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10:33
An Automated Radiosynthesis of [68Ga]Ga-FAPI-46 for Routine Clinical Use
Published on: May 24, 2024
814
从使用液体目标的旋转机中完全自动生产[68 Ga]GaFAPI-46与-68
Alexandra I Fonseca1, Vítor H Alves1,2, Ivanna Hrynchak1
1ICNAS Pharma, University of Coimbra, 3004-531 Coimbra, Portugal.
International journal of molecular sciences
|October 28, 2023
概括
循环天文仪产生的-68可提高Ga-68 FAPI-46的产量,用于PET成像. 这种方法比发电机产生更高的活性,满足有效瘤检测的临床需求.
科学领域:
- 核医学就是核医学.
- 放射性药物化学 放射性药物化学
- 定子发射断层扫描 (PET) 成像成像
背景情况:
- 基于-68 (68Ga) 的放射性药物对PET瘤成像至关重要.
- 目前对68Ge/68Ga发电机的依赖限制了活动生产.
- 68Ga的旋转子生产提供了一个可扩展的替代方案.
研究的目的:
- 为了优化[68Ga]GaFAPI-46.的良好制造实践 (GMP) 生产.
- 为了利用通过有液体目标的医疗旋转器产生的68Ga.
- 为验证临床使用的合成和分析方法.
主要方法:
- 使用IBA Synthera®扩展模块优化了[68Ga]GaFAPI-46的GMP合成.
- 通过使用液体目标的医疗循环仪产生68Ga.
- 根据Ph. 博士的质量控制的验证分析方法. 欧元. 欧元. 在欧元. 标准. 标准. 标准. 标准.
主要成果:
- 成功生产具有高放射性化学纯度 (>98.94%) 和产量的[68Ga]GaFAPI-46.
- 在EOP时,循环生产的68Ga产生了4.31 ± 0.36 GBq.
- 经验证的GMP批量在EOS生产了2.50 ± 0.46 GBq,质量维持了3小时.
结论:
- 使用循环仪生产的68Ga可行生产[68Ga]GaFAPI-46的验证的GMP生产.
- 与发电机相比,这种方法显著增加了活性,解决了临床需求.
- 已建立的质量控制确保适合常规的临床PET成像.
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