cGMP Compliant HPLC for Radiopharmaceutical Quality Control

用于放射性药物质量控制的符合 cGMP 的 HPLC

• 批准号: 10430807
• 负责人: Todd E Peterson
• 金额: $ 9.14万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2023-09-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10430807
• 关键词: Academic Medical Centers; Clinical Research; Computer software; Cyclic GMP; Equipment; Funding; Health Sciences; High Pressure Liquid Chromatography; Human; Institutes; Laboratories; Modernization; Monitor; Positron-Emission Tomography; Pump; Quality Control; Radiochemistry; Radiopharmaceuticals; Request for Applications; Research; Research Personnel; Research Project Grants; Resource Sharing; Resources; Sampling; System; Therapeutic; United States National Institutes of Health; Universities; X-Ray Computed Tomography; design; detector; imaging science; imaging system; medical schools; pre-clinical; pre-clinical research; radiotracer; single photon emission computed tomography

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.

项目摘要 该申请要求资金购买现代的，符合CGMP的高压液体 色谱（HPLC）系统用于放射性药物的质量控制；被安置， 管理并用作范德比尔特大学成像学院的共享资源 科学（VUIIS）放射化学核心实验室。该核心资源允许访问研究 用于在三个人类PET/CT成像系统上使用的放射性示例，这是两个临床前PET成像 系统和各种其他最终用途。该系统将被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，可用于使用 附近VA和纳什维尔的Meharry医学院的调查人员，这是HBCU 该国最古老，历史上最大的黑人学术健康科学中心。提议 设备是带有第四纪泵的Lablogic Logi-Chrom系统，恒温柱 车厢，自动采样器，紫外线和伽马检测器。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 检测器特别有吸引力，因为它可以监测多个紫外线波长 相似地。拟议的设备将大大增强现有的NIH支持的临床 以及利用正电子排放断层扫描（PET）的临床前研究项目，单照片 排放计算机断层扫描（SPECT）和治疗性放射性药物。