Fully-automated production of [⁶⁸Ga]Ga-FAPI-46 for clinical application

Ziel/Aim [⁶⁸Ga]Ga-FAPI-46 is a promising radiopharmaceutical for in vivo detection of the fibroblast activation protein by positron emission tomography. Until now, the synthesis of [⁶⁸Ga]Ga-FAPI-46 has been performed manually [1],[2]. Our aim was to evaluate an automated synthesis of this radiopharmaceutical on two different commercially available synthesis modules in order to make the tracer readily available for clinical application.

Methodik/Methods Different loads of FAPI-46 (10-50 µg) were investigated on two fully-automated synthesis modules from Eckert & Ziegler, Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy) After the synthesis, the radioactivity distributions on the cassettes were evaluated. In addition, quality control parameters (e.g. radiochemical purity, endotoxins, pH, and sterility) were analyzed with standard protocols according to the European Pharmacopoeia.

Ergebnisse/Results The synthesis of [⁶⁸Ga]Ga-FAPI-46 with different amounts of precursor (10-50 µg) on both modules) with a customized synthesis template and a customized single-use cassette yielded best results with 50 µg FAPI-46 for clinical multi-dose application. All relevant quality control parameters tested (e.g. sterility, stability and radiochemical purity) were in accordance with the European Pharmacopoeia.

Schlussfolgerungen/Conclusions [⁶⁸Ga]Ga-FAPI-46 was successfully synthesized fully-automated on the synthesis modules Modular Lab PharmTracer and ML eazy and is, thus, available for multi-dose application in clinical settings.

• Literatur/References

• 1 Lindner T, Loktev A, Altmann A, Giesel F, Kratochwil C, Debus J, Jager D, Mier W, Haberkorn U. , Development of Quinoline-Based Theranostic Ligands for the Targeting of Fibroblast; Activation Protein. J Nucl Med 2018; 59 (09) 1415-1422.
• 2 Loktev A, Lindner T, Burger E. M, Altmann A, Giesel F, Kratochwil C, Debus J, Marme F, Jager D, Mier W, Haberkorn U. , Development of Fibroblast Activation Protein-Targeted; Radiotracers with Improved Tumor Retention. J Nucl Med 2019; 60 ( (10) 1421-1429.

Publication History

Article published online:
08 April 2021