Regency Electric Project Gallery

St.Jude CGMP

  • St.Jude CGMP

The GMP center is a biocontainment facility in which up to 12 clinical trial production projects can be run simultaneously. This supports research applications ranging from avian flu, HIV, gene therapy, and monoclonal antibodies. The new facility is dedicated to manufacturing highly specialized medicines, vaccines, drugs, proteins, gene-based molecules and other biological products under the FDA's strict guidelines for Good Manufacturing Practices. Of the 12 GMP production suites, two are BSL3 laboratories that can accommodate work with microorganisms that require strict containment procedures. Two floors of the facility contain production space and administrative space that includes offices, document storage areas, conference rooms, training rooms, and space for materials handling and waste management. One floor is devoted entirely to mechanical/electric systems, including all of the air handlers, pure steam generators, clean steam generators, and VAV control boxes. Each of the GMP production rooms is protected by airlock access and includes fixed biosafety hoods. Since there are no other fixed equipment in the production rooms, equipment is moved in and out based upon the requirements of that particular production. A unique utility panel was developed to reduce the number of penetrations in production room walls for the mechanical and electrical systems, designed so that there was only one large hole in the wall that needed to be sealed within the production rooms. Production rooms are ISO Class 7, using one-pass air and all rooms receive more than 50 air exchanges per hour.