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

Alejandro Amor-Coarasa, James M. Kelly, Monika Gruca, Anastasia Nikolopoulou, Shankar Vallabhajosula, John W. Babich

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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 1951 MBq 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 42 GBq/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.

Original languageEnglish (US)
Pages (from-to)37-39
Number of pages3
JournalNuclear Medicine and Biology
Volume53
DOIs
StatePublished - Oct 2017
Externally publishedYes

Keywords

  • DKFZ-PSMA-11
  • DOTATOC
  • Ga generator
  • PSMA-HBED-cc
  • itG generator

ASJC Scopus subject areas

  • Molecular Medicine
  • Radiology Nuclear Medicine and imaging
  • Cancer Research

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