Fully Automated GMP-Compliant Synthesis of [ 18 F]FE-PE2I

In the struggle to understand and accurately diagnose Parkinson's disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shif...

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Published inPharmaceuticals (Basel, Switzerland) Vol. 14; no. 7; p. 601
Main Authors Bratteby, Klas, Denholt, Charlotte Lund, Lehel, Szabolcs, Petersen, Ida Nymann, Madsen, Jacob, Erlandsson, Maria, Ohlsson, Tomas, Herth, Matthias Manfred, Gillings, Nic
Format Journal Article
LanguageEnglish
Published Switzerland MDPI AG 22.06.2021
MDPI
Subjects
[18F]FE-PE2I
Automation
Ethanol
Experiments
Fluorides
fluorine-18
GMP
Good Manufacturing Practice
Radiation
radiochemistry
fluorine-18
[18F]FE-PE2I
automation
GMP
radiochemistry
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Abstract In the struggle to understand and accurately diagnose Parkinson's disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shift from the first generation of SPECT tracers, the fluorine-18-labeled tracer [ F]FE-PE2I has emerged as the agent of choice for many physicians. However, implementing suitable synthesis for the production of [ F]FE-PE2I has proved more challenging than expected. Through a thorough analysis of the relevant factors affecting the final radiochemical yield, we were able to implement high-yielding fully automated GMP-compliant synthesis of [ F]FE-PE2I on a Synthera + platform. By reaching RCYs up to 62%, it allowed us to isolate 25 GBq of the formulated product, and an optimized formulation resulted in the shelf life of 6 h, satisfying the increased demand for this radiopharmaceutical.
AbstractList In the struggle to understand and accurately diagnose Parkinson′s disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shift from the first generation of SPECT tracers, the fluorine-18-labeled tracer [18F]FE-PE2I has emerged as the agent of choice for many physicians. However, implementing suitable synthesis for the production of [18F]FE-PE2I has proved more challenging than expected. Through a thorough analysis of the relevant factors affecting the final radiochemical yield, we were able to implement high-yielding fully automated GMP-compliant synthesis of [18F]FE-PE2I on a Synthera®+ platform. By reaching RCYs up to 62%, it allowed us to isolate 25 GBq of the formulated product, and an optimized formulation resulted in the shelf life of 6 h, satisfying the increased demand for this radiopharmaceutical.
In the struggle to understand and accurately diagnose Parkinson′s disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shift from the first generation of SPECT tracers, the fluorine-18-labeled tracer [ 18 F]FE-PE2I has emerged as the agent of choice for many physicians. However, implementing suitable synthesis for the production of [ 18 F]FE-PE2I has proved more challenging than expected. Through a thorough analysis of the relevant factors affecting the final radiochemical yield, we were able to implement high-yielding fully automated GMP-compliant synthesis of [ 18 F]FE-PE2I on a Synthera ® + platform. By reaching RCYs up to 62%, it allowed us to isolate 25 GBq of the formulated product, and an optimized formulation resulted in the shelf life of 6 h, satisfying the increased demand for this radiopharmaceutical.
In the struggle to understand and accurately diagnose Parkinson's disease, radiopharmaceuticals and medical imaging techniques have played a major role. By being able to image and quantify the dopamine transporter density, noninvasive diagnostic imaging has become the gold standard. In the shift from the first generation of SPECT tracers, the fluorine-18-labeled tracer [ F]FE-PE2I has emerged as the agent of choice for many physicians. However, implementing suitable synthesis for the production of [ F]FE-PE2I has proved more challenging than expected. Through a thorough analysis of the relevant factors affecting the final radiochemical yield, we were able to implement high-yielding fully automated GMP-compliant synthesis of [ F]FE-PE2I on a Synthera + platform. By reaching RCYs up to 62%, it allowed us to isolate 25 GBq of the formulated product, and an optimized formulation resulted in the shelf life of 6 h, satisfying the increased demand for this radiopharmaceutical.
Author Erlandsson, Maria
Petersen, Ida Nymann
Madsen, Jacob
Ohlsson, Tomas
Lehel, Szabolcs
Gillings, Nic
Herth, Matthias Manfred
Bratteby, Klas
Denholt, Charlotte Lund
AuthorAffiliation 3 Department of Radiation Physics, Skåne University Hospital, Barngatan 3, 22242 Lund, Sweden; maria.n.erlandsson@skane.se (M.E.); tomas.ohlsson@skane.se (T.O.)
2 Department of Clinical Physiology Nuclear Medicine PET, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; charlotte.lund.denholt@regionh.dk (C.L.D.); szabolcs.lehel@regionh.dk (S.L.); ida.nymann.petersen@regionh.dk (I.N.P.); jacob.madsen@regionh.dk (J.M.)
1 Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100 Copenhagen, Denmark; klas.bratteby@sund.ku.dk (K.B.); matthias.herth@sund.ku.dk (M.M.H.)
AuthorAffiliation_xml – name: 1 Department of Drug Design and Pharmacology, University of Copenhagen, Jagtvej 160, 2100 Copenhagen, Denmark; klas.bratteby@sund.ku.dk (K.B.); matthias.herth@sund.ku.dk (M.M.H.)
– name: 2 Department of Clinical Physiology Nuclear Medicine PET, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, 2100 Copenhagen, Denmark; charlotte.lund.denholt@regionh.dk (C.L.D.); szabolcs.lehel@regionh.dk (S.L.); ida.nymann.petersen@regionh.dk (I.N.P.); jacob.madsen@regionh.dk (J.M.)
– name: 3 Department of Radiation Physics, Skåne University Hospital, Barngatan 3, 22242 Lund, Sweden; maria.n.erlandsson@skane.se (M.E.); tomas.ohlsson@skane.se (T.O.)
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Keywords fluorine-18
[18F]FE-PE2I
automation
GMP
radiochemistry
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Snippet In the struggle to understand and accurately diagnose Parkinson's disease, radiopharmaceuticals and medical imaging techniques have played a major role. By...
In the struggle to understand and accurately diagnose Parkinson′s disease, radiopharmaceuticals and medical imaging techniques have played a major role. By...
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SubjectTerms [18F]FE-PE2I
Automation
Ethanol
Experiments
Fluorides
fluorine-18
GMP
Good Manufacturing Practice
Radiation
radiochemistry
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Title Fully Automated GMP-Compliant Synthesis of [ 18 F]FE-PE2I
URI https://www.ncbi.nlm.nih.gov/pubmed/34206688
https://www.proquest.com/docview/2554765184
https://search.proquest.com/docview/2548397472
https://pubmed.ncbi.nlm.nih.gov/PMC8308591
https://doaj.org/article/9970e4c34953481b89c3e280c1ae8e6c
Volume 14
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