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 journalArticle

1 Citation (Scopus)

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

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Quality Control
Research
Pyrogens
Limit of Detection
Ethanol
High Pressure Liquid Chromatography
N,N'-bis(2-hydroxy-5-(ethylene-beta-carboxy)benzyl)ethylenediamine N,N'-diacetic acid
Clinical Studies
Ga(III)-DOTATOC

Keywords

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

ASJC Scopus subject areas

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

Cite this

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

In: Nuclear Medicine and Biology, Vol. 53, 10.2017, p. 37-39.

Research output: Contribution to journalArticle

Amor-Coarasa, Alejandro ; Kelly, James M. ; Gruca, Monika ; Nikolopoulou, Anastasia ; Vallabhajosula, Shankar ; Babich, John W. / 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. In: Nuclear Medicine and Biology. 2017 ; Vol. 53. pp. 37-39.
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title = "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 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.",
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T1 - 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

AU - Amor-Coarasa, Alejandro

AU - Kelly, James M.

AU - Gruca, Monika

AU - Nikolopoulou, Anastasia

AU - Vallabhajosula, Shankar

AU - Babich, John W.

PY - 2017/10

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N2 - 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.

AB - 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.

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