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Production of Ga-68 radiotracers under GMP and regulatory aspects - a German perspective

Neels, O.
Radiopharmaceuticals labelled with the positron emitter Gallium-68 have had an enormous impact on the diagnostic imaging of neuroendocrine tumors using somatostatin receptor ligands and in recent years on the diagnosis of prostate cancer using PSMA ligands and subsequently their application for radioendotherapy using Yttrium-90, Lutetium-177 or more recently Actinium-225. The release of the monographs for ‘Gallium-68 chloride solution for radiolabelling’ and ‘Gallium-68 Edotreotide injection’ within the European Pharmacopoeia in 2013 tightened the requirements for specifications of Gallium-68 labelled radiotracers and will be enhanced with the ongoing elaboration of monographs for ‘Gallium-68 DOTA-TATE injection’, ‘Gallium-68 DOTA-NOC injection’ and ‘68Ga-PSMA’. In the same way the work environment of the responsible radiochemists and radiopharmacists in terms of quality control has been improved but also the workload has reached a high level with the increasing number of clinical applications and the limitation of the maximum achievable amount of starting activity from the currently available generators and therefore a limited dose number. The change of conditions for the production and quality control of Gallium-68 labelled radiopharmaceuticals will be reviewed with regards to legislating and practical aspects from ‘on bench’ to ‘full GMP’ preparation linked to the specific requirements for a multi-centre clinical trial using 68Ga-PSMA-11 in high-risk prostate cancer.
  • Open Access Logo Invited lecture (Conferences)
    4th Theranostics World Congress 2016, 07.-09.11.2016, Melbourne, Australia
    DOI: 10.1530/endoabs.47.OC2

Permalink: https://www.hzdr.de/publications/Publ-31003
Publ.-Id: 31003