Fully-automated synthesis of 177Lu labelled FAPI derivatives on the module modular lab-Eazy

Background: To the best of our knowledge, manually production of [¹⁷⁷Lu]Lu-FAPI radiopharmaceutical derivatives has been only described in literature. In this work, a fully-automated [¹⁷⁷Lu]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 [¹⁷⁷Lu]Lu-FAPI derivatives was achieved on the Modular Lab Eazy (ML Eazy) with high radiochemical yield ([¹⁷⁷Lu]Lu-FAPI-04; 88% ± 3, [¹⁷⁷Lu]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 [¹⁷⁷Lu]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.