VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES
VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES
批准号:
9539145
负责人:
HOWARD TRANTER
金额:
$641.24万
依托单位:
--
依托单位国家:
美国
项目类别:
财政年份:
2012
资助国家:
美国
项目状态:
已结题
起止时间:
2012-09-27 至 2017-12-31
中文摘要
该合同支持的产品开发活动可能跨越通过临床研究进行的制造和配方过程开发,包括:生产、表征和发布中试批次的cGMP材料;疫苗稳定性测试;进行非临床研究,例如支持新药研究的毒理学研究;以及支持产品开发所需的所有分析和试剂的开发、鉴定和验证(如有必要)。
英文摘要
This contract supports product development activities that may span manufacturing and formulation process development through clinical studies, including: manufacturing, characterization and release of pilot lot cGMP material; vaccine stability testing; conduct of non-clinical studies, e.g., Investigational New Drug (IND)-enabling toxicology studies; and development, qualification and, where necessary, validation of all assays and reagents needed to support product development.
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VACCINE TECHNOLOGIES TO ADVANCE NEXT GENERATION ANTHRAX VACCINES
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批准号:9918809
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项目类别:
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资助金额:$499.97万
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财政年份:2012
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负责人:HOWARD TRANTER
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依托单位:--
海外基金