Procedures for the GMP-Compliant Production and Quality Control of [18F]PSMA-1007: A Next Generation Radiofluorinated Tracer for the Detection of Prostate Cancer
| Autor: | Sandra Hübner, René Smits, Ronny Hesse, Klaus Weber, Alexander Hoepping, René Martin, Oliver C. Neels, Yvonne Remde, Antje Hienzsch, Jens Cardinale, Heike Marx, Marco Müller, Klaus Kopka, Anna-Maria Zerges, Martin Schäfer |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Pharmaceutical Science
lcsh:Medicine lcsh:RS1-441 High yielding 030218 nuclear medicine & medical imaging lcsh:Pharmacy and materia medica 03 medical and health sciences Prostate cancer 0302 clinical medicine Drug Discovery PSMA Medicine Rather poor [18F]PSMA-1007 Daily routine Membrane antigen automation fluorine-18 prostate cancer PET business.industry Radiochemistry Radiosynthesis lcsh:R medicine.disease 030220 oncology & carcinogenesis Molecular Medicine business Nuclear medicine |
| Zdroj: | Pharmaceuticals, Vol 10, Iss 4, p 77 (2017) Pharmaceuticals; Volume 10; Issue 4; Pages: 77 |
| ISSN: | 1424-8247 |
| Popis: | Radiolabeled tracers targeting the prostate-specific membrane antigen (PSMA) have become important radiopharmaceuticals for the PET-imaging of prostate cancer. In this connection, we recently developed the fluorine-18-labelled PSMA-ligand [18F]PSMA-1007 as the next generation radiofluorinated Glu-ureido PSMA inhibitor after [18F]DCFPyL and [18F]DCFBC. Since radiosynthesis so far has been suffering from rather poor yields, novel procedures for the automated radiosyntheses of [18F]PSMA-1007 have been developed. We herein report on both the two-step and the novel one-step procedures, which have been performed on different commonly-used radiosynthesisers. Using the novel one-step procedure, the [18F]PSMA-1007 was produced in good radiochemical yields ranging from 25 to 80% and synthesis times of less than 55 min. Furthermore, upscaling to product activities up to 50 GBq per batch was successfully conducted. All batches passed quality control according to European Pharmacopoeia standards. Therefore, we were able to disclose a new, simple and, at the same time, high yielding production pathway for the next generation PSMA radioligand [18F]PSMA-1007. Actually, it turned out that the radiosynthesis is as easily realised as the well-known [18F]FDG synthesis and, thus, transferable to all currently-available radiosynthesisers. Using the new procedures, the clinical daily routine can be sustainably supported in-house even in larger hospitals by a single production batch. |
| Databáze: | OpenAIRE |
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