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Preclinical Therapeutics Core

Preclinical Therapeutics Core
临床前治疗核心
批准号:
10449309
负责人:
Michael David Levin
金额:
$23.25万
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-07-08 至 2024-06-30
关键词:
AgreementAnalytical ChemistryAnimal ExperimentsAnimal ModelAnimal TestingAnimalsAntibodiesAntibody FormationAntibody-drug conjugatesBiological AssayBiologyBlood VesselsCaliforniaCalorimetryCaveolaeChelating AgentsChemistryClinicalClinical TrialsCollaborationsConsultationsContractsCyclic GMPDevelopmentDextransDisease modelDoctor of PhilosophyEnsureEnzymatic BiochemistryEquipmentExclusionFluorescenceFluorescence PolarizationHybridomasHydrophobic InteractionsImageImmunoconjugatesIndustrializationInstitutionIon-Exchange Chromatography ProcedureLeadLifeLigandsLung NeoplasmsLung diseasesMass Spectrum AnalysisMedicineMethodsMolecular WeightMonoclonal AntibodiesMusNuclear Magnetic ResonancePharmaceutical PreparationsPharmacologic SubstancePhasePlatinumPreparationProceduresProcessProductionPropertyProtocols documentationQuality ControlRadioRadioactive IodineRadioactive metalRadioisotopesReagentRecombinant ProteinsRefractive IndicesReproducibilityResearchResearch ActivityResearch InstituteResearch Project GrantsResearch SupportResourcesServicesSolid NeoplasmSpectrophotometrySpectroscopy, Fourier Transform InfraredSurface Plasmon ResonanceSynthesis ChemistrySystemTechnical ExpertiseTechnologyTechnology TransferTestingTherapeuticTherapeutic AgentsTherapeutic antibodiesTimeTrainingUniversitiesValidationYangantibody conjugateantibody engineeringcGMP productionchemotherapyclinical imagingclinical translationdetectorexperienceexperimental studyhumanized antibodyimaging agentinstrumentlight scatteringmembernovelpre-clinicalprotein expressionproteogenomicsscale uptargeted imagingtherapeutic evaluationtumor

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中文摘要
翻译
核心B项目总结 Core B Preclinical Therapeutics将提供纯化抗体,用于项目1和2的结合和使用, 产生新的靶向小窝的成像和治疗剂。核心还将提供分析 确保用于临床前动物试验的试剂质量控制的服务。抗体 堆芯B产生的放射性核素将与堆芯D中的放射性核素结合,用于项目1。抗体将 提供给项目2用于与各种化疗结合,并在临床前转移模型中进行测试 疾病项目1和2中开发的试剂将使用分析方法进行严格的质量控制评估。 在用于任何动物研究之前,由核心B提供的服务。核心B还将提供支持服务, 用于临床试验的人源化抗体和治疗剂的cGMP生产指南, 包括规模扩大、工艺开发、验证、批量测试、合规性,并提供技术支持 确保成功的技术转让和成品的高质量生产。
英文摘要
CORE B PROJECT SUMMARY Core B Preclinical Therapeutics will provide purified antibodies for conjugation and use in Projects 1 and 2 to generate novel caveolae-targeting imaging and therapeutic agents. The Core will also provide analytical services to ensure quality control of reagents that will be used for preclinical animal testing. Antibodies generated in Core B will be conjugated to radionuclides in Core D for use in Project 1. Antibodies will be provided to Project 2 for conjugation to various chemotherapies, and testing in preclinical metastatic models of disease. Reagents developed in Projects 1 and 2 will be rigorously evaluated for quality control using analytical services provided by Core B prior to use in any animal studies. Core B will also provide support services and guidance for the cGMP production of the humanized antibody and therapeutic agents destined for clinical trials, including scale-up, process development, validation, batch testing, compliance, and providing technical expertise as needed to ensure successful technology transfer and quality manufacturing of finished goods.
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Preclinical Therapeutics Core
Preclinical Therapeutics Core
Preclinical Therapeutics Core
Caveolae-Targeted Cisplatin Immunoconjugates for Effective Lung Cancer Therapy
  • 批准号:
    9408697
  • 项目类别:
  • 资助金额:
    $30.0万
  • 财政年份:
    2017
  • 负责人:
    Michael David Levin
  • 依托单位:
海外基金