cGMP Compliant HPLC for Radiopharmaceutical Quality Control

项目摘要 该申请要求资金购买符合cGMP的现代高压液体 用于放射性药物质量控制的高效液相色谱法（HPLC）系统;待安置， 作为范德比尔特大学成像研究所的共享资源进行管理和利用 科学（VUIIS）放射化学核心实验室。该核心资源允许访问研究 用于三种人体PET/CT成像系统的放射性示踪剂，两种临床前PET成像 系统和各种其他最终用途。该系统将由范德比尔特的研究人员使用 大学和范德比尔特大学医学中心，以及可供使用的 附近的退伍军人事务部和纳什维尔的梅哈里医学院的调查人员说， 美国历史上最古老、最大的黑人健康科学学术中心。拟议 设备是Lablogic Logi-CHROM系统，配有四元泵、双柱 隔室、自动进样器、紫外线和伽马检测器。除了提供软件 专门设计符合21 CFR 11和21 CFR 212， 检测器特别有吸引力，因为它将允许监测多个UV波长 同步拟议的设备将大大提高现有的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.