Cell Processing Facility
Contact: James Adams
Contact phone: (206) 667-6131
Contact fax: (206) 667-1096
Contact e-mail: CellProcessingFacility@fredhutch.org
We provide support for reproducible production of human hematopoietic or immune-competent cells under stringent quality control and safety conditions required for therapeutic studies.
Cell production services include enrichment or depletion of specific cell subsets, provision of normal donor feeder cells, maintenance of transformed feeder cell lines, cloning, ex-vivo antigen priming, cytokine and antibody-based activation, genetic modification, expansion, cryopreservation and/or preparation for infusion of many different types of extensively manipulated cell populations.
All manufacturing activities are conducted using approved written procedures performed by trained, qualified personnel in accordance with cGMP and current Good Tissue Practices (cGTP) guidelines. Quality assurance oversight and review is provided to assure regulatory compliance and safety of therapeutic products.
To initiate service or obtain additional information, contact the facility director (x6131)
The facility was constructed according to specifications set by Code of Federal Regulations Title 21, Sections 210 and 211 to meet current Good Manufacturing Practice (cGMP).
The Cell Processing Facility contains approximately 3,700 square feet of space serviced by an independent HVAC system. The facility consists of four separate suites designed for cell culture, material preparation, and clinical production. The cGMP Cell Processing manufacturing facility at Fred Hutchinson Cancer Research Center contains approximately 3,700 square feet of space serviced by an independent HVAC system. The facility consists of four separate suites designed for cell culture, material preparation, and clinical production.
Manufacturing suites supporting the production of cellular therapeutics are equipped with biological safety cabinets and numerous double stack incubators. Other major equipment includes floor and table top centrifuges, cell washers, sterile connecting devices and large scale cell enrichment devices.
In conjunction with these core equipment capabilities, the facility maintains a separate well equipped quality control laboratory space to provide product characterization and safety testing capabilities, such as automated cell counts, and flow cytometry as required by the FDA for clinical studies.