Multi-curie production of gallium-68 on a biomedical cyclotron and automated radiolabelling of PSMA-11 and DOTATATE

Abstract Background With increasing clinical demand for gallium-68, commercial germanium-68/gallium-68 ([ 68 Ge]Ge/[ Ga]Ga) generators are incapable of supplying sufficient amounts the short-lived daughter isotope. In this study, we demonstrate a high-yield, automated method producing multi-Curie levels [ Ga]GaCl 3 from solid zinc-68 targets and subsequent labelling to produce clinical-grade Ga]Ga-PSMA-11 Ga]Ga-DOTATATE. Results Enriched were irradiated at up 80 µA with 13 MeV protons 120 min; repeatedly 194 GBq (5.24 Ci) purified gallium-68 in form end purification (EOP) an expected > 370 (> 10 bombardment. A fully dissolution/separation process was completed 35 min. Isolated product analysed according Ph. Eur. monograph accelerator produced found comply all specifications. every instance, radiochemical purity exceeded 99.9% importantly, radionuclidic allow shelf-life 7 h based on metric alone. Fully production 72.2 performed, providing high 98.2%) very apparent molar activities 722 MBq/nmol. Further, manual radiolabelling 3.2 DOTATATE performed yields 95%) (9–25 MBq/nmol) use. Conclusions We have developed high-yielding, , supply proximal radiopharmacies. The reported led record-high (194 purification) PSMA-11 DOTATATE. highly irradiation through formulation product, as such comprised level radiation protection. quality control results obtained both promising