Eryilmaz Kurtulus, Kilbas Benan
Moltek A. S. Gebze Organize Sanayi, 41400 Gebze, Kocaeli, Turkey.
EJNMMI Radiopharm Chem. 2021 Apr 16;6(1):16. doi: 10.1186/s41181-021-00130-3.
To the best of our knowledge, manually production of [Lu]Lu-FAPI radiopharmaceutical derivatives has been only described in literature. In this work, a fully-automated [Lu]Lu-FAPI synthesis has been well designed for the first time using commercially available synthesis module. In addition to the development of an automated system with disposable cassette, quality control (QC) and stability studies were comprehensively presented.
A fully automated synthesis of [Lu]Lu-FAPI derivatives was achieved on the Modular Lab Eazy (ML Eazy) with high radiochemical yield ([Lu]Lu-FAPI-04; 88% ± 3, [Lu]Lu-FAPI-46; 86% ± 3). Chromatographic analysis indicated the formation of radiosynthesis with an absolute radiochemical purity (99%). Stability experiments clarified the durability of the products within 4 days. All obtained specifications are consistent to European Pharmacopoeia.
A fully automated synthesis of [Lu]Lu-FAPI radiopharmaceuticals was accomplished regarding quality control standards and quality assurance by using commercially available a modular approach namely ML Eazy with disposable customized cassette and template.
据我们所知，文献中仅描述了[镥]镥-FAPI放射性药物衍生物的手工生产。在本研究中，首次使用市售合成模块精心设计了一种全自动的[镥]镥-FAPI合成方法。除了开发带有一次性盒的自动化系统外，还全面介绍了质量控制（QC）和稳定性研究。
在模块化实验室Eazy（ML Eazy）上实现了[镥]镥-FAPI衍生物的全自动合成，放射性化学产率较高（[镥]镥-FAPI-04；88%±3，[镥]镥-FAPI-46；86%±3）。色谱分析表明放射性合成产物的绝对放射性化学纯度为99%。稳定性实验明确了产品在4天内的耐久性。所有获得的规格均符合欧洲药典。
通过使用市售的模块化方法，即带有一次性定制盒和模板的ML Eazy，在质量控制标准和质量保证方面完成了[镥]镥-FAPI放射性药物的全自动合成。
