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Core B: Pharmaceutical Production

Core B: Pharmaceutical Production
核心B：药品生产
批准号：
8742468
负责人：
JOHN M PAGEL
金额：
$32.23万
依托单位：
FRED HUTCHINSON CANCER RESEARCH CENTER
依托单位国家：
美国
项目类别：
财政年份：
2000
资助国家：
美国
项目状态：
已结题
起止时间：
2000-03-31 至 2019-08-31
来源：
https://reporter.nih.gov/project-details/8742468
关键词：
AddressAllograftingAlpha ParticlesAntibodiesAstatineBiodistributionBismuthCanis familiarisCellsChimerismClinicalClinical ResearchClinical TrialsCyclotronsDiscipline of Nuclear MedicineDiseaseEvaluationFred Hutchinson Cancer Research CenterFundingHematopoieticHumanImageInvestigational New Drug ApplicationLabelLaboratoriesMalignant - descriptorMetalsMonoclonal AntibodiesPTPRC genePatientsPharmaceutical PreparationsPharmacologic SubstancePhasePositronPreparationProductionProgram Research Project GrantsRadiochemistryRadioimmunotherapyRadioisotopesRadiolabeledReactionReagentRegimenResearchResource SharingResourcesStem cellsTreatment ProtocolsUnited States Food and Drug AdministrationUniversitiesWashingtonantibody conjugatedosimetryhematopoietic cell transplantationirradiationmultidisciplinarynovelpre-clinicalpreclinical studypublic health relevanceradiotracer

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ABSTRACT - CORE B Core B is responsible for the production of clinical grade anti-human CD45 BC8 antibody (Projects 2 and 3). The antibody will be conjugated with a reagent (B10-NCS) for radiolabeling with astatine-211. All antibodies and clinical grade reagents will be produced, purified and vialed in the Biologics Production Facility of the Fred Hutchinson Cancer Research Center. Pre-clinical and clinical radiolabeling reactions will be conducted in appropriate radiochemistry laboratories at the University of Washington. Clinical grade BC8-B10 will be produced under current good manufacturing practice (cGMP) conditions and a Drug Master File will be developed and submitted to the Food and Drug Administration. In addition, Core B will be responsible for the establishment of an IND to support conduct of Phase I human clinical trials. Core B will also be responsible for radiolabeling anti-canine ICOS with 123I and 211At which are required for biodistribution and therapy studies respectively for Project 1. The anti-ICOS antibody itself will be produced using resources supplied to Project 1.
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