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IGF::OT::IGF NIAID PRECLINICAL DEVELOPMENT SUPPORT - PRODUCTION OF CGMP NATIVE FLEXIBLY LINKED HIV-1 ENVELOPE PROTEIN

IGF::OT::IGF NIAID PRECLINICAL DEVELOPMENT SUPPORT - PRODUCTION OF CGMP NATIVE FLEXIBLY LINKED HIV-1 ENVELOPE PROTEIN
IGF::OT::IGF NIAID 临床前开发支持 - CGMP 天然柔性连接 HIV-1 包膜蛋白的生产
批准号：
9361947
负责人：
THOMAS VANCOTT
金额：
$611.04万
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：
2016-09-12 至 2021-08-28
来源：
https://reporter.nih.gov/project-details/9361947
关键词：
AIDS preventionContractsDataDevelopmentDocumentationGuidelinesHIV vaccineHIV-1Investigational DrugsInvestigational New Drug ApplicationInvestigator-Initiated ResearchLinkModalityNational Institute of Allergy and Infectious DiseasePamphletsPhasePreclinical TestingProcessProductionProtocols documentationResearch PersonnelSafetyTestingauthoritycGMP productionenv Gene Productsflexibilityimmunogenicitymicrobicidepre-clinicalresearch clinical testingresearch study

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中文摘要
翻译
该合同将为NIAID提供广泛而灵活的非传统，主动和以开发为导向的能力，为有前途的产品提供临床前开发支持，当这些产品从制药商发起的研究中出现时。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。活动包括但不限于小规模生产、临床前试验和文件编制，以提交研究性新药（IND）进行I、II和III期临床试验。 特别是，该项目用于生产cGMP HIV-1包膜蛋白。
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. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. In particular this project is for the production of cGMP HIV-1 envelope protein.
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Essential Core Activities: NIAID Preclinical Development Support
NIAID Preclinical Development Support: Adjuvants for HIV-1 Vaccines
ESSENTIAL CORE ACTIVITIES, NIAID PRECLIN DEVELOPMENT SUPPORT
Essential Core Activities: NIAID Preclinical Development Support
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