Abstract
[Ga-68]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-68]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-68/Ga-68 generator. A minor alteration for transferring the eluate to the module was established, eliminating the need for new method programming. Five batches of [Ga-68]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 [18F]FDG-PET/CT, highlights the potential use of [Ga-68]Ga-FAP-PET/CT.
Originalsprache | Englisch |
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Aufsatznummer | 1141 |
Seitenumfang | 15 |
Fachzeitschrift | Pharmaceuticals |
Jahrgang | 17 |
Ausgabenummer | 9 |
DOIs | |
Publikationsstatus | Veröffentlicht - Sept. 2024 |