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The Development of Radiopharmaceutical Synthesizer and its FDG Synthesis Verification

  • Received : 2022.12.01
  • Accepted : 2022.12.14
  • Published : 2022.12.30

Abstract

[18F]FDG is known as the most widely used radiopharmaceutical in the imaging field of nuclear medicine worldwide. With the introduction of PET equipment, the demand for [18F]FDG has increased and the production volume has also increased. However, in order to increase production, the use of 18F radioisotope must be increased or [18F]FDG must be synthesized in high yield. Therefore, in order to meet the high yield and purity of radiopharmaceuticals, a radiopharmaceutical automatic synthesizer was required. As the use of [18F]FDG increased, automated synthesizer manufacturers supplied various types of radiopharmaceutical automated synthesizers to the market. In this study, we developed a commercialized [18F]FDG radiopharmaceutical automatic synthesizer (sCUBE FDG) using a disposable cassette type that complies with GMP developed by FutureChem, a leading radiopharmaceutical company. We used sCUBE FDG to verify the production process, radiopharmaceutical's quality (radiochemical purity, etc.), and radiochemical yield of [18F]FDG. As a result of optimizing the automatic synthesis process and synthesizing a total of 30 times, the production time was 35 ± 3 minutes and the average production yield was 65.6%.

Keywords

Acknowledgement

The 18F radioisotope used in this study was supported by the FutureChem Cyclotron Center, Ewha Womans University Medical Center (EUMC), Republic of Korea

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