Abstract
Radiopharmaceuticals based on ligands targeting the prostate-specific membrane antigen (PSMA) are recognized as the “gold standard” for prostate cancer (PCa) imaging using positron emission tomography (PET). This study presents, for the first time in the Republic of Kazakhstan, the results of adapting an automated one-step radiosynthesis technology and performing a comprehensive quality assessment of the [¹⁸F]PSMA-1007 radiopharmaceutical at the Center for Nuclear Medicine and Oncology (Semey, Abai Region). During the study, the direct nucleophilic radiofluorination protocol was optimized, resulting in a stable radiochemical yield (mean 48%) while reducing the total synthesis time to 35–40 minutes. A full quality control cycle confirmed complete compliance of the final product with the European Pharmacopoeia specifications, including radiochemical purity (97–98%), sterility, and apyrogenicity. The successful implementation of this project represents a strategic milestone in the development of nuclear medicine in Kazakhstan. The validated stability and quality parameters of [¹⁸F]PSMA-1007 provide a scientific and methodological basis for scaling up hightechnology production at future cyclotron facilities across the country. The introduction of this radiopharmaceutical into clinical practice significantly improves the accuracy of prostate cancer staging and recurrence detection in Kazakhstan in accordance with international standards.