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Center for Cell and Gene Therapy

Vector Production Facility

Master
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The CAGT Vector Production Facility contains seven 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 work surfaces, 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 has a Facility Master File with the U.S. Food and Drug Administration.

The VPF also collaborates with the CAGT Vector Development Laboratory in vector design and the preparation of research grade vectors.

For additional information contact Dr. Zhuyong Mei.