Establishing 18F-PSMA-1007 Production in Armenia: Radiosynthesis and Comprehensive Quality Control.

Abstract

Background: 18F-prostate-specific membrane antigen (18F-PSMA-1007) is a recognized positron emission tomography (PET) radiotracer commonly used for prostate tumor imaging due to its excellent tumor-to-background contrast and advantageous pharmacokinetics. Although 18F-PSMA-1007 has been extensively manufactured and used in many countries, it has not been available in Armenia until now. The aim of this work is to synthesize 18F-PSMA-1007 for the first time in Armenia for local clinical implementation and to demonstrate the reproducibility of the process.

Objectives: Based on this, the objective of this work was to synthesize 18F-PSMA-1007 with high synthesis efficiency and chemical purity, which would enable us to perform precise studies in the field of prostate cancer diagnosis. The start of its production also represents a major advancement in the country's nuclear medicine capabilities.

Methods: This study presents the initial report of the first successful production of 18F-PSMA-1007 in Armenia, detailing the synthesis method, quality control criteria, and adherence to good manufacturing practices (GMP) standards to ensure safe and efficient clinical use. An 18 MeV cyclotron was used to produce the 18F radioisotope needed for the production of the radiopharmaceutical. Starting ingredients, chromatographic resins, and a semi-automatic device were used in closed lead-shielded cells to synthesize 18F-PSMA-1007. The chemical reaction started after 18F ions were eluted into the reaction vessel using tetrabutylammonium bicarbonate (TBA). Residual solvents were then removed at 110°C for 5 minutes. The fluorination process was carried out using one-step radiolabeling at 95°C for 10 minutes, after which the resulting product was purified on a chromatographic resin for 10 minutes. Finally, 18F-PSMA-1007 was eluted into the dispensing cell. Comprehensive quality control analyses have been carried out in accordance with the guidelines of the European Pharmacopoeia (EP). To demonstrate the reproducibility of the synthesis of 18F-PSMA-1007 at the Radioisotope Production Center, as well as the quality control results, the work also presents the results of two additional syntheses and the corresponding quality control.

Results: The successful synthesis of 18F-PSMA-1007 in Armenia, with a 52.2 % decay not corrected yield and 95 % purity, marks a significant advancement in the country's nuclear medicine capabilities, providing highly sensitive and accurate PET examinations. The product met all specifications.

Conclusions: The start of 18F-PSMA-1007 production locally has become a significant turning point for Armenian nuclear medicine. In addition to providing patients in the nation with access to cutting-edge PET diagnostic techniques, it also opens the door for the domestic radiopharmaceutical industry to grow and concentrate on exports.