Preparation of [68Ga]Ga-Chloride from 68Zn solid target for the synthesis of pharmaceutical grade [68Ga]Ga-PSMA-11 and [68Ga]Ga-DOTA-TATE

68Ga is produced from enriched zinc-68 target electrodeposited on copper base material which was irradiated with 15 MeV proton energy in 30 MeV cyclotron. A modified semi-automated separation and purification module was used to obtain pharmaceutical grade [68Ga]GaCl3 in 35 +/- 5 min. The quality of [68Ga]GaCl3 produced was in accordance with Pharmeuropa 30.4. The [68Ga]GaCl3 was utilized for the formulation of multiple doses of [68Ga] Ga-PSMA-11 and [68Ga]Ga-DOTATATE. The quality of [68Ga]Ga-PSMA-11 and [68Ga]Ga-DOTATATE were also in accordance with Pharmacopeia.

Automated summary

68Ga is produced by irradiating enriched zinc-68 target electrodeposited on copper base material with 15 MeV proton energy in a 30 MeV cyclotron. A modified semi-automated separation and purification module is used to obtain pharmaceutical grade [68Ga] GaCl3 within 35 +/- 5 min. The quality of [68Ga]GaCl3, [68Ga]Ga-PSMA-11, and [68Ga]Ga-DOTATATE meets the requirements of the respective pharmacopeia standards.