Continuation of comprehensive quality control of the itG Ge/Ga generator and production of Ga-DOTATOC and Ga-PSMA-HBED-CC for clinical research studies.

Performance of a second itG Ge/Ga generator system and production of Ga-DOTATOC and Ga-PSMA-HBED-CC were tested over one year as an accompaniment to a previously published study (J Nucl Med. 2016;57:1402-1405).

METHODS: Performance of a 1951MBq Ge/Ga generator was characterized and the eluate used for preparation of Ga-DOTATOC and Ga-PSMA-HBED-CC. Weekly elution profiles of Ga elution yield and Ge breakthrough were determined.

RESULTS: Ga elution yields averaged 82% (61.8-98.4%) and Ge breakthrough averaged 0.002% (0.0007% to 0.004%). The radiochemical purities of Ga-DOTATOC and Ga-PSMA-HBED-CC were determined by HPLC analysis to be >98% and specific activity was 12.6 and 42GBq/μmol, respectively. Ge contamination in the product was under the detection limit (0.00001%). Final sterile, pyrogen-free formulation of Ga-DOTATOC and Ga-PSMA-HBED-CC in physiologic saline with 5%-7% ethanol was achieved.

CONCLUSION: Performance of a Ge/Ga generator was studied over one year with satisfactory results. The generator eluate was used to synthesize Ga-DOTATOC and Ga-PSMA-HBED-CC on a routine basis in high purity.