Continuation of comprehensive quality control of the itG 68Ge/68Ga generator and production of 68Ga-DOTATOC and 68Ga-PSMA-HBED-CC for clinical research studies

Abstract

Performance of a second itG ⁶⁸Ge/⁶⁸Ga generator system and production of ⁶⁸Ga-DOTATOC and ⁶⁸Ga-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 ⁶⁸Ge/⁶⁸Ga generator was characterized and the eluate used for preparation of ⁶⁸Ga-DOTATOC and ⁶⁸Ga-PSMA-HBED-CC. Weekly elution profiles of ⁶⁸Ga elution yield and ⁶⁸Ge breakthrough were determined.

Results: ⁶⁸Ga elution yields averaged 82% (61.8-98.4%) and ⁶⁸Ge breakthrough averaged 0.002% (0.0007% to 0.004%). The radiochemical purities of ⁶⁸Ga-DOTATOC and ⁶⁸Ga-PSMA-HBED-CC were determined by HPLC analysis to be >98% and specific activity was 12.6 and 42GBq/μmol, respectively. ⁶⁸Ge contamination in the product was under the detection limit (0.00001%). Final sterile, pyrogen-free formulation of ⁶⁸Ga-DOTATOC and ⁶⁸Ga-PSMA-HBED-CC in physiologic saline with 5%-7% ethanol was achieved.

Conclusion: Performance of a ⁶⁸Ge/⁶⁸Ga generator was studied over one year with satisfactory results. The generator eluate was used to synthesize ⁶⁸Ga-DOTATOC and ⁶⁸Ga-PSMA-HBED-CC on a routine basis in high purity.

Keywords: (68)Ga generator; DKFZ-PSMA-11; DOTATOC; PSMA-HBED-cc; itG generator.