Fonseca, A.I.; Alves, V.H.; Hrynchak, I.; Alves, F.; Abrunhosa, A.J. Fully Automated Production of [68Ga]GaFAPI-46 with Gallium-68 from Cyclotron Using Liquid Targets. Int. J. Mol. Sci.2023, 24, 15101.
Fonseca, A.I.; Alves, V.H.; Hrynchak, I.; Alves, F.; Abrunhosa, A.J. Fully Automated Production of [68Ga]GaFAPI-46 with Gallium-68 from Cyclotron Using Liquid Targets. Int. J. Mol. Sci. 2023, 24, 15101.
Fonseca, A.I.; Alves, V.H.; Hrynchak, I.; Alves, F.; Abrunhosa, A.J. Fully Automated Production of [68Ga]GaFAPI-46 with Gallium-68 from Cyclotron Using Liquid Targets. Int. J. Mol. Sci.2023, 24, 15101.
Fonseca, A.I.; Alves, V.H.; Hrynchak, I.; Alves, F.; Abrunhosa, A.J. Fully Automated Production of [68Ga]GaFAPI-46 with Gallium-68 from Cyclotron Using Liquid Targets. Int. J. Mol. Sci. 2023, 24, 15101.
Abstract
68Ga-based radiopharmaceuticals are routinely used for PET imaging of multiple types of tumors tumours. Gallium-68 is commonly obtained from 68Ge/68Ga generators, which are limited in the quantity of activity produced. Alternatively, gallium-68 can easily be produced on a cyclotron using liquid targets. In this study we optimized the GMP production of [68Ga]GaFAPI-46 using gallium-68 produced from a standard medical cyclotron using liquid targets. Starting from the published synthesis and quality control procedures described for other 68Ga-based radiopharmaceuticals, we have validated the synthesis process and the analytical methods to test the quality parameters of the final product to be used for routine clinical studies. [68Ga]GaFAPI-46 was successfully produced with high radiochemical purity and yield using an IBA Synthera® Extension module. Gallium chloride was cyclotron produced on a medical cyclotron using a liquid target with an activity of 4.31 ± 0.36 GBq at the end-of-purification (EOP). Analytical methods were established and validated meeting Ph. Eur. standards. Fully GMP production was also validated in three consecutive batches, producing 2.50 ± 0.46 GBq of [68Ga]Ga-FAPI-46 at the end-of-synthesis (EOS), with 98.94 ± 0.72% radiochemical purity by radio-HPLC. Quality was maintained for up to 3 h after the EOS. Production of [68Ga]GaFAPI-46 was performed and validated using a standard medical cyclotron with liquid targets. Quality control parameters (e.g. sterility, purity, and residual solvents) conform to Eur. Phar. and shelf life of 3 h was established. Activity of [68Ga]GaFAPI-46 produced is substantially higher than the one obtained with generators enabling a better response to the clinical need for this radiopharmaceutical.
Chemistry and Materials Science, Inorganic and Nuclear Chemistry
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