GMP Production of Gallium-68 from a Cyclotron Using Liquid Targets: Regulatory Aspects
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26/05/2016
Poster
Considering the ever expanding use of gallium-68 (68Ga) based radiopharmaceuticals in clinical applications worldwide, there is a growing interest in producing this nuclide in ways other than the traditional germanium-68/gallium-68 generator. Despite their widespread use and ease of operation, generators are limited in terms of their shelf-life, amount of [68Ga]GaCl3 per elution and time between elutions. Moreover the [68Ga]GaCl3 from the generator presents a serious risk of contamination of the final preparation with the long-lived parent nuclide: 68Ge (half-life 271 days).Considering these limitations we recently proposed a fully automated process for the production of 68Ga-radiopharmaceuticals based on the cyclotron irradiation of a zinc-68(68Zn) target solution via (p,n) reaction followed by subsequent purification and labeling.
F. Alves, V. H. Alves, A. Neves, S. J. do Carmo and A. J. Abrunhosa