Automated GMP-Compliant Production of [68Ga]Ga-DO3A-Tuna-2 for PET Microdosing Studies of the Glucagon Receptor in Humans
Pharmaceuticals August 1, 2020 Michael Wagner, Johan G. Doverfjord, Joachim Tillner et al.
A fully automated, GMP-compliant manufacturing process was developed for the radiopharmaceutical [68Ga]Ga-DO3A-VS-Cys40-Tuna-2, which binds specifically to the glucagon receptor (GCGR). The process achieved a non-decay-corrected radiochemical yield of 45.2 ± 2.5% with a synthesis time of 38 minutes and a quality control release procedure of 20 minutes. The radiochemical purity was 98.9 ± 0.6%, and the product was stable at ambient temperature for at least 2 hours. All acceptance criteria for radionuclidic purity, sterility, endotoxin content, residual solvents, and filter integrity were met. The validated tracer was subsequently used in a clinical study to quantify GCGR occupancy by a dual anti-diabetic drug in humans.