Hörmann Anton Amadeus, Schweighofer-Zwink Gregor, Rendl Gundula, Türk Kristina, Nadeje Samuel, Haas Kristina, Jung Theresa, Huber-Schönauer Ursula, Hehenwarter Lukas, Beheshti Mohsen, Pirich Christian
Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Paracelsus Medical University, 5020 Salzburg, Austria.
Pharmaceuticals (Basel). 2024 Aug 29;17(9):1141. doi: 10.3390/ph17091141.
[Ga]Ga-FAP-2286 is a new peptide-based radiopharmaceutical for positron-emission tomography (PET) that targets fibroblast activation protein (FAP). This article describes in detail the automated synthesis of [Ga]Ga-FAP-2286 using a commercially available synthesis tool that includes quality control for routine clinical applications. The synthesis was performed using a Scintomics GRP-3V module and a GMP grade Ge/Ga generator. A minor alteration for transferring the eluate to the module was established, eliminating the need for new method programming. Five batches of [Ga]Ga-FAP-2286 were tested to validate the synthesis. A stability analysis was conducted up to 3 h after production to determine the shelf-life of the finished product. The automated synthesis on the Scintomics GRP-3V synthesis module was found to be compliant with all quality control requirements. The shelf-life of the product was set to 2 h post-production based on the stability study. A patient suffering from cholangiocellular carcinoma that could not be clearly detected by conventional imaging, including a [F]FDG-PET/CT, highlights the potential use of [Ga]Ga-FAP-PET/CT.
[镓]镓-FAP-2286是一种新型的基于肽的正电子发射断层扫描（PET）放射性药物，其靶向成纤维细胞活化蛋白（FAP）。本文详细描述了使用市售合成工具自动合成[镓]镓-FAP-2286的过程，该过程包括用于常规临床应用的质量控制。合成使用Scintomics GRP-3V模块和GMP级锗/镓发生器进行。建立了将洗脱液转移至模块的微小改动，无需新的方法编程。测试了五批[镓]镓-FAP-2286以验证合成过程。在生产后长达3小时进行稳定性分析，以确定成品的保质期。发现Scintomics GRP-3V合成模块上的自动合成符合所有质量控制要求。根据稳定性研究，产品的保质期设定为生产后2小时。一名患有胆管细胞癌的患者，传统成像（包括[氟]FDG-PET/CT）无法清晰检测到，这凸显了[镓]镓-FAP-PET/CT的潜在用途。
