ArticleEJNMMI radiopharmacy and chemistry2025
cGMP-compliant high-yield automated production of [
Article in EJNMMI radiopharmacy and chemistry, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundFibroblast activation protein inhibitor (FAPI)-based positron emission tomography (PET) radiopharmaceuticals have shown promise for imaging cancer-associated fibroblasts (CAFs), a key component of the tumor microenvironment. FAPI radiopharmaceuticals offer high tumor-to-background contrast and are not influenced by hyperglycemia. Among these, [
resultsThe automated GMP-compliant production was validated in three independent runs, with an average decay-corrected yield and apparent molar activity of 50 ± 10% and 1124 ± 254 GBq/µmol at the end of synthesis, respectively. Total synthesis time was 30 min. Quality control used validated analytical methods, including an optimized radio-HPLC protocol, ensuring regulatory compliance and batch consistency. [
conclusionsA robust, fully automated, and GMP-compliant production process for [
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