Automated Production of [ 68 Ga]Ga-Desferrioxamine B on Two Different Synthesis Platforms

PET imaging of bacterial infection could potentially provide added benefits for patient care through non-invasive means. [ Ga]Ga-desferrioxamine B-a radiolabelled siderophore-shows specific uptake by human-pathogenic bacteria like or and sufficient serum stability for clinical application. In this report, we present data for automated production of [ Ga]Ga-desferrioxamine B on two different cassette-based synthesis modules (Modular-Lab PharmTracer and GRP 3V) utilising commercially obtainable cassettes together with a licensed Ge/ Ga radionuclide generator. Quality control, including the determination of radiochemical purity, as well as a system suitability test, was set up via RP-HPLC on a C18 column. The two described production processes use an acetic acid/acetate buffer system with ascorbic acid as a radical scavenger for radiolabelling, yielding ready-to-use formulations with sufficient activity yield. Batch data analysis demonstrated radiochemical purity of >95% by RP-HPLC combined with ITLC and excellent stability up to 2 h after synthesis. Specifications for routine production were set up and validated with four masterbatches for each synthesis module. Based on this study, an academic clinical trial for imaging of bacterial infection was initiated. Both described synthesis methods enable automated production of [ Ga]Ga-desferrioxamine B in-house with high reproducibility for clinical application.