An updated radiosynthesis of [18F]PSMA-1007 by a Neptis RS synthesizer with fully EP compliant quality control test at the medical center in Northern Taiwan

1Chi-Wei Chang,1 Hsin-En Tsai, 2Ching-Huang Lo, 1Ya-Yao Huang*

1 Primo Biotechnology Co., Ltd., Taipei, Taiwan
2 Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan

This study poster was presented at 2024 Annual Conference of Society of Nuclear Medicine, Taiwan.

This study reports on the GMP-compliant process for the preparation of [18F]PSMA-1007 using a Neptis RS synthesizer, with quality control testing according to the European Pharmacopeia (EP), for use in PET imaging of prostate cancer. This procedure was successfully approved for clinical trials at a medical center in northern Taiwan and received IND approval from the Taiwan FDA (TFDA) for PSMA-related clinical research.

The results showed that the [18F]PSMA-1007 synthesized by this process had a radiochemical purity greater than 95%, a pH of 7.5, and met sterility and pyrogen-free standards, satisfying the European Pharmacopeia requirements for purity and stability. The overall process was found to be stable and reliable, suitable for clinical imaging research in prostate cancer, and demonstrated its feasibility for high yield, high quality and GMP compliance in a medical center.