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Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center
BACKGROUND: We recently upgraded our [(18)F]fludeoxyglucose (FDG) production capabilities with the goal of futureproofing our FDG clinical supply, expanding the number of batches of FDG we can manufacture each day, and improving patient throughput in our nuclear medicine clinic. In this paper we rep...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173674/ https://www.ncbi.nlm.nih.gov/pubmed/30363401 http://dx.doi.org/10.1186/s41181-018-0048-x |
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author | Sowa, Alexandra R Jackson, Isaac M Desmond, Timothy J Alicea, Jeremiah Mufarreh, Anthony J Pham, Jonathan M Stauff, Jenelle Winton, Wade P Fawaz, Maria V Henderson, Bradford D Hockley, Brian G Rogers, Virginia E Koeppe, Robert A Scott, Peter J H |
author_facet | Sowa, Alexandra R Jackson, Isaac M Desmond, Timothy J Alicea, Jeremiah Mufarreh, Anthony J Pham, Jonathan M Stauff, Jenelle Winton, Wade P Fawaz, Maria V Henderson, Bradford D Hockley, Brian G Rogers, Virginia E Koeppe, Robert A Scott, Peter J H |
author_sort | Sowa, Alexandra R |
collection | PubMed |
description | BACKGROUND: We recently upgraded our [(18)F]fludeoxyglucose (FDG) production capabilities with the goal of futureproofing our FDG clinical supply, expanding the number of batches of FDG we can manufacture each day, and improving patient throughput in our nuclear medicine clinic. In this paper we report upgrade of the synthesis modules to the GE FASTLab 2 platform (Phase 1) and cyclotron updates (Phase 2) from both practical and regulatory perspectives. We summarize our experience manufacturing FDG on the FASTLab 2 module with a high-yielding self-shielded niobium (Nb) fluorine-18 target. RESULTS: Following installation of Nb targets for production of fluorine-18, a 55 μA beam for 22 min generated 1330 ± 153 mCi of [(18)F]fluoride. Using these cyclotron beam parameters in combination with the FASTLab 2, activity yields (AY) of FDG were 957 ± 102 mCi at EOS, corresponding to 72% non-corrected AY (n = 235). Our workflow, inventory management and regulatory compliance have been greatly simplified following the synthesis module and cyclotron upgrades, and patient wait times for FDG PET have been cut in half at our nuclear medicine clinic. CONCLUSIONS: The combination of FASTlab 2 and self-shielded Nb fluorine-18 targets have improved our yield of FDG, and enabled reliable and repeatable manufacture of the radiotracer for clinical use. |
format | Online Article Text |
id | pubmed-6173674 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-61736742018-10-22 Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center Sowa, Alexandra R Jackson, Isaac M Desmond, Timothy J Alicea, Jeremiah Mufarreh, Anthony J Pham, Jonathan M Stauff, Jenelle Winton, Wade P Fawaz, Maria V Henderson, Bradford D Hockley, Brian G Rogers, Virginia E Koeppe, Robert A Scott, Peter J H EJNMMI Radiopharm Chem Methodology BACKGROUND: We recently upgraded our [(18)F]fludeoxyglucose (FDG) production capabilities with the goal of futureproofing our FDG clinical supply, expanding the number of batches of FDG we can manufacture each day, and improving patient throughput in our nuclear medicine clinic. In this paper we report upgrade of the synthesis modules to the GE FASTLab 2 platform (Phase 1) and cyclotron updates (Phase 2) from both practical and regulatory perspectives. We summarize our experience manufacturing FDG on the FASTLab 2 module with a high-yielding self-shielded niobium (Nb) fluorine-18 target. RESULTS: Following installation of Nb targets for production of fluorine-18, a 55 μA beam for 22 min generated 1330 ± 153 mCi of [(18)F]fluoride. Using these cyclotron beam parameters in combination with the FASTLab 2, activity yields (AY) of FDG were 957 ± 102 mCi at EOS, corresponding to 72% non-corrected AY (n = 235). Our workflow, inventory management and regulatory compliance have been greatly simplified following the synthesis module and cyclotron upgrades, and patient wait times for FDG PET have been cut in half at our nuclear medicine clinic. CONCLUSIONS: The combination of FASTlab 2 and self-shielded Nb fluorine-18 targets have improved our yield of FDG, and enabled reliable and repeatable manufacture of the radiotracer for clinical use. Springer International Publishing 2018-10-05 /pmc/articles/PMC6173674/ /pubmed/30363401 http://dx.doi.org/10.1186/s41181-018-0048-x Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Methodology Sowa, Alexandra R Jackson, Isaac M Desmond, Timothy J Alicea, Jeremiah Mufarreh, Anthony J Pham, Jonathan M Stauff, Jenelle Winton, Wade P Fawaz, Maria V Henderson, Bradford D Hockley, Brian G Rogers, Virginia E Koeppe, Robert A Scott, Peter J H Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center |
title | Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center |
title_full | Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center |
title_fullStr | Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center |
title_full_unstemmed | Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center |
title_short | Futureproofing [(18)F]Fludeoxyglucose manufacture at an Academic Medical Center |
title_sort | futureproofing [(18)f]fludeoxyglucose manufacture at an academic medical center |
topic | Methodology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6173674/ https://www.ncbi.nlm.nih.gov/pubmed/30363401 http://dx.doi.org/10.1186/s41181-018-0048-x |
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