Production of 2-[18F]Fluoro-2-deoxy-D-glucose radiopharmaceutical at the University Institute of Positron Emission Tomography, Skopje

Abstract

Fludeoxyglucose (18F) injection is a sterile solution of fluorine-18 in the form of 2-deoxy-2-[18F]fluoro-α-Dglucopyranose, intended for intravenous administration. [18F]FDG is the most widely used radiopharmaceutical for molecular imaging by positron emission tomography (PET). University Institute of Positron Emission Tomography in Skopje is a GMP facility for production of radiopharmaceuticals, equipped with a cyclotron for production of radioisotopes and specially designed radiochemical laboratories for production and quality control. [18F]FDG production laboratory is equipped with a double hot cell for synthesis where two fully automated modules for [18F]FDG synthesis - Synthera V2 are placed, and a hot cell for dispensing with automatic dispensing system for radiopharmaceuticals – volumetric dispenser Clio. The production process starts by F-18 radioisotope production in the cyclotron and continues with a synthesis of [18F]FDG radiopharmaceutical in the synthesis module. The synthesis is based on nucleophilic substitution of radioisotope with mannose triflate as precursor, followed by basic hydrolysis. The last step of the synthesis is a purification of [18F]FDG. When the synthesis of the radiopharmaceutical is finished, next phase is quality control of the final product and dispensing of the doses for patients.