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NIAID PRECLINICAL DEVELOPMENT SUPPORT - PRODUCTION OF MHRP GP145 CLADE C PROTEIN

NIAID PRECLINICAL DEVELOPMENT SUPPORT - PRODUCTION OF MHRP GP145 CLADE C PROTEIN
NIAID 临床前开发支持 - MHRP GP145 C 类蛋白的生产
批准号：
10335108
负责人：
TIMOTHY FOUTS
金额：
$11.84万
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：
2014-09-19 至 2022-03-31
来源：
https://reporter.nih.gov/project-details/10335108
关键词：
AIDS preventionContractorContractsDevelopmentDocumentationGuidelinesHIV vaccineInvestigational DrugsInvestigational New Drug ApplicationInvestigator-Initiated ResearchModalityNational Institute of Allergy and Infectious DiseasePamphletsPhasePreclinical TestingProcessProductionProtocols documentationResearch PersonnelSafetyTestingauthoritycitrate carrierflexibilityimmunogenicitymicrobicidepreclinical developmentresearch clinical testingresearch study

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中文摘要
翻译
这份合同将为NIAID提供广泛和灵活的非传统、前瞻性和面向开发的能力，当有前景的产品从研究人员发起的研究中出现时，为这些产品提供临床前开发支持。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。承包商应协助NIAID工作人员为小规模生产、临床前测试和文件提供所需的所有支持，以提交第一、第二和第三阶段临床测试的研究用新药(IND)。
英文摘要
This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. The Contractor shall assist NIAID staff in providing all support needed for small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing.
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NIAID Preclinical Development Support: Essential Core Activities
NIAID Preclinical Development Support: Essential Core Activities
cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine
cGMP Manufacture, Fill-Finish, Release, and Stability Testing of a Nanoparticle Based HIV Envelope Containing Vaccine
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