The CAGT Vector Production Facility contains 7 ISO 7 clean rooms with
access to an additional three suites to extend capacity when needed.
Each suite operates at 60 air changes per hour with single pass air.
The facility is of pharmaceutical clean room design with a clean corridor at
positive pressure with respect to the manufacturing suites, which are at positive
pressure with respect to the dirty corridor.
All suites are equipped with mobile cabinetry with stainless steel worksurfaces,
one or more 6” biological safety cabinets, tabletop centrifuge, multiple HEPA-filtered incubators, inverted microscope, refrigerator and PC equipped with barcode scanner. Specialized cell culture, and vector purification equipment is available.
Equipment and critical facility parameters are continuously monitored via a wireless alarm system, with on and offsite surveillance and data collection. Environmental and production monitoring are performed by the Quality Control Laboratory. Materials and equipment used during manufacturing are tracked using a barcoding system which maintains expiration and calibration records. Quality Assurance provides oversight of all manufacturing and facility operations.
The facility was a National Gene Vector Laboratory (NGVL) for the production of adenoviral vectors until the discontinuation of the NGVL system. It has manufactured more than 35 clinical grade adenoviral vectors. In addition the VPF has extensive experience in the manufacture of clinical retroviral vectors and has prepared Herpes vectors, plasmids, monoclonal antibodies and clinical grade Epstein Barr virus under contract.
The VPF also collaborates with the CAGT Vector Development Laboratory in vector design and the preparation of research grade vectors.
1102 Bates Street, Suite 1670
Houston, Texas 77030
Center for Cell & Gene Therapy - cGMP Facilities