Version 1
: Received: 26 July 2024 / Approved: 29 July 2024 / Online: 29 July 2024 (08:43:23 CEST)
How to cite:
Kraihammer, M.; Petřík, M.; Rangger, C.; Gabriel, M.; Haas, H.; Nilica, B.; Virgolini, I.; Decristoforo, C. Automated Production of [68Ga]Ga-desferrioxamine B on Two Different Synthesis Platforms. Preprints2024, 2024072268. https://doi.org/10.20944/preprints202407.2268.v1
Kraihammer, M.; Petřík, M.; Rangger, C.; Gabriel, M.; Haas, H.; Nilica, B.; Virgolini, I.; Decristoforo, C. Automated Production of [68Ga]Ga-desferrioxamine B on Two Different Synthesis Platforms. Preprints 2024, 2024072268. https://doi.org/10.20944/preprints202407.2268.v1
Kraihammer, M.; Petřík, M.; Rangger, C.; Gabriel, M.; Haas, H.; Nilica, B.; Virgolini, I.; Decristoforo, C. Automated Production of [68Ga]Ga-desferrioxamine B on Two Different Synthesis Platforms. Preprints2024, 2024072268. https://doi.org/10.20944/preprints202407.2268.v1
APA Style
Kraihammer, M., Petřík, M., Rangger, C., Gabriel, M., Haas, H., Nilica, B., Virgolini, I., & Decristoforo, C. (2024). Automated Production of [<sup>68</sup>Ga]Ga-desferrioxamine B on Two Different Synthesis Platforms. Preprints. https://doi.org/10.20944/preprints202407.2268.v1
Chicago/Turabian Style
Kraihammer, M., Irene Virgolini and Clemens Decristoforo. 2024 "Automated Production of [<sup>68</sup>Ga]Ga-desferrioxamine B on Two Different Synthesis Platforms" Preprints. https://doi.org/10.20944/preprints202407.2268.v1
Abstract
PET imaging of bacterial infection could potentially provide added benefit for patient care by non-invasive means. [68Ga]Ga-desferrioxamine B – a radiolabelled siderophore – shows specific uptake by human-pathogenic bacteria like Staphylococcus aureus or Pseudomonas aeruginosa as well as sufficient serum stability for clinical application. Here, we provide data for automated production of [68Ga]Ga-desferrioxamine B on two different cassette based synthesis modules (Modular-Lab PharmTracer and GRP 3V) using commercially available cassettes together with an approved 68Ge/68Ga radionuclide generator. Quality control including 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, using an acetic acid/acetate buffer system with ascorbic acid as a radiation scavenger for radiolabelling, yield ready-to-use formulations with sufficient activity yield. Batch data showed radiochemical purity of >95 % as determined by RP-HPLC and ITLC as well as excellent stability over 2 hours post production. Specifications for routine production were set up and validated with four master batches for each synthesis module. Based on this study, an academic clinical trial for imaging of bacterial infection was initiated. Both described synthesis methods enable reproducible, automated in-house production of [68Ga]Ga-desferrioxamine B for clinical application.
Copyright:
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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