Abstract
BACKGROUND: To the best of our knowledge, manually production of [(177)Lu]Lu-FAPI radiopharmaceutical derivatives has been only described in literature. In this work, a fully-automated [(177)Lu]Lu-FAPI synthesis has been well designed for the first time using commercially available synthesis module. In addition to the development of an automated system with disposable cassette, quality control (QC) and stability studies were comprehensively presented. RESULTS: A fully automated synthesis of [(177)Lu]Lu-FAPI derivatives was achieved on the Modular Lab Eazy (ML Eazy) with high radiochemical yield ([(177)Lu]Lu-FAPI-04; 88% ± 3, [(177)Lu]Lu-FAPI-46; 86% ± 3). Chromatographic analysis indicated the formation of radiosynthesis with an absolute radiochemical purity (99%). Stability experiments clarified the durability of the products within 4 days. All obtained specifications are consistent to European Pharmacopoeia. CONCLUSION: A fully automated synthesis of [(177)Lu]Lu-FAPI radiopharmaceuticals was accomplished regarding quality control standards and quality assurance by using commercially available a modular approach namely ML Eazy with disposable customized cassette and template.