Beijing PET Technology Co., Ltd.

The development of a unified and efficient protocol for the automated synthesis of PET imaging agents is crucial for enhancing operational efficiency and safety. This study aimed to streamline the sequential production process of ¹⁸F-fluorodeoxyglucose ([¹⁸F]FDG) and [⁶⁸Ga]Ga-DOTA-TATE with only single cassette and reagents loading using the AllinOne 36-valve synthesis module, with the goal of improving hot cell utilization and minimizing radiation exposure for operators. The protocol was designed to allow for sequential synthesis without the need for repeated hot cell access or waiting for radiation levels to decrease, thereby reducing the time and resources required for PET imaging agent production.

Our study demonstrated the stability and reliability of the newly designed synthesis protocol. The activity yields for two batches of [¹⁸F]FDG were 73 ± 6.2 % and 64 ± 4.7 % (n = 3), respectively, all with synthesis times about 23 min, and with a radiochemical purity consistently over 96 %. For [⁶⁸Ga]Ga-DOTA-TATE, the yield was 71 ± 5.8 % with synthesis times about 18 min (n = 3), with a purity exceeding 97 %. The synthesized products met all quality control criteria, including appearance, pH value, radioactivity concentration, sterility, endotoxin levels, and solvent residue.

The single-cassette protocol significantly improved efficiency and reduced radiation exposure. High yields and purities confirm its clinical feasibility, ensuring PET imaging agent availability. This scalable solution enhances patient care by simplifying the production process and meeting the demands of various patients for different PET imaging agents within a single day, demonstrating its potential in clinical settings.