Background: Glutamate carboxypeptidase II (GCPII), also known as prostate-specific membrane antigen (PSMA) is overexpressed in 90-100% of prostate cancer cells. The radiopharmaceutical [18F]PSMA-1007, recognised as a PET tracer for prostate cancer imaging, is based on PSMA inhibitor [Glu-CO-Lys(2Nal-Amb-Glu-Glu-PyTMA)] bound to the radioisotope Fluorine-18. [18F]Fluoride was obtained via the 18O(p,n)18F reaction using a cyclotron for medical use, while synthesis of [18F]PSMA-1007 was performed with two different platforms: FASTlab2 and NEPTIS® Perform. Both modules enabled synthesis through nucleophilic substitution reaction and subsequent purification in solid phase extraction (SPE). Quality control process was validated according to the current specific monograph (3116) of the European Pharmacopoeia (Ph. Eur.) before clinical use. Results: Twenty syntheses of [18F]PSMA-1007 for each module were performed in order to evaluate and compare radiochemical purity (96.58% ± 1.25 with FASTlab2 vs 95.86% ± 0.79 with NEPTIS® Perform) and decay-corrected radiochemical yield (43.7% ± 3 with FASTlab2 vs 28.5% ± 3.1 with NEPTIS® Perform). Conclusion: Both platforms produced [18F]PSMA-1007 that consistently met all pharmacopoeial quality control standards. However, the FASTlab2 system demonstrated a statistically significant higher decay-corrected radiochemical yield (43.7% ± 3% vs. 28.5% ± 3.1%, p-value < 0.001 after statistical testing). While this yield difference does not impact radiochemical purity or product safety, it may represent a relevant advantage in terms of production efficiency and available activity for clinical use, which may influence the choice of synthesizer.
A comparative assessment of radiochemical purity and yield of [18F]PSMA-1007 production using two different automated synthesis platforms: a head-to-head comparison
Cossandi, Michela;Statuto, Massimo;Migliorati, Elena;Spiazzi, Luigi;Rodella, Carlo;Bellini, Pietro;Rinaldi, Roberto;Camoni, Luca;Dondi, Francesco;Biasiotto, Giorgio;Bertagna, Francesco
2026-01-01
Abstract
Background: Glutamate carboxypeptidase II (GCPII), also known as prostate-specific membrane antigen (PSMA) is overexpressed in 90-100% of prostate cancer cells. The radiopharmaceutical [18F]PSMA-1007, recognised as a PET tracer for prostate cancer imaging, is based on PSMA inhibitor [Glu-CO-Lys(2Nal-Amb-Glu-Glu-PyTMA)] bound to the radioisotope Fluorine-18. [18F]Fluoride was obtained via the 18O(p,n)18F reaction using a cyclotron for medical use, while synthesis of [18F]PSMA-1007 was performed with two different platforms: FASTlab2 and NEPTIS® Perform. Both modules enabled synthesis through nucleophilic substitution reaction and subsequent purification in solid phase extraction (SPE). Quality control process was validated according to the current specific monograph (3116) of the European Pharmacopoeia (Ph. Eur.) before clinical use. Results: Twenty syntheses of [18F]PSMA-1007 for each module were performed in order to evaluate and compare radiochemical purity (96.58% ± 1.25 with FASTlab2 vs 95.86% ± 0.79 with NEPTIS® Perform) and decay-corrected radiochemical yield (43.7% ± 3 with FASTlab2 vs 28.5% ± 3.1 with NEPTIS® Perform). Conclusion: Both platforms produced [18F]PSMA-1007 that consistently met all pharmacopoeial quality control standards. However, the FASTlab2 system demonstrated a statistically significant higher decay-corrected radiochemical yield (43.7% ± 3% vs. 28.5% ± 3.1%, p-value < 0.001 after statistical testing). While this yield difference does not impact radiochemical purity or product safety, it may represent a relevant advantage in terms of production efficiency and available activity for clinical use, which may influence the choice of synthesizer.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
