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Peer-Reviewed Publication
EJNMMI Radiopharm Chem2026June 23, 2026Journal Article

Fully GMP-complient radiosynthesis of [161Tb]Tb-PSMA-1 using the miniAiO synthesizer for clinical translation.

David Kryza1, Pierre Le Fur2, Jean Noël Badel2,3, Clément Morgat4,5, Fouzi Khayi2, Anne-Laure Giraudet2
1Service de Médecine Nucléaire Lumen, Centre Léon Bérard, 69343, Lyon Cedex 08, France. david.kryza@lyon.unicancer.fr.
2Service de Médecine Nucléaire Lumen, Centre Léon Bérard, 69343, Lyon Cedex 08, France.
3CREATIS, CNRS UMR 5220, INSERM U 1044, Université de Lyon, INSA-Lyon, Université Lyon 1, Lyon, France.
4Nuclear Medicine & Radiopharmacy Department, Bordeaux University Hospital, Bordeaux, France.
5INCIA, University of Bordeaux, CNRS, EPHE, UMR 5287, Bordeaux, France.

Abstract

BACKGROUND: Terbium‑161 (161Tb) is an emerging radionuclide for targeted radionuclide therapy that combines β⁻ emissions with short‑range conversion and Auger electrons, increasing its efficacy against micrometastatic and low‑volume prostate cancer. This study aimed to develop, optimize, and validate a fully automated good manufacturing practice (GMP)-compliant radiosynthesis of [161Tb]Tb-PSMA‑1 f…

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