Preprint Article Version 1 This version is not peer-reviewed

Procedures for the GMP-Compliant Production and Quality Control of [18F]PSMA-1007—A Next Generation Radiofluorinated Tracer for the Detection of Prostate Cancer

Version 1 : Received: 15 August 2017 / Approved: 17 August 2017 / Online: 17 August 2017 (06:10:57 CEST)

A peer-reviewed article of this Preprint also exists.

Cardinale, J.; Martin, R.; Remde, Y.; Schäfer, M.; Hienzsch, A.; Hübner, S.; Zerges, A.-M.; Marx, H.; Hesse, R.; Weber, K.; Smits, R.; Hoepping, A.; Müller, M.; Neels, O.C.; Kopka, K. Procedures for the GMP-Compliant Production and Quality Control of [18F]PSMA-1007: A Next Generation Radiofluorinated Tracer for the Detection of Prostate Cancer. Pharmaceuticals 2017, 10, 77. Cardinale, J.; Martin, R.; Remde, Y.; Schäfer, M.; Hienzsch, A.; Hübner, S.; Zerges, A.-M.; Marx, H.; Hesse, R.; Weber, K.; Smits, R.; Hoepping, A.; Müller, M.; Neels, O.C.; Kopka, K. Procedures for the GMP-Compliant Production and Quality Control of [18F]PSMA-1007: A Next Generation Radiofluorinated Tracer for the Detection of Prostate Cancer. Pharmaceuticals 2017, 10, 77.

Journal reference: Pharmaceuticals 2017, 10, 77
DOI: 10.3390/ph10040077

Abstract

Radiolabelled 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 next generation radiofluorinated Glu-ureido PSMA inhibitor after [18F]DCFPyL and [18F]DCFBC. Since radiosynthesis so far was suffering for 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 30-70 % and synthesis times less than 55 minutes. 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 onto all currently available radiosynthesisers. Using the new procedures, clinical daily routine can be sustainably supported in-house even in larger hospitals by a single production batch.

Subject Areas

[18F]PSMA-1007; fluorine-18; PSMA; automation; prostate cancer; PET

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