WATCH THIS PAGE

Subscribe to be notified of changes or updates to this page.

12 + 8 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Clinical Vector Core Facility

AddtoAny
Share:

Let’s Work Together

Contact our Clinical Vector Core experts for a consultation to learn how we can help bring your cell and gene therapy projects from the laboratory to the patient's bedside. Ready to get started? Complete the Vector Request Form for highly customized viral vector manufacturing services compliant with current Good Manufacturing Practices.
Request our services

The Clinical Vector Core provides dedicated facilities for adeno-associated virus and lentiviral clinical and non-clinical vector manufacturing in support of clinical trials. Facility systems, manufacturing equipment, and aseptic fill and finish operations are validated and compliant with current Good Manufacturing Practices (cGMP).

Inside the CVC’s State-of-Art Manufacturing Facility

Elevator lobby in the Raymond G. Perelman Center for Molecular Therapeutics

Supply processing room

Clean corridor

Production suite

Fill and finish suite

State-of-the-art fully redundant infrastructure support systems

Additional view, fully redundant infrastructure support systems

Clinical Vector Core Facility

  • Spans 13,000 square feet
  • Includes 9,000 square feet of cGMP cleanrooms
  • Four vector production suites
  • Fill and finish suite
  • Cell expansion suite
  • Quality control
  • Warehouse
  • Waste station
  • Suite for pharm/tox products for Good Laboratory Practice studies

Manufacturing

  • Compliant with FDA and EU regulatory requirements
  • Cleanrooms are qualified to EU standards
  • Grade B production rooms with Grade A biosafety cabinets
  • Equipped with continuous particle monitoring
  • Environmental monitoring program for air, surfaces, and personnel monitoring
  • Whole suite vaporized hydrogen peroxide decontamination and change-over
  • Aseptic technologies Crystal M1 filling station for product fill in fill room
  • Qualified platform processes and validated equipment
  • 100% redundancy on facility support systems and emergency power

Quality Control

  • Validated equipment and qualified assays
  • Raw material identity and release testing
  • Vector identity, safety, and purity testing for crude harvest, bulk, and final product
  • Facility environmental monitoring
  • Media fill qualification
  • Gowning qualification
  • Device compatibility testing support
  • Freeze/thaw and short-term stability support
  • Product long-term stability testing