RADIOSYNTHESIS OF 68GA-PSMA-HBEDcc AGENT USING TRASIS MINIAIO®SYNTHESIZER (SMARTMEDIX TM).

Objectives The goal of these studies was to validate a fully automated method of production of 68Ga-PSMA-HBEDcc radiotracer using ITG GmbH 68Ge/68Ga generator and programmable miniAIO synthesis module (SmartMedix TM) made by Trasis SA. All commercially available miniAIO manifolds were applied in these 68Ga-PSMA-HBEDcc dose formulation studies.

Methods The automated radiosynthesis of 68Ga-PSMA-HBEDcc was performed according to the manual protocol developed for the clinical dose preparation using ITG GmbH generator. Briefly, the 5ug of PSMA-HBEDcc formulated in solution of 0.3M sodium acetate buffer (pH=5.5) and 5mg of ascorbic acid was transferred first to the reaction vial, followed by delivery of 4mL of 152 -563 MBq 68Ga eluted from the generator. The labeling of the dose was completed at temp. 90C for 5min. The final product was formulated in 0.9% saline solution to produce a final dose ready for QC sampling prior to administration. The quality control of the product included its radiochemical/radionuclide characterization, osmolality test, pH determination, endotoxin and 68Ge breakthrough tests.

Results The 68Ga-PSMA-HBEDcc doses were delivered with reproducible radiochemical yield of 81.2%± 4.4 (non-decay corrected). The radiochemical purity of 68Ga-PSMA-HBEDcc was always higher than 99% as determined by radioHPLC and radio-iTLC chromatography. The reaction was completed within 18 min (including the formulation of the final dose) on Trasis MiniAIO module and there was no need for C18 post-purification of the final clinical dose.

Conclusions We have validated the protocol for 68Ga-PSMA clinical doses production using Trasis miniAIO® module and confirmed its compliance with FDA guidelines. The automation minimizes the user exposure during dose preparation, simplifies the required cGMP documentation for each batch dose book and allows for production of multiple doses of 68Ga-PSMA that can be further dispensed by radiopharmacist. This protocol will be implemented for the clinical dose preparation of 68Ga-PSMA agents.