Cell Processing Facility

The CAGT Cell Processing Facility 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 percent recirculated air and is at positive pressure with respect to the external corridor. All 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 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 a Facility Master File with the U.S. Food and Drug Administration and is accredited by the Foundation for the Accreditation of Cellular Therapy.