Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application
Abstract Background Sodium 18F-fluoride for injection can be easily cyclotron-produced and purified, as a simple inorganic salt, by adsorption/desorption onto an anion-exchange cartridge and then dispensed for clinical use. Since the clinical demand for this radiopharmaceutical is constantly increas...
Saved in:
| Main Authors: | , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
SpringerOpen
2025-02-01
|
| Series: | EJNMMI Radiopharmacy and Chemistry |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s41181-025-00329-8 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1823861488693018624 |
|---|---|
| author | Marija Atanasova Lazareva Maja Chochevska Katerina Kolevska Maja Velickovska Filip Jolevski Paulina Apostolova Ana Ugrinska Emilija Janevik-Ivanovska |
| author_facet | Marija Atanasova Lazareva Maja Chochevska Katerina Kolevska Maja Velickovska Filip Jolevski Paulina Apostolova Ana Ugrinska Emilija Janevik-Ivanovska |
| author_sort | Marija Atanasova Lazareva |
| collection | DOAJ |
| description | Abstract Background Sodium 18F-fluoride for injection can be easily cyclotron-produced and purified, as a simple inorganic salt, by adsorption/desorption onto an anion-exchange cartridge and then dispensed for clinical use. Since the clinical demand for this radiopharmaceutical is constantly increasing, this study aimed to design and develop a simple, fully automated method for the in-house, rapid, and efficient processing and dispensing of injectable solutions of Sodium 18F-fluoride without the need of a synthesis module and disposable kit, but using only the dispensing unit. Results A new simple method for the efficient routine production of injectable solutions of [18F]NaF was developed through a straightforward modification of the commercial dispenser Clio (Comecer S.p.A., Italy) and without the need of a synthesis module. The full production, processing and dispensing of [18F]NaF were entirely carried out on the same batch using only the dispensing module. Process validation was carried according to GMP guidelines to ensure consistency of [18F]NaF quality with international standards. The final radiopharmaceutical met all quality criteria specified by Ph. Eur. and chemical, radionuclidic and radiochemical impurities were significantly below the required limits. Conclusion A new simple and reliable procedure developed for the preparation and dispensing of injectable [18F]NaF in less than 10 min with a radiochemical yield > 97% (decay corrected) has been successfully developed. Notably, the proposed method also allows the preparation of [18F]NaF using the residual fluorine-18 activity remaining after a [18F]FDG production run, thus making it immediately accessible to patients for further PET imaging investigations. |
| format | Article |
| id | doaj-art-a3e791e42a2142debecfbff9cd89143b |
| institution | Kabale University |
| issn | 2365-421X |
| language | English |
| publishDate | 2025-02-01 |
| publisher | SpringerOpen |
| record_format | Article |
| series | EJNMMI Radiopharmacy and Chemistry |
| spelling | doaj-art-a3e791e42a2142debecfbff9cd89143b2025-02-09T13:00:40ZengSpringerOpenEJNMMI Radiopharmacy and Chemistry2365-421X2025-02-0110111110.1186/s41181-025-00329-8Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical applicationMarija Atanasova Lazareva0Maja Chochevska1Katerina Kolevska2Maja Velickovska3Filip Jolevski4Paulina Apostolova5Ana Ugrinska6Emilija Janevik-Ivanovska7University Institute of Positron Emission TomographyUniversity Institute of Positron Emission TomographyUniversity Institute of Positron Emission TomographyUniversity Institute of Positron Emission TomographyUniversity Institute of Positron Emission TomographyFaculty of Medical Sciences, Goce Delcev UniversityFaculty of Medicine, Ss. Cyril and Methodius UniversityFaculty of Medical Sciences, Goce Delcev UniversityAbstract Background Sodium 18F-fluoride for injection can be easily cyclotron-produced and purified, as a simple inorganic salt, by adsorption/desorption onto an anion-exchange cartridge and then dispensed for clinical use. Since the clinical demand for this radiopharmaceutical is constantly increasing, this study aimed to design and develop a simple, fully automated method for the in-house, rapid, and efficient processing and dispensing of injectable solutions of Sodium 18F-fluoride without the need of a synthesis module and disposable kit, but using only the dispensing unit. Results A new simple method for the efficient routine production of injectable solutions of [18F]NaF was developed through a straightforward modification of the commercial dispenser Clio (Comecer S.p.A., Italy) and without the need of a synthesis module. The full production, processing and dispensing of [18F]NaF were entirely carried out on the same batch using only the dispensing module. Process validation was carried according to GMP guidelines to ensure consistency of [18F]NaF quality with international standards. The final radiopharmaceutical met all quality criteria specified by Ph. Eur. and chemical, radionuclidic and radiochemical impurities were significantly below the required limits. Conclusion A new simple and reliable procedure developed for the preparation and dispensing of injectable [18F]NaF in less than 10 min with a radiochemical yield > 97% (decay corrected) has been successfully developed. Notably, the proposed method also allows the preparation of [18F]NaF using the residual fluorine-18 activity remaining after a [18F]FDG production run, thus making it immediately accessible to patients for further PET imaging investigations.https://doi.org/10.1186/s41181-025-00329-8In-house production[18F]NaFCost-effective methodResidual activityValidation |
| spellingShingle | Marija Atanasova Lazareva Maja Chochevska Katerina Kolevska Maja Velickovska Filip Jolevski Paulina Apostolova Ana Ugrinska Emilija Janevik-Ivanovska Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application EJNMMI Radiopharmacy and Chemistry In-house production [18F]NaF Cost-effective method Residual activity Validation |
| title | Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application |
| title_full | Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application |
| title_fullStr | Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application |
| title_full_unstemmed | Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application |
| title_short | Development of an automated method for in-house production of sodium 18F-fluoride for injection: process validation as a step toward routine clinical application |
| title_sort | development of an automated method for in house production of sodium 18f fluoride for injection process validation as a step toward routine clinical application |
| topic | In-house production [18F]NaF Cost-effective method Residual activity Validation |
| url | https://doi.org/10.1186/s41181-025-00329-8 |
| work_keys_str_mv | AT marijaatanasovalazareva developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT majachochevska developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT katerinakolevska developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT majavelickovska developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT filipjolevski developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT paulinaapostolova developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT anaugrinska developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication AT emilijajanevikivanovska developmentofanautomatedmethodforinhouseproductionofsodium18ffluorideforinjectionprocessvalidationasasteptowardroutineclinicalapplication |