Alejandro Amor-Coarasa1, James M Kelly1, Monika Gruca2, Anastasia Nikolopoulou3, Shankar Vallabhajosula1, John W Babich4. 1. Division of Radiopharmaceutical Sciences, Department of Radiology, Weill Cornell Medicine, New York, NY 10021, USA. 2. Citigroup Biomedical Imaging Center, Weill Cornell Medicine, New York, NY 10021, USA. 3. Division of Radiopharmaceutical Sciences, Department of Radiology, Weill Cornell Medicine, New York, NY 10021, USA; Citigroup Biomedical Imaging Center, Weill Cornell Medicine, New York, NY 10021, USA. 4. Division of Radiopharmaceutical Sciences, Department of Radiology, Weill Cornell Medicine, New York, NY 10021, USA; Citigroup Biomedical Imaging Center, Weill Cornell Medicine, New York, NY 10021, USA; Meyer Cancer Center, Weill Cornell Medicine, New York, NY 10021, USA. Electronic address: job2060@med.cornell.edu.
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.
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.
Authors: Costantina Maisto; Michela Aurilio; Anna Morisco; Roberta de Marino; Monica Josefa Buonanno Recchimuzzo; Luciano Carideo; Laura D'Ambrosio; Francesca Di Gennaro; Aureliana Esposito; Paolo Gaballo; Valentina Pirozzi Palmese; Valentina Porfidia; Marco Raddi; Alfredo Rossi; Elisabetta Squame; Secondo Lastoria Journal: Molecules Date: 2022-06-16 Impact factor: 4.927
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