Upgrades and regulatory aspects of [18F]Fluorodeoxyglucose ([18F]FDG) production using the FASTLab2 synthesizer

Abstract

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.