Abstract
The production of [18F]Fluorodeoxyglucose ([18F]FDG) using a GE FASTLab2 synthesizer enables to obtain higher radiochemical yields including more robust synthesis process. This work evaluates the performance of GE FASTlab2 and discusses further the regulatory aspects of upgrading a synthesizer. The analytical results after end of synthesis (EOS) demonstrate the superiority of the GE FASTlab2 (71.3% ± 6.7) versus GE Tracerlab MX FDG (57.7% ± 4.2). The FDG Duo performance showed high radiochemical yields after EOS with 72.5% ± 1.5 and 72.9% ± 2.0 for the first and second run. The radiochemical purity for the GE FASTlab2 synthesizer amounted to 99.78% ± 0.1. No radiolabeled intermediate compound (FTAG) was present in the final product solution. These good results were obtained by different FASTlab2 cassette modifications and the synthesis steps involved. Thus a higher amount of precursor, an improved FTAG trapping method, the use of tC18 long plus cartridge, novel FASTlab2 cassette valve design, and nitrogen gas flushing of final tubing was applied. Additionally, this work deals with regulatory aspects which had to be fulfilled during the upgrading process.
Similar content being viewed by others
References
Petroni D, Menichetti L, Poli M (2020) Historical and radiopharmaceutical relevance of [18F]FDG. J Radioanal Nuclear Chem 323(3):1017–1031
Ashhar Z et al (2020) Preparation, characterization, and radiolabeling of [68Ga]Ga-NODAGA-Pamidronic acid: a potential PET bone imaging agent. Molecules 25(11):2668
Heidari P et al (2016) Design, construction and testing of a low-cost automated (68)Gallium-labeling synthesis unit for clinical use, (in eng). Am J Nucl Med Mol Imaging 6(3):176–184
Muhammad FAF, Abdul HSS, Mohd JSN, Azahari K, Fahlawi WSA (2016) A survey on the usage and demand of medical radioisotope and radiopharmaceuticals in Malaysia. J Sains Nuklear Malaysia 28(2):37–53
Boschi S, Malizia C, Lodi F (2013) Overview and perspectives on automation strategies in (68)Ga radiopharmaceutical preparations, (in eng). Recent Results Cancer Res 194:17–31
Shih IH et al (2014) Automated synthesis of 18F-fluoropropoxytryptophan for amino acid transporter system imaging," (in eng). Biomed Res Int 2014:492545
Sowa AR et al (2018) Futureproofing [(18)F]Fludeoxyglucose manufacture at an academic medical center, (in eng). EJNMMI Radiopharm Chem 3:12
Lemaire C et al (2002) Fast [18F]FDG synthesis by alkaline hydrolysis on a low polarity solid phase support. J Labell Compd Radiopharmaceut Off J Int Isotope Soc 45(5):435–447
Gomzina NA, Vasil’ev DA, Krasikova RN (2002) Optimization of automated synthesis of 2-[18F]Fluoro-2-deoxy-D-glucose involving base hydrolysis. Radiochemistry 44(4):403–409
Guo X, Kristal BS (2012) The use of underloaded C(18) solid-phase extraction plates increases reproducibility of analysis of tryptic peptides from unfractionated human plasma, (in eng). Anal Biochem 426(1):86–90
Hung JC (2002) Comparison of various requirements of the quality assurance procedures for (18)F-FDG injection, (in eng). J Nucl Med 43(11):1495–1506
Yu S (2006) Review of F-FDG synthesis and quality control, (in eng). Biomed Imaging Intervention J 2(4):e57–e57
Jacobson MS, Dankwart HR, Mahoney DW (2009) Radiolysis of 2-[18F]fluoro-2-deoxy-D-glucose ([18F]FDG) and the role of ethanol and radioactive concentration, (in eng). Appl Radiat Isot 67(6):990–995
Walters LR, Martin KJ, Jacobson MS, Hung JC, Mosman EA (2012) Stability evaluation of (18)F-FDG at high radioactive concentrations, (in eng). J Nucl Med Technol 40(1):52–56
Blackburn TD (2004) A practical approach to commissioning and qualification - a symbiotic relationship. Pharm Eng 24(4):10
Acknowledgements
The authors thank the Pharmacy Practice and Development Division, Pharmaceutical Services Programme, Ministry of Health Malaysia, and the Head of Nuclear Medicine Department, Institut Kanser Negara Putrajaya, for the keen support for this upgrading project. This study has been approved by the Medical Research and Ethics Committee (MREC), Ministry of Health Malaysia, with a reference number NMRR-21-273-58921. We would also like to thank the Director-General of Health Malaysia for his permission to publish this article.
Author information
Authors and Affiliations
Contributions
Conceptualization; Original draft preparation [MFAF]. Methodology; Formal analysis and investigation; Review and editing [ZA]. Review and editing; Supervision [ZMS].
Corresponding author
Ethics declarations
Conflict of interest
All authors declare no conflict of interest financially or otherwise.
Additional information
Publisher's Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
About this article
Cite this article
Fadzil, M.F.A., Ashhar, Z. & Safee, Z.M. Upgrades and regulatory aspects of [18F]Fluorodeoxyglucose ([18F]FDG) production using the FASTLab2 synthesizer. J Radioanal Nucl Chem 331, 99–110 (2022). https://doi.org/10.1007/s10967-021-08065-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s10967-021-08065-4