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Endocrine Abstracts (2016) 47 OC49 | DOI: 10.1530/endoabs.47.OC49

1ICNAS, University of Coimbra, Coimbra, Portugal; 2RadioPharma Solutions, IBA SA, Louvain-la-neuve, Belgium.


The use of gallium-68 (68Ga) is rapidly expanding with new applications arising almost every week. Therefore, the global availability of this nuclide is a critical issue. 68Ga is currently sourced from commercial 68Ge/68Ga generators but their production is limited by the availability of the parent nuclide 68Ge. Alternatively, the use of a 68Zn salt solution in a liquid target has been proposed [1] [2]. With this process, 68Ga can be produced in a cyclotron as simply as 18F or 13N. In this paper, a fully automated and GMP-optimized production of 68Ga with a liquid target on a mid-energy cyclotron is described including purification and final peptide labeling using commercial target and synthesis modules (patent application: EP15170854).

A fully automated process was implemented. A minimum of 180 mCi of 68Ga was systematically produced on a 40 min irradiation at 45 uA proton beam using 100 mg of 68Zn solution using an IBA Cyclone 18/9 cyclotron. Purification was performed in about 30 min with >85% yield (d.c.) using a Synthera Extension module and labeling of the final peptide (68Ga-DOTANOC or 68Ga-PSMA-11) was made on a Synthera synthesizer with >70% yield (d.c.) in less than 25 min. Zn and Fe impurities were all below 5 ppm and radionuclidic purity of the final formulation was >99%.

In summary, a final solution of 68Ga radiopharmaceuticals suitable for human use can be produced, with practical and economical gains compared with the conventional generator method. This process can also be adapt for the cold kit labelling system.

References

1. M.K. Pandey, J.F. Byrne, H. Jiang, A.B. Packard, T.R. DeGrado: Am J Nucl Med Mol Imaging 4 (4), pp. 303–310, 2014.

2. M. Jensen, J. Clark; Proceedings of the 13th International Workshop on Targetry and Target Chemistry, pp. 288–289, 2011.

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