Mélodie Ferrat, Mohammad M. Moein, Carmen Cananau, Tetyana Tegnebratt, Paul Saliba, Fredrik Norman, Carsten Steiger, Klas Bratteby, Erik Samén, Kenneth Dahl, Thuy A. Tran
{"title":"在 TRACERLab FX2 N 合成模块上用 GMP 生产[18F]FE-PE2I，这是一种用于多巴胺转运体内 PET 成像的放射性示踪剂","authors":"Mélodie Ferrat, Mohammad M. Moein, Carmen Cananau, Tetyana Tegnebratt, Paul Saliba, Fredrik Norman, Carsten Steiger, Klas Bratteby, Erik Samén, Kenneth Dahl, Thuy A. Tran","doi":"10.1186/s41181-024-00269-9","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Parkinson's disease is a neurodegenerative disorder that is characterized by a degeneration of the dopaminergic system. Dopamine transporter (DAT) positron emission tomography (PET) imaging has emerged as a powerful and non-invasive method to quantify dopaminergic function in the living brain. The PET radioligand, [<sup>18</sup>F]FE-PE2I, a cocaine chemical derivative, has shown promising properties for in vivo PET imaging of DAT, including high affinity and selectivity for DAT, excellent brain permeability, and favorable metabolism. The aim of the current study was to scale up the production of [<sup>18</sup>F]FE-PE2I to fulfil the increasing clinical demand for this tracer.</p><h3>Results</h3><p>Thus, a fully automated and GMP-compliant production procedure has been developed using a commercially available radiosynthesis module GE TRACERLab FX2 N. [<sup>18</sup>F]FE-PE2I was produced with a radiochemical yield of 39 ± 8% (n = 4, relative [<sup>18</sup>F]F<sup>−</sup> delivered to the module). The synthesis time was 70 min, and the molar activity was 925.3 ± 763 GBq/µmol (250 ± 20 Ci/µmol). The produced [<sup>18</sup>F]FE-PE2I was stable over 6 h at room temperature.</p><h3>Conclusion</h3><p>The protocol reliably provides a sterile and pyrogen–free GMP-compliant product.</p></div>","PeriodicalId":534,"journal":{"name":"EJNMMI Radiopharmacy and Chemistry","volume":"9 1","pages":""},"PeriodicalIF":4.4000,"publicationDate":"2024-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ejnmmipharmchem.springeropen.com/counter/pdf/10.1186/s41181-024-00269-9","citationCount":"0","resultStr":"{\"title\":\"GMP production of [18F]FE-PE2I on a TRACERLab FX2 N synthesis module, a radiotracer for in vivo PET imaging of the dopamine transport\",\"authors\":\"Mélodie Ferrat, Mohammad M. Moein, Carmen Cananau, Tetyana Tegnebratt, Paul Saliba, Fredrik Norman, Carsten Steiger, Klas Bratteby, Erik Samén, Kenneth Dahl, Thuy A. Tran\",\"doi\":\"10.1186/s41181-024-00269-9\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Parkinson's disease is a neurodegenerative disorder that is characterized by a degeneration of the dopaminergic system. Dopamine transporter (DAT) positron emission tomography (PET) imaging has emerged as a powerful and non-invasive method to quantify dopaminergic function in the living brain. The PET radioligand, [<sup>18</sup>F]FE-PE2I, a cocaine chemical derivative, has shown promising properties for in vivo PET imaging of DAT, including high affinity and selectivity for DAT, excellent brain permeability, and favorable metabolism. The aim of the current study was to scale up the production of [<sup>18</sup>F]FE-PE2I to fulfil the increasing clinical demand for this tracer.</p><h3>Results</h3><p>Thus, a fully automated and GMP-compliant production procedure has been developed using a commercially available radiosynthesis module GE TRACERLab FX2 N. [<sup>18</sup>F]FE-PE2I was produced with a radiochemical yield of 39 ± 8% (n = 4, relative [<sup>18</sup>F]F<sup>−</sup> delivered to the module). The synthesis time was 70 min, and the molar activity was 925.3 ± 763 GBq/µmol (250 ± 20 Ci/µmol). The produced [<sup>18</sup>F]FE-PE2I was stable over 6 h at room temperature.</p><h3>Conclusion</h3><p>The protocol reliably provides a sterile and pyrogen–free GMP-compliant product.</p></div>\",\"PeriodicalId\":534,\"journal\":{\"name\":\"EJNMMI Radiopharmacy and Chemistry\",\"volume\":\"9 1\",\"pages\":\"\"},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2024-05-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ejnmmipharmchem.springeropen.com/counter/pdf/10.1186/s41181-024-00269-9\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"EJNMMI Radiopharmacy and Chemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://link.springer.com/article/10.1186/s41181-024-00269-9\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, INORGANIC & NUCLEAR\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"EJNMMI Radiopharmacy and Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://link.springer.com/article/10.1186/s41181-024-00269-9","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, INORGANIC & NUCLEAR","Score":null,"Total":0}
GMP production of [18F]FE-PE2I on a TRACERLab FX2 N synthesis module, a radiotracer for in vivo PET imaging of the dopamine transport
Background
Parkinson's disease is a neurodegenerative disorder that is characterized by a degeneration of the dopaminergic system. Dopamine transporter (DAT) positron emission tomography (PET) imaging has emerged as a powerful and non-invasive method to quantify dopaminergic function in the living brain. The PET radioligand, [18F]FE-PE2I, a cocaine chemical derivative, has shown promising properties for in vivo PET imaging of DAT, including high affinity and selectivity for DAT, excellent brain permeability, and favorable metabolism. The aim of the current study was to scale up the production of [18F]FE-PE2I to fulfil the increasing clinical demand for this tracer.
Results
Thus, a fully automated and GMP-compliant production procedure has been developed using a commercially available radiosynthesis module GE TRACERLab FX2 N. [18F]FE-PE2I was produced with a radiochemical yield of 39 ± 8% (n = 4, relative [18F]F− delivered to the module). The synthesis time was 70 min, and the molar activity was 925.3 ± 763 GBq/µmol (250 ± 20 Ci/µmol). The produced [18F]FE-PE2I was stable over 6 h at room temperature.
Conclusion
The protocol reliably provides a sterile and pyrogen–free GMP-compliant product.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
