FEATURES OF PRODUCING THE RADIOPHARMACEUTICAL DRUG “FLUORODEOXYGLUCOSE ¹⁸F” USING A LOW-POWER CYCLOTRON: EXPERIENCE AND PERSPECTIVES

The study presents a comparative analysis of pharmacy-based and industrial production of the radiopharmaceutical 2-[¹⁸F]fluoro-2-deoxy-D-glucose (¹⁸F-FDG). The study compares the infrastructure, synthesis process, purification and dispensing systems, as well as quality control procedures, including radionuclidic and radiochemical purity, residual solvents, bacterial endotoxins, pH and sterility. The study demonstrates that small-scale pharmacy production based on a compact cyclotron complex with cassette synthesis modules provides product quality comparable to centralized industrial production on a high-energy cyclotron with an extended analytical infrastructure. The pharmacy model allows implementation of a “dose-on-demand” principle, reducing activity losses and ensuring flexible supply for patients of a specific center. The industrial model provides high throughput and centralized supply for a network of PET centers. The results emphasize that both organizational models are capable of maintaining high quality and safety standards for ¹⁸F-FDG, while the choice of an appropriate production scheme depends on the size of the center, patient flow, and regional logistic conditions.

1. Malygin D. S., Khayretdinov A. Kh., Shevyakov I. S. Razvitie yadernoy meditsiny v XXI veke // Yadernye tekhnologii: ot issledovaniy k vnedreniyu. – 2021. – P. 123-124. (In Russ)

2. Bekman I. N. Radiatsionnaya i yadernaya meditsina: fizicheskie i khimicheskie aspekty // Radiokhimiya. – 2012. – T. 7. – P. 400. (In Russ)

3. Kodina G. E., Vlasova O. P., Tishchenko V. K., Dorovatovskiy S. A., Ryzhikova T. P., Ivanov S. A., Shegay P. V., Kaprin A. D., Trapkova A. A. Regulyatornye trebovaniya k aptechnomu izgotovleniyu radiofarmatsevticheskikh lekarstvennykh preparatov // Regulyatornye issledovaniya i ekspertiza lekarstvennykh sredstv. – 2025. – T. 15, № 4. – P. 404–420. (In Russ)

4. Gurin A. N., Chakrova E. T., Medvedeva Z. V., Soloninkina S. G. Perspektivy razvitiya yadernoy meditsiny v Respublike Kazakhstan: reaktornye izotopy redkozemel’nykh elementov dlya terapii // Vestnik NYaTs RK. – 2022. – № 2. – P. 46-52. (In Russ)

5. Chernov V. I., Medvedeva A. A., Sinilkin I. G., Zel’chan R. V., Bragina O. D., Choynzonov E. L. Yadernaya meditsina v diagnostike i adresnoy terapii zlokachestvennykh novoobrazovaniy // Byulleten’ sibirskoy meditsiny. – 2018. – T. 17, № 1. – P. 220-231. (In Russ)

6. Yang H., Bai J., Li X., et al. Clinical Application of Positron Emission Tomography/Magnetic Resonance Imaging in Pelvic Malignant Tumors // iRADIOLOGY. – 2025. – Vol. 3, No. 6. – P. 421–433. https://doi.org/10.1002/ird3.70033

7. Nanni C., Farolfi A., Castellucci P., Fanti S. Total Body Positron Emission Tomography/Computed Tomography: Current Status in Oncology // Seminars in Nuclear Medicine. – 2025. – Vol. 55, No. 1. – P. 31-40. doi: 10.1053/j.semnuclmed.2024.10.006

8. Dolgushin M. B., Stilidi I. S. PET/KT v prakticheskoy onkologii. – M.: Izdatel’skiy dom Vidar, 2021. – 552 p. (In Russ)

9. Periodictable.com. Isotopes of Gadolinium (Gd) [Internet]. – Режим доступа: https://periodictable.com/Isotopes/064.158/index.full.prod.html

10. Remizov P.D., i dr. Sovremennye meditsinskie radionuklidy dlya immuno-PET // Meditsinskaya radiologiya i radiatsionnaya bezopasnost’. – 2022. – T. 67, № 3. – P. 67-74. (In Russ)

11. Климанов В. А. Радионуклидная диагностика: физические принципы и технологии. – М.: Интеллект, 2013. – 332 с. [Klimanov V. A. Radionuklidnaya diagnostika: fizicheskie printsipy i tekhnologii. – M.: Intellekt, 2013. – 332 p. (In Russ)

12. International Atomic Energy Agency. Cyclotron Produced Radionuclides: Principles and Practice. – Vienna: IAEA, 2008. – 465 p.

13. Kochengin A. E. Oborudovanie dlya sinteza radiofarmpreparatov // Vestnik Soveta molodykh uchenykh i spetsialistov Chelyabinskoy oblasti. – 2018. – T. 2, № 1. – P. 64-65. (In Russ)

14. Gosudarstvennaya farmakopeya Respubliki Kazakhstan. – Almaty: Zhibek zholy, 2008. – T. 1. – 592 p. (In Russ)

15. Gosudarstvennaya farmakopeya Respubliki Kazakhstan. – Almaty: Zhibek zholy, 2009. – T. 2. – 804 p. (In Russ)

16. International Atomic Energy Agency. Cyclotron Produced Radionuclides: Guidance on Facility Design and Production of [18F]FDG. – Vienna: IAEA, 2012.

17. Gillings N., Hjelstuen O., Ballinger J., Behe M., Decristoforo C., Elsinga P., Ferrari V., Peitl P. K., Koziorowski J., Laverman P., Mindt T. L., Neels O., Ocak M., Patt M., Todde S. Guideline on Current Good Radiopharmacy Practice (cGRPP) for the Small-Scale Preparation of Radiopharmaceuticals // EJNMMI Radiopharmacy and Chemistry. – 2021. – Vol. 6, No. 1. – P. 8. doi: 10.1186/s41181-021-00123-2