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THERAPEUTIC MANUFACTURING

THERAPEUTIC MANUFACTURING
治疗性制造
批准号:
7944785
负责人:
LELAND H HARTWELL
金额:
$55.36万
依托单位国家:
美国
项目类别:
财政年份:
2009
资助国家:
美国
项目状态:
已结题
起止时间:
2009-03-10 至 2013-12-31
关键词:
AddressAntibodiesAntigensAutoimmune DiseasesBiochemicalBiologicalBiological AssayBiological ProductsBiologyBiotinBreast MelanomaCalibrationCancer Center Support GrantCell CountCell Culture SystemCell LineCell MaintenanceCell TherapyCell physiologyCellsChemicalsClassificationClinicalClinical ResearchCloningCommunicable DiseasesComplexCryopreservationCustomCyclic GMPDNADevelopmentDisease ProgressionDocumentationDrug FormulationsEducational process of instructingEndotoxinsEnsureEnvironmental MonitoringEnzyme-Linked Immunosorbent AssayEquipmentEquipment and supply inventoriesFlow CytometryFluorochromeFred Hutchinson Cancer Research CenterGenesGeneticGrantGuidelinesHematologic NeoplasmsHumanHuman ResourcesImmunotherapyInfusion proceduresInstitutionInvestigationInvestigational New Drug ApplicationLaboratoriesLaboratory ResearchLeadershipMaintenanceMalignant NeoplasmsMalignant neoplasm of prostateManufactured MaterialsMethodologyMethodsModificationMolecularMonitorMycoplasmaOsmolalitiesOutputOvaryPatientsPeptidesPharmaceutical PreparationsPhasePhenotypePilot ProjectsPopulationPost-Translational Protein ProcessingPreparationProceduresProcessProductionProductivityProkaryotic CellsProteinsQualifyingQuality ControlReagentRecordsRegulationRequest for ApplicationsResearchResearch ActivityResearch InfrastructureResearch PersonnelResolutionResourcesRoleRunningSafetySerum-Free Culture MediaServicesSodium Dodecyl Sulfate-PAGESourceSpecific qualifier valueStagingStandard PreparationsSterilityStreamSystemTechnical ExpertiseTestingTherapeuticTimeTrainingTranslational ResearchTransplantationUmbilical Cord BloodUniversitiesUpdateValidationWashingtonWorkanalytical methodbasecancer therapycell bankcell typeclinical materialcytokineinnovationlarge scale productionmanufacturing facilitymeetingsmicrobialnovelpre-clinicalpre-clinical researchprocess optimizationprogramsquality assuranceresearch clinical testingresponsescale upvalidation studies

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中文摘要
翻译
弗雷德哈钦森癌症研究中心(FHCRC)和华盛顿大学(UW)提供广泛的
英文摘要
The Fred Hutchinson Cancer Research Center (FHCRC) and University of Washington (UW) offer a broad range of facilities and qualified trained personnel to support the development and manufacturing of novel biological molecules and innovative cell-based therapies for Phase I/I I clinical testing. These facilities are an integral part of the two institution's world-renowned translational research efforts. In support of these efforts, FHCRC and UW have consolidated their three Good Manufacturing Practice (GMP) facilities into one jointly co-administered and operated Therapeutic Manufacturing Unit. Combining the FHCRC Biologies Production and Cell Processing Facilities (previously supported by this grant) with the UWs Gene and Cell Therapy Core Laboratory has allowed these two institutions to further build on their leadership roles in the application of immunotherapy for the treatment of hematological malignancies, and to extend this innovative work to other clinical settings such as autoimmune disorders, melanoma, breast, ovary, and prostate cancer. These facilities permit the reproducible production of large-scale quantities of biological reagents and therapeutic cells under the strict quality control and safety conditions required by the FDA for human studies. Successful development of such materials will have obvious significance for many patients. Further, progress in pursuit of these aims will have relevance for other clinical situations, teaching us valuable lessons about the molecular basis for disease progression, induction of transplant tolerance, response to infectious diseases, and especially about immunotherapy approaches for the treatment of cancer. This application requests continued support for a resource which fulfills an essential role for research within the Fred Hutchinson/University of Washington Cancer Consortium.
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