用于临床应用的[镓]镓-FAPI-46的全自动生产。
Fully-automated production of [Ga]Ga-FAPI-46 for clinical application.
作者信息
Spreckelmeyer Sarah, Balzer Matthias, Poetzsch Simon, Brenner Winfried
机构信息
Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Nuclear Medicine, Augustenburger Platz 1, 13353, Berlin, Germany.
出版信息
EJNMMI Radiopharm Chem. 2020 Dec 17;5(1):31. doi: 10.1186/s41181-020-00112-x.
BACKGROUND
[Ga]Ga-FAPI-46 is a promising radiopharmaceutical for in vivo detection of the fibroblast activation protein by positron emission tomography. Until now, the synthesis of [Ga]Ga-FAPI-46 has been only performed manually. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on two different commercially available synthesis modules in order to make the tracer readily available for clinical application.
RESULTS
The synthesis of [Ga]Ga-FAPI-46 with different amounts of precursor (10-50 μg) on the Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy) from Eckert & Ziegler with a customized synthesis template and a customized single-use cassette yielded best results with 50 μg FAPI-46 for clinical multi-dose application. All relevant quality control parameters tested (e.g. sterility, stability and radiochemical purity) were in accordance with the European Pharmacopoeia.
CONCLUSIONS
[Ga]Ga-FAPI-46 was successfully synthesized fully-automated on the synthesis modules Modular Lab PharmTracer and ML eazy and is, thus, available for multi-dose application in clinical settings.
背景
[镓]镓-FAPI-46是一种很有前景的放射性药物，可通过正电子发射断层扫描在体内检测成纤维细胞活化蛋白。到目前为止，[镓]镓-FAPI-46的合成仅通过手工进行。我们的目的是评估在两种不同的商用合成模块上对这种放射性药物进行自动化合成，以便使该示踪剂易于用于临床应用。
结果
使用定制的合成模板和定制的一次性盒式装置，在Eckert & Ziegler公司的模块化实验室PharmTracer（MLPT）和模块化实验室eazy（ML eazy）上，用不同量的前体（10 - 50μg）合成[镓]镓-FAPI-46，对于临床多剂量应用，50μg FAPI-46产生的结果最佳。测试的所有相关质量控制参数（如无菌性、稳定性和放射化学纯度）均符合欧洲药典。
结论
[镓]镓-FAPI-46在模块化实验室PharmTracer和ML eazy合成模块上成功实现了全自动化合成，因此可用于临床环境中的多剂量应用。
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