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简化和高度可靠的FSPG自动生产用于临床研究
Mai Lin1, Robert T Ta2, H Charles Manning3,4
1Cyclotron Radiochemistry Facility, The University of Texas MD Anderson Cancer Center, Houston, TX, 77054, USA.
EJNMMI radiopharmacy and chemistry
|July 24, 2023
概括
现在可以自动生产 (S) - 4 - 3 - 18F - 基) - L - 胺酸 ([18F]FSPG) 用于临床使用. 这种PET追踪器对癌症和神经障碍成像具有前途,优化的合成产生高纯度和效率.
科学领域:
- 核医学和放射性药物化学.
- 发展正电子发射断层扫描 (PET) 标记器.
背景情况:
- (S) -4 - 3-18F-烯) -L-胺酸 ([18F]FSPG) 是一种针对囊/胺酸反载体 (xc-) 的PET标记物.
- xc-在癌症和神经系统疾病中过度表达,使[18F]FSPG成为潜在的诊断剂.
- 之前的研究表明,用[18F]FSPG PET显示出有希望的剂量测量,生物分布和瘤检测,由于背景吸收低,显示出出色的成像对比度.
研究的目的:
- 为[18F]FSPG合成建立可靠,生产规模,符合cGMP的自动化程序.
- 为了提高临床效用,使[18F]FSPG的集中和大规模生产成为可能.
主要方法:
- 使用两个商用平台优化[18F]FSPG的自动放射合成:TRACERlabTM FXFN和FASTlabTM.
- 评估放射性化学产量,纯度和稳定性.
- 最终配方产品的无菌性和pH测试.
主要成果:
- [18F]FSPG的全自动合成在从60-85 GBq开始活动后的45分钟内完成.
- 平均放射性化学产量为22.56 ± 0.97% (TRACERlabTM FXFN) 和30.82 ± 1.60% (FASTlabTM) (没有腐烂纠正).
- 放射性化学纯度超过95%,无菌,无色配方 (pH6.5-7.5) 并且在配方后8小时内没有观察到放射溶解.
结论:
- [18F]FSPG的符合cGMP的放射合成和质量控制已经在自动化平台上成功建立.
- 优化的自动化方法确保高活性度和放射化学纯度,支持临床使用.
- 这些自动化方法将加速临床采用,并促进中心化,大规模生产[18F]FSPG.
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