cGMP Compliant HPLC for Radiopharmaceutical Quality Control

项目摘要 此应用程序请求资金来购买符合cGMP标准的现代高压液体 用于放射性药物质量控制的色层分析(高效液相)系统； 作为范德比尔特大学成像研究所内的共享资源进行管理和利用 科学(VUIIS)放射化学核心实验室。此核心资源允许访问研究 用于三个人体PET/CT成像系统、两个临床前PET成像系统的放射性示踪剂 系统和各种其他终端用途。范德比尔特大学的研究人员将使用该系统 大学和范德比尔特大学医学中心，并可供 附近退伍军人事务部和纳什维尔的梅哈里医学院的调查人员，HBCU是 美国历史上最古老、规模最大的黑人学术健康科学中心。建议数 设备为Lablogic Logi-Chrom系统，带有四元泵、恒温柱 隔间，自动取样器，紫外线和伽马探测器。除了提供软件 该系统的二极管阵列专门设计为符合21 CFR 11和21 CFR 212 探测器特别有吸引力，因为它将允许监测多个紫外线波长 同时。拟议的设备将极大地增强现有的NIH支持的临床 和临床前研究项目，利用正电子发射断层扫描(PET)、单光子 发射计算机断层扫描(SPECT)和治疗性放射性药物。

Project Summary This application requests funds to purchase a modern, cGMP-compliant high-pressure liquid chromatography (HPLC) system for use in quality control of radiopharmaceuticals; to be housed, managed, and utilized as a Shared Resource within the Vanderbilt University Institute of Imaging Science (VUIIS) Radiochemistry Core Laboratory. This Core resource allows access to research radiotracers for use on three human PET/CT imaging systems, two pre-clinical PET imaging systems and a variety of other end uses. The system will be utilized by researchers at Vanderbilt University and Vanderbilt University Medical Center, as well as being available for use by investigators at the nearby VA and Nashville’s Meharry Medical College, an HBCU that is one of the nation’s oldest and largest historically black academic health science centers. The proposed equipment is a Lablogic Logi-CHROM system with quaternary pump, thermostatic column compartment, auto-sampler, UV and gamma detectors. In addition to providing software specifically designed to be compliant with 21 CFR 11 and 21 CFR 212, the system’s diode array detector is particularly attractive as it will allow for monitoring of multiple UV wavelengths simultaneously. The proposed equipment will greatly enhance the existing NIH-supported clinical and preclinical research projects that utilize positron emission tomography (PET), single photon emission computed tomography (SPECT), and therapeutic radiopharmaceuticals.