cGMP-compliant high-yield automated production of [18F]AlF-FAPI-74: optimization of quality control and evaluation of molar dose impact

A robust, fully automated, and GMP-compliant production process for [¹⁸F]AlF-FAPI-74 is reported with high yield, purity, and stability, suitable for centralized production and distribution. The improved radio-HPLC method enhances quality control precision by accurately quantifying radiochemical and chemical purity. In vivo experiments confirmed fast tumor uptake of [¹⁸F]AlF-FAPI-74. While a clear mass effect on tumor-to-background ratios was observed in preclinical studies, high apparent molar activity resulted in excellent contrast in a clinical setting.