IGF::OT::IGF ANALYSIS OF HIV-1 ENV HOST CELL PROTEINS BY MASS SPECTROMETRY METHOD

开发预防艾滋病毒感染传播的疫苗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/产品的开发提供了越来越多的方法，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。为了弥合翻译开发方面的差距，NIAID特别建议支持两个关键组成部分：流程开发和分析表征活动。该合同将为流程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新药(IND)申请之前启动，并在正在进行的临床试验(第二阶段和第三阶段)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(制造过程开发和优化、分析表征和化验开发)旨在促进潜在的HIV蛋白疫苗在第一、第二和第三阶段临床试验中的进展。

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.