QC testing on site
  • Just-in-time warehousing: protocols for transportation, temperate controlled

BWI Commercial Campus

  • 151,000 sq. ft. of commercial space
  • 8-10 CGMP manufacturing suites including fill/finish
  • Central services labs
  • Testing labs
  • Central warehouse and supply chain hub
  • Close to the BioPark development center, contributing to operational efficiencies
  • Centrally located near a major airport
  • Close to universities and government agencies and the BioPark center
  • Closer to Washington DC’s 270 biopharma corridor for advanced recruiting

Montgomery Facilities

  • Two state-of-the-art development facilities in Gaithersburg and Rockville, Maryland
  • Over 100,000 sq. ft. of CGMP manufacturing/testing, analytical and formulation development, and quality assurance between both facilities
iCELLis is a trademark of Pall Corporation.
HYPERstack is a trademark of Corning Incorporated.