cGMP Compliant HPLC for Radiopharmaceutical Quality Control

项目总结

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.