Process Development for Cell Culture, Upstream and Downstream Process in Production of HIV-1 Biomolecules
细胞培养工艺开发、HIV-1 生物分子生产的上游和下游工艺
基本信息
- 批准号:10003879
- 负责人:
- 金额:$ 172.68万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2019
- 资助国家:美国
- 起止时间:2019-08-15 至 2020-08-14
- 项目状态:已结题
- 来源:
- 关键词:Basic ScienceCell Culture TechniquesChemistryClinicClinical TrialsContractsDevelopmentHIVHIV InfectionsHIV vaccineHIV-1ImmunologyInvestigational New Drug ApplicationMolecular BiologyMonoclonal AntibodiesNational Institute of Allergy and Infectious DiseasePhaseProcessProductionProteinsVaccinesassay developmentbaseenv Gene Productsmanufacturing process developmentnovel vaccinesparticlepreventproduct developmentvaccine development
项目摘要
NIAID Process Development and Analytical Support for Development of HIV Vaccines: The development of vaccines to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity and expertise for translational development to move basic research findings into the clinic. To bridge the gap in translational development, NIAID specifically proposes to support two key critical components: process development and analytical characterization activities. This contract will provide targeted specialized expertise and facilities for process development and analytic characterization. These activities are initiated prior to filing an Investigational New Drug (IND) application and continue as part of product development/chemistry, manufacturing, and control (CMC) activities during ongoing clinical trials (Phase 2 and 3). Access to product development activities (manufacturing process development and optimization, analytical characterization and assay development) is intended to facilitate the progression of potential HIV protein vaccines in Phase 1, 2, and 3 clinical trials.
NIAID艾滋病毒疫苗开发过程开发和分析支持:预防艾滋病毒感染传播的疫苗开发是国家过敏和传染病研究所(NIAID)的最高优先事项之一。虽然免疫学和分子生物学的进步继续为新疫苗/产品的开发提供了不断扩大的方法,但将基础研究成果转化为临床的转化开发能力和专业知识有限。为了弥合转化开发中的差距,NIAID特别提出支持两个关键的关键组成部分:工艺开发和分析表征活动。该合同将为工艺开发和分析表征提供有针对性的专业知识和设施。这些活动在提交研究性新药(IND)申请之前启动,并在正在进行的临床试验(II期和III期)期间继续作为产品开发/化学、生产和控制(CMC)活动的一部分。参与产品开发活动(生产工艺开发和优化、分析表征和检测开发)旨在促进潜在HIV蛋白疫苗在I、II和III期临床试验中的进展。
项目成果
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{{ truncateString('ANTU DEY', 18)}}的其他基金
Nanoparticle-based Development for HIV-1 Biomolecule Delivery
基于纳米颗粒的 HIV-1 生物分子传递开发
- 批准号:
10398754 - 财政年份:2019
- 资助金额:
$ 172.68万 - 项目类别:
Antigen-Adjuvant Formulation and Characterization Studies
抗原佐剂配方和表征研究
- 批准号:
10003878 - 财政年份:2019
- 资助金额:
$ 172.68万 - 项目类别:
Product Development Plans to Support HIV Vaccine Manufacturing Efforts
支持艾滋病毒疫苗生产的产品开发计划
- 批准号:
9572054 - 财政年份:2017
- 资助金额:
$ 172.68万 - 项目类别:
Feasibility Assessment of HIV Env Protein Antigens
HIV包膜蛋白抗原的可行性评估
- 批准号:
9567366 - 财政年份:2017
- 资助金额:
$ 172.68万 - 项目类别:
IGF::OT::IGF PURIFICATION OF HIV ENV PROTEINS WITH AN IMMUNOAFFINITY BASED PROCESS
IGF::OT::IGF 使用基于免疫亲和力的工艺纯化 HIV ENV 蛋白
- 批准号:
9361990 - 财政年份:2016
- 资助金额:
$ 172.68万 - 项目类别:
IGF::OT::IGF ANALYSIS OF HIV-1 ENV HOST CELL PROTEINS BY MASS SPECTROMETRY METHOD
通过质谱法对 HIV-1 ENV 宿主细胞蛋白进行 IGF::OT::IGF 分析
- 批准号:
9361989 - 财政年份:2016
- 资助金额:
$ 172.68万 - 项目类别:
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