Production of [68 Ga]Ga-PSMA: Comparing a manual kit-based method with a module-based automated synthesis approach,Journal of Labelled Compounds and Radiopharmaceuticals

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Production of [68 Ga]Ga-PSMA: Comparing a manual kit-based method with a module-based automated synthesis approach
Journal of Labelled Compounds and Radiopharmaceuticals ( IF 0.9 ) Pub Date : 2020-09-10 , DOI: 10.1002/jlcr.3879
Janke Kleynhans _{1,

2} , Sietske Rubow ₁ , Jannie le Roux _{1,

3} , Biljana Marjanovic-Painter ₄ , Jan Rijn Zeevaart _{2,

4} , Thomas Ebenhan _{2,

4,

5}

Affiliation

The labelling of peptides with gallium-68 is often initially performed by manual labelling, but with high clinical demand, other alternatives are needed. Kit-based or automated synthesis are viable options for standardized methods and deemed pharmaceutically more acceptable. This study compares these [68 Ga]Ga-PSMA-11 production methods. Data from 40 kit-based and 40 automated syntheses of [68 Ga]Ga-PSMA-11 were analysed. Pre-set criteria were evaluated including radiochemical purity, radionuclidic purity, chemical purity, physiological acceptability and sterility. The operator time and radiation dose received were measured. The robustness and repeatability of each method were assessed and a comparison of the running costs of each method is also provided. For both the methods all the analysed products met the release criteria. No differences were found in radiochemical purity, radiochemical identity, radionuclidic purity, and sterility. However, radiochemical yield and apparent molar activity showed significant differences. For both methods, whole body radiation exposure to operators was lower than with manual labelling (25 - 40 μSv). The exposure during kit-based labelling (14.5 ± μSv) was seven times higher than that of automated synthesis (2.05 ± 0.99 μSv). The automated synthesis was the more expensive method. Both methods are sound alternatives to manual synthesis and offer higher quality, better radiation protection and a more reliable manufacturing of radiopharmaceuticals.

中文翻译：

[68 Ga]Ga-PSMA 的生产：基于手动套件的方法与基于模块的自动合成方法的比较

用镓 68 标记肽最初通常是通过手动标记进行的，但随着临床需求的增加，需要其他替代方案。基于试剂盒的合成或自动合成是标准化方法的可行选择，并且被认为在药学上更可接受。本研究比较了这些[68 Ga]Ga-PSMA-11 生产方法。分析了 40 次基于试剂盒和 40 次自动合成 [68 Ga]Ga-PSMA-11 的数据。评估预设标准包括放射化学纯度、放射性核素纯度、化学纯度、生理可接受性和无菌性。测量操作时间和接受的辐射剂量。评估了每种方法的稳健性和可重复性，并提供了每种方法的运行成本的比较。对于这两种方法，所有分析的产品均符合释放标准。在放射化学纯度、放射化学特性、放射性核素纯度和无菌性方面没有发现差异。然而，放射化学产率和表观摩尔活性显示出显着差异。对于这两种方法，操作员的全身辐射暴露低于手动标记 (25 - 40 μSv)。基于试剂盒的标记过程中的暴露量 (14.5 ± μSv) 是自动合成过程中的暴露量 (2.05 ± 0.99 μSv) 的七倍。自动合成是更昂贵的方法。这两种方法都是手动合成的合理替代方案，并提供更高的质量、更好的辐射防护和更可靠的放射性药物制造。

更新日期：2020-09-10

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