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.