NIAID Process Development and Analytical Support for Development of HIV Vaccines

国家过敏和传染病研究所的进程发展和对研制艾滋病毒疫苗的分析性支持：研制预防艾滋病毒感染蔓延的疫苗是国家过敏和传染病研究所的最高优先事项之一。虽然免疫学和分子生物学的进展继续为开发新疫苗/产品提供越来越多的方法，但将基础研究成果应用于临床的转化开发能力和专门知识有限。为了弥合转化开发的差距，NIAID特别建议支持两个关键组成部分：工艺开发和分析表征活动。该合同将为工艺开发和分析特性提供有针对性的专业技术和设备。这些活动在提交研究新药（IND）申请之前启动，并在正在进行的临床试验（2期和3期）期间作为产品开发/化学、制造和控制（CMC）活动的一部分继续进行。获得产品开发活动（生产工艺开发和优化、分析表征和测定开发）的目的是促进潜在的HIV蛋白疫苗在1、2和3期临床试验中的进展。

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.