The CAGT Cell Processing Facility (CPF) contains 12 ISO 7 clean
rooms with access to an additional three suites to extend capacity when
needed. Each suite operates at 20-40 air changes per hour with 50% recirculated
air and is at positive pressure with respect to the external corridor.
All 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 separation, counting, washing and cryopreservation equipment is available to staff. 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 CPF has manufactured thousands of cell therapy products and intermediates including the following:
The CPF has a Facility Master File with the US Food and Drug Administration and
is accredited by the Foundation for the Accreditation of Cellular Therapy.
1102 Bates Street, Suite 1670
Houston, Texas 77030
Center for Cell & Gene Therapy - cGMP Facilities