We report herein an efficient and fully automated protocol for the radiosynthesis of [¹⁸F]FAPI-74, a new positron emission tomography (PET) radiopharmaceutical for in vivo detection of the fibroblast activation protein. [¹⁸F]FAPI-74 was synthesized via a rapid [¹⁸F]aluminum fluoride coordination reaction, which was first developed on the flexible GE TRACERLab FX2N (FXN) platform and later translated to the cassette-based module Trasis AllInOne (AIO). The results obtained with both modules were comparable in terms of yield and reproducibility. Automation of [¹⁸F]FAPI-74 radiosynthesis on the FXN was carried out in 35 min with a radiochemical yield (RCY) of 18.5 ± 2.5% (n = 5, relative to starting [¹⁸F]fluoride). Method transfer to the AIO platform following minor optimizations allowed for the production of [¹⁸F]FAPI-74 in an isolated RCY of 20 ± 2.5% [n = 3] with an overall synthesis time of 40 min. The radiochemical purity was greater than 95% for [¹⁸F]FAPI-74, obtained from both modules. Overall, the protocol reliably provides a sterile and pyrogen-free good manufacturing practice (GMP) compliant product of [¹⁸F]FAPI-74 suitable for clinical PET imaging.

中文翻译：

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成纤维细胞活化蛋白放射性示踪剂[18F]FAPI-74的全自动生产

^{我们在此报告了一种用于放射合成 [ 18} F]FAPI-74的有效且完全自动化的方案，这是一种用于体内检测成纤维细胞活化蛋白的新型正电子发射断层扫描 (PET) 放射性药物。[ ¹⁸ F]FAPI-74 是通过快速的 [ ¹⁸ F] 氟化铝配位反应合成的，该反应首先在灵活的 GE TRACERLab FX2N (FXN) 平台上开发，后来被转化为基于卡带的模块 Trasis AllInOne (AIO)。两种模块获得的结果在产量和再现性方面具有可比性。FXN上 [ ¹⁸ F]FAPI-74 放射合成的自动化在 35 分钟内进行，放射化学产率 (RCY) 为 18.5 ± 2.5%（n  = 5，相对于起始 [¹⁸ F]氟化物）。方法转移到 AIO 平台后进行轻微优化，允许以20 ± 2.5% [ n = 3] 的隔离 RCY 生产 [ ¹⁸ F]FAPI-74， 总合成时间为 40 分钟。^{从两个模块获得的 [ 18} F]FAPI-74的放射化学纯度大于 95% 。总体而言，该协议可靠地提供了适用于临床 PET 成像的 [ ¹⁸ F]FAPI-74的无菌和无热原良好生产规范 (GMP) 兼容产品。