Good practices for 68 Ga radiopharmaceutical production

Background The radiometal gallium-68 ( 68 Ga) is increasingly used in diagnostic positron emission tomography (PET), with 68 Ga-labeled radiopharmaceuticals developed as potential higher-resolution imaging alternatives to traditional 99m Tc agents. In precision medicine, PET applications of 68 Ga are widespread, with 68 Ga radiolabeled to a variety of radiotracers that evaluate perfusion and organ function, and target specific biomarkers found on tumor lesions such as prostate-specific membrane antigen, somatostatin, fibroblast activation protein, bombesin, and melanocortin. Main body These 68 Ga radiopharmaceuticals include agents such as [ 68 Ga]Ga-macroaggregated albumin for myocardial perfusion evaluation, [ 68 Ga]Ga-PLED for assessing renal function, [ 68 Ga]Ga- t -butyl-HBED for assessing liver function, and [ 68 Ga]Ga-PSMA for tumor imaging. The short half-life, favourable nuclear decay properties, ease of radiolabeling, and convenient availability through germanium-68 ( 68 Ge) generators and cyclotron production routes strongly positions 68 Ga for continued growth in clinical deployment. This progress motivates the development of a set of common guidelines and standards for the 68 Ga radiopharmaceutical community, and recommendations for centers interested in establishing 68 Ga radiopharmaceutical production. Conclusion This review outlines important aspects of 68 Ga radiopharmacy, including 68 Ga production routes using a 68 Ge/ 68 Ga generator or medical cyclotron, standardized 68 Ga radiolabeling methods, quality control procedures for clinical 68 Ga radiopharmaceuticals, and suggested best practices for centers with established or upcoming 68 Ga radiopharmaceutical production. Finally, an outlook on 68 Ga radiopharmaceuticals is presented to highlight potential challenges and opportunities facing the community.