[11C]carbon monoxide ([11C]CO) is a versatile synthon for radiolabeling of drug‐like molecules for imaging studies with positron emission tomography (PET). We here report the development of a novel, user‐friendly, fully automated, and good manufacturing practice (GMP) compliant low‐pressure synthesis module for 11C‐carbonylation reactions using [11C]CO. In this synthesis module, [11C]CO was reliably prepared from cyclotron‐produced [11C]carbon dioxide ([11C]CO2) by reduction over heated molybdenum and delivered to the reaction vessel within 7 min after end of bombardment, with an overall radiochemical yield (RCY) of 71%. [11C]AZ13198083, a histamine type‐3 receptor ligand, was used as a model compound to assess the functionality of the radiochemistry module. At full batch production conditions (55 μA, 30 min), our newly developed low‐pressure 11C‐carbonylation apparatus enabled us to prepare [11C]AZ13198083 in an isolated radioactivity of 8540 ± 1400 MBq (n = 3). The radiochemical purity of each of the final formulated batches exceeded 99%, and all other quality control tests results conformed with specifications typically set for carbon‐11 labeled radiopharmaceuticals. In conclusion, this novel radiochemistry system offers a convenient GMP compliant production drugs and radioligands for imaging studies in human subjects.

中文翻译：

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全自动低压 [11 C]CO 羰基化装置的开发

[11C] 一氧化碳 ([11C]CO) 是一种多功能合成子，用于放射性标记药物样分子，用于正电子发射断层扫描 (PET) 成像研究。我们在此报告了使用 [11C]CO 进行 11C-羰基化反应的新型、用户友好、全自动且符合良好生产规范 (GMP) 的低压合成模块的开发。在该合成模块中，[11C]CO 是由回旋加速器产生的 [11C]二氧化碳（[11C]CO2）通过加热钼还原而可靠地制备的，并在轰击结束后 7 分钟内输送到反应容器中，具有整体放射化学产率 (RCY) 为 71%。[11C]AZ13198083，一种组胺 3 型受体配体，被用作评估放射化学模块功能的模型化合物。在全批量生产条件下（55 μA，30 分钟），我们新开发的低压 11C 羰基化装置使我们能够以 8540 ± 1400 MBq（n = 3）的孤立放射性制备 [11C]AZ13198083。每个最终配制批次的放射化学纯度均超过 99%，所有其他质量控制测试结果均符合通常为碳 11 标记的放射性药物设定的规范。总之，这种新型放射化学系统为人体成像研究提供了一种方便的符合 GMP 的生产药物和放射配体。