Developed and validated script for 18F – PSMA -1007 Synthesis in IBA – Synthera version-01

Introduction: Prostate cancer is the most common cancer in men worldwide. As per available at the American cancer society, one out nine men has the probability of getting diagnosed positive for prostate cancer. It is the second leading cause of death in men worldwide. Prostate-specific antigen (PSA) is a common biomarker indicating prostate cancer. Radioisotope labelled Prostate-specific membrane antigen (PSMA) is an exciting agent for early diagnosis and treatment of prostate cancer. PSMA is over-expressive in the prostate cancer cell. As per the clinical requirement of PSMA in the nuclear medicine department, as a service provider, we thought to produce and supply the 18F-PSMA-1007. We developed our script for ¹⁸F-PSMA -1007 synthesis for IBA-Synthera Version 01 and validated it. As per my knowledge, our facility is the first one synthesising ¹⁸F-PSMA -1007 commercially with IBA-Synthera Version-01.

Methods: We used IBA-Synthera Version-01 with MPB software. Integrated Fluid Processor (IFP), Reagents and PSMA-1007 precursor obtained from M/s ABX, Germany. Used self-developed ¹⁸F-PSMA -1007 synthesis script and synthesized the same. Total script time is 33 minutes, with improved precursor reaction time and cleaning steps.

Results: ¹⁸F-PSMA -1007 was tested in 10 batches for the quality of the product. Radiochemical purity was always > 90%. pH, residual solvents and endotoxins were within limits. The typical yield varies between 35 – 48 %. It was observed that radiochemical purity starts decreasing beyond 2.5 to 3.0 Ci of ¹⁸F-PSMA-1007.

Conclusions: We find the produced ¹⁸F-PSMA -1007; meet all the quality requirements as per current standard. Reproducibility in product yield and quality has also been seen.