The production of [ 18 F]Fluorodeoxyglucose ([ 18 F]FDG) using a GE FASTLab2 synthesizer enables to obtain higher radiochemical yields including more robust synthesis process. This work evaluates the performance of GE FASTlab2 and discusses further the regulatory aspects of upgrading a synthesizer. The analytical results after end of synthesis (EOS) demonstrate the superiority of the GE FASTlab2 (71.3% ± 6.7) versus GE Tracerlab MX FDG (57.7% ± 4.2). The FDG Duo performance showed high radiochemical yields after EOS with 72.5% ± 1.5 and 72.9% ± 2.0 for the first and second run. The radiochemical purity for the GE FASTlab2 synthesizer amounted to 99.78% ± 0.1. No radiolabeled intermediate compound (FTAG) was present in the final product solution. These good results were obtained by different FASTlab2 cassette modifications and the synthesis steps involved. Thus a higher amount of precursor, an improved FTAG trapping method, the use of tC18 long plus cartridge, novel FASTlab2 cassette valve design, and nitrogen gas flushing of final tubing was applied. Additionally, this work deals with regulatory aspects which had to be fulfilled during the upgrading process.
Designing and implementing various radionuclide production methods guarantees a sustainable supply, which is important for medical use. The use of medical cyclotrons for radiometal production can increase the availability of gallium-68 (68Ga) radiopharmaceuticals. Although generators have greatly influenced the demand for 68Ga radiopharmaceuticals, the use of medical cyclotrons is currently being explored. The resulting 68Ga production is several times higher than obtained from a generator. Moreover, the use of solid targets yields end of purification and end of synthesis (EOS) of up to 194 GBq and 72 GBq, respectively. Furthermore, experiments employing liquid targets have provided promising results, with an EOS of 3 GBq for [68Ga]Ga-PSMA-11. However, some processes can be further optimized, specifically purification, to achieve high 68Ga recovery and apparent molar activity. In the future, 68Ga will probably remain one of the most in-demand radionuclides; however, careful consideration is needed regarding how to reduce the production costs. Thus, this review aimed to discuss the production of 68Ga radiopharmaceuticals using Advanced Cyclotron Systems, Inc. (ACSI, Richmond, BC, Canada) Richmond, Canada and GE Healthcare, Wisconsin, USA cyclotrons, its related factors, and regulatory concerns.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.