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Task X11: Product Development Plans and Feasibility Assessments

Task X11: Product Development Plans and Feasibility Assessments
任务 X11：产品开发计划和可行性评估
批准号：
10934474
负责人：
JAMES RICHARDSON
金额：
$7.0万
依托单位：
ADVANCED BIOSCIENCE LABORATORIES, INC.
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
项目状态：
已结题
起止时间：
2014-11-06 至 2020-05-01
来源：
https://reporter.nih.gov/project-details/10934474
关键词：
APBA1 geneBiological ProductsBioterrorismClinical ResearchCommunicable DiseasesContractsCyclic GMPDevelopmentDevelopment PlansEmerging Communicable DiseasesPhaseRespiratory Syncytial Virus VaccinesServicesToxicologyUnited States Food and Drug AdministrationVaccinesdrug resistant pathogenmanufacturenovel 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, drug-resistant pathogens, and emerging and re-emerging infectious diseases. This contract also provides for manufacture of challenge material.
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