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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...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2018
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.
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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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