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
该合同支持产品开发活动,这些活动可能涵盖生产和制剂工艺开发到临床研究,包括:中试批次cGMP材料的生产、表征和放行;疫苗稳定性试验;非临床研究的开展,例如,研究性新药(IND)-使毒理学研究成为可能;以及支持产品开发所需的所有检测试剂和试剂的开发、认证和(必要时)验证。
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