IGF::OT::IGF GENE THERAPY RESOURCE PROGRAM (GTRP) LENTIVIRUS VECTOR PRODUCTION CORE LABORATORY FOR DR. YUPO MA RSA 1285, FEBRUARY 16, 2017 THROUGH MAY 31, 2017.
IGF::OT::IGF GENE THERAPY RESOURCE PROGRAM (GTRP) LENTIVIRUS VECTOR PRODUCTION CORE LABORATORY FOR DR. YUPO MA RSA 1285, FEBRUARY 16, 2017 THROUGH MAY 31, 2017.
批准号:
9581232
负责人:
KENNETH CORNETTE
金额:
$24.33万
依托单位国家:
美国
项目类别:
财政年份:
2017
资助国家:
美国
项目状态:
已结题
起止时间:
2017-02-21 至 2017-05-31
关键词:
Animal ModelClinicalClinical ResearchContractorContractsDoseFundingGene TransferLaboratoriesLentivirus VectorNational Heart, Lung, and Blood InstitutePharmacology and ToxicologyProductionRegulationResearch PersonnelResourcesSafetyTestingUnited States Food and Drug Administrationgene therapyprogramsvector
中文摘要
慢病毒载体生产核心实验室合同涉及根据食品和药物管理局(FDA)定义的良好制造规范(GMP)以及适用的州和联邦法规生产可扩展的临床级慢病毒载体,供NHBLI资助的研究人员使用。预计承包商将平均每年生产十二(12)批病媒,至少三(3)批用于临床研究或用于大型动物模型的安全性和有效性/剂量/药理学/毒理学测试。
英文摘要
The Lentiviral vector production core laboratory contract involves production of scalable clinical grade Lentiviral vectors, in accordance with Good Manufacturing Practices (GMP), as defined by the Food and Drug Administration (FDA), and applicable State and Federal regulations, for use by NHBLI funded investigators. It is expected that the contractor will produce an average of Twelve (12) vector batches per year for a minimum of three (3) batches for clinical studies or for safety and efficacy/dose/pharmacology/toxicology testing with large animal models.
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国内基金
海外基金
Molecular Interaction Reconstruction of Rheumatoid Arthritis Therapies Using Clinical Data
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批准号:31070748
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项目类别:面上项目
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资助金额:34.0万元
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批准年份:2010
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负责人:Christine Nardini
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依托单位: