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Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application
BACKGROUND: [(68)Ga]Ga-FAPI-46 is a promising radiopharmaceutical for in vivo detection of the fibroblast activation protein by positron emission tomography. Until now, the synthesis of [(68)Ga]Ga-FAPI-46 has been only performed manually. Our aim was to evaluate the automated synthesis of this radio...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7746794/ https://www.ncbi.nlm.nih.gov/pubmed/33331982 http://dx.doi.org/10.1186/s41181-020-00112-x |
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author | Spreckelmeyer, Sarah Balzer, Matthias Poetzsch, Simon Brenner, Winfried |
author_facet | Spreckelmeyer, Sarah Balzer, Matthias Poetzsch, Simon Brenner, Winfried |
author_sort | Spreckelmeyer, Sarah |
collection | PubMed |
description | BACKGROUND: [(68)Ga]Ga-FAPI-46 is a promising radiopharmaceutical for in vivo detection of the fibroblast activation protein by positron emission tomography. Until now, the synthesis of [(68)Ga]Ga-FAPI-46 has been only performed manually. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on two different commercially available synthesis modules in order to make the tracer readily available for clinical application. RESULTS: The synthesis of [(68)Ga]Ga-FAPI-46 with different amounts of precursor (10–50 μg) on the Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy) from Eckert & Ziegler with a customized synthesis template and a customized single-use cassette yielded best results with 50 μg FAPI-46 for clinical multi-dose application. All relevant quality control parameters tested (e.g. sterility, stability and radiochemical purity) were in accordance with the European Pharmacopoeia. CONCLUSIONS: [(68)Ga]Ga-FAPI-46 was successfully synthesized fully-automated on the synthesis modules Modular Lab PharmTracer and ML eazy and is, thus, available for multi-dose application in clinical settings. |
format | Online Article Text |
id | pubmed-7746794 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-77467942020-12-28 Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application Spreckelmeyer, Sarah Balzer, Matthias Poetzsch, Simon Brenner, Winfried EJNMMI Radiopharm Chem Research Article BACKGROUND: [(68)Ga]Ga-FAPI-46 is a promising radiopharmaceutical for in vivo detection of the fibroblast activation protein by positron emission tomography. Until now, the synthesis of [(68)Ga]Ga-FAPI-46 has been only performed manually. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on two different commercially available synthesis modules in order to make the tracer readily available for clinical application. RESULTS: The synthesis of [(68)Ga]Ga-FAPI-46 with different amounts of precursor (10–50 μg) on the Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy) from Eckert & Ziegler with a customized synthesis template and a customized single-use cassette yielded best results with 50 μg FAPI-46 for clinical multi-dose application. All relevant quality control parameters tested (e.g. sterility, stability and radiochemical purity) were in accordance with the European Pharmacopoeia. CONCLUSIONS: [(68)Ga]Ga-FAPI-46 was successfully synthesized fully-automated on the synthesis modules Modular Lab PharmTracer and ML eazy and is, thus, available for multi-dose application in clinical settings. Springer International Publishing 2020-12-17 /pmc/articles/PMC7746794/ /pubmed/33331982 http://dx.doi.org/10.1186/s41181-020-00112-x Text en © The Author(s) 2020 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . |
spellingShingle | Research Article Spreckelmeyer, Sarah Balzer, Matthias Poetzsch, Simon Brenner, Winfried Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application |
title | Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application |
title_full | Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application |
title_fullStr | Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application |
title_full_unstemmed | Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application |
title_short | Fully-automated production of [(68)Ga]Ga-FAPI-46 for clinical application |
title_sort | fully-automated production of [(68)ga]ga-fapi-46 for clinical application |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7746794/ https://www.ncbi.nlm.nih.gov/pubmed/33331982 http://dx.doi.org/10.1186/s41181-020-00112-x |
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