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Task X20:Master Cell Banks

Task X20:Master Cell Banks
任务 X20：主细胞库
批准号：
10329655
负责人：
JAMES RICHARDSON
金额：
$6.71万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
项目状态：
已结题
起止时间：
2016-05-12 至 2021-06-30
来源：
https://reporter.nih.gov/project-details/10329655
关键词：
BiologicalBioterrorismClinical ResearchCommunicable DiseasesContractsCyclic GMPDevelopmentDevelopment PlansEmerging Communicable DiseasesPhaseServicesToxicologyUnited States Food and Drug AdministrationVaccinesZika virus vaccinecell banknovel vaccinesproduct developmentvaccine development

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中文摘要
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英文摘要
The Manufacture and Characterization Services (MCS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services spanning product development planning and feasibility assessments; product development and cGMP compliant manufacture for Phase I/II clinical studies; toxicology studies; technical and facility audits; and regulatory support appropriate for submission to the U.S. Food and Drug Administration (FDA). These services will facilitate the development and introduction of new vaccines and biologics against potential agents of bioterrorism and emerging and re-emerging infectious diseases. This contract also provides for manufacture of challenge material.
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