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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. For gene therapies, we have several process development and clinical manufacturing (Phase 1 and 2) facilities and a state-of-the-art Phase 3 through Commercial Production Campus, including our EMA and FDA approved facility. Our plasmid DNA facilities offer process and analytical development, and up to CGMP-grade production capabilities.

Our gene therapy facilities are located near the scientific centers of major universities and biotech-rich areas in the state of Maryland, including Baltimore at the University of Maryland BioPark, along the I-270 Technology Corridor, and near the Baltimore Washington International Airport (BWI). Our plasmid DNA facilities are located in Maryland and Gosselies, Belgium, ideally located near our gene therapy locations and within our European Center of Excellence.

Gene Therapy Facilities

Viral Vector Clinical Centers

Baltimore BioPark

  • ~120,000 sq. ft.
  • Process and analytical development
  • Phase 1/2 clinical manufacturing
  • 8 CGMP suites
  • Traditional AAV programs, lentivirus and baculovirus

Gaithersburg

  • ~54,000 sq. ft.
  • Process development
  • Phase 1/2 clinical manufacturing
  • 3 CGMP suites
  • Oncolytic virus, live virus, and vaccines

 

Viral Vector Commercial Campus

Harmans/BWI

  • ~345,000 sq. ft.
  • EMA and FDA approved
  • PPQ/Phase 3 and commerical manufacturing
  • 15 CGMP suites across 2 buildings
  • Quality control and central services labs
  • Fill/finish capabilities

 

Plasmid DNA Facilities

Rockville

  • ~50,000 sq. ft.
  • Process and analytical development
  • Clinical and commercial-scale manufacturing
  • Up to 4 CGMP suites

Gosselies

  • ~49,000 sq. ft.
  • Process and analytical development
  • Clinical and commercial-scale manufacturing
  • 5 CGMP suites across 2 buildings

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