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 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
- ~120,000 sq. ft.
- Process and analytical development
- Phase 1/2 clinical manufacturing
- 8 CGMP suites
- Traditional AAV programs, lentivirus and baculovirus
Viral Vector Commercial Campus
- ~345,000 sq. ft.
- EMA and FDA approved
- PPQ/Phase 3 and commercial manufacturing
- 18 CGMP suites across 2 buildings
- Quality control and central services labs
- Fill/finish capabilities
Plasmid DNA Facilities
- ~49,000 sq. ft.
- Process and analytical development
- Clinical and commercial-scale manufacturing
- 5 CGMP suites across 2 buildings