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. Graphical abstract

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Radiolabeled phosphonates have found widespread applications in nuclear medicine for the treatment of bone metastases. Even though considerable attention has been devoted to the administration of radiolabeled phosphonates to the patients, quality control (QC) studies belong to detection of them are still speculative and need to be improved. Herein, practical, efficient, and more reliable high‐performance liquid chromatograpy (HPLC) methods were described for the first time. Radiochemical purity was easily determined by our developed analytical methods. N,N‐Dimethylhexylamine and N,N‐dimethyltetradecylamine were furnished as suitable ion pair reagents for the identification of radiopharmaceutical products. Effects of column type, pH of the mobile phase, and salt concentration were also examined.

Backround: 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 employed. Results A fully automated synthesis of [177Lu]Lu-FAPI derivatives was achieved on the Modular Lab Eazy (ML Eazy) with high radiochemical yield (85–90%). 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 were accomplished regarding quality control standards and quality assurance by using commercially available a modular approach namely ML Eazy with disposable customized cassette and template.

After publication of the original article (Eryilmaz and Kilbas 2021), the authors identified an error in Figs. 1 and 2. The correct figures are given below.The original article has been corrected.Reference Eryilmaz, Kilbas. Fully-automated synthesis of 177Lu labelled FAPI derivatives on the module modular lab-Eazy. EJNMMI