Sarah Spreckelmeyer1, Matthias Balzer2, Simon Poetzsch2, Winfried Brenner2. 1. Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Nuclear Medicine, Augustenburger Platz 1, 13353, Berlin, Germany. sarah.spreckelmeyer@charite.de. 2. Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Department of Nuclear Medicine, Augustenburger Platz 1, 13353, Berlin, Germany.
Abstract
BACKGROUND: [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 only performed manually. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on two different commercially available synthesis modules in order to make the tracer readily available for clinical application. RESULTS: The synthesis of [68Ga]Ga-FAPI-46 with different amounts of precursor (10-50 μg) on the Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy) from Eckert & Ziegler 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. 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.
BACKGROUND: [68Ga]Ga-<span class="Chemical">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 only performed manually. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on two different commercially available synthesis modules in order to make the tracer readily available for clinical application. RESULTS: The synthesis of [68Ga]Ga-FAPI-46 with different amounts of precursor (10-50 μg) on the Modular Lab PharmTracer (MLPT) and Modular Lab eazy (ML eazy) from Eckert & Ziegler 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. 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.
Authors: Andrzej Mular; Abraham Shanzer; Henryk Kozłowski; Isabella Hubmann; Matthias Misslinger; Julia Krzywik; Clemens Decristoforo; Elzbieta Gumienna-Kontecka Journal: Inorg Chem Date: 2021-11-16 Impact factor: 5.165
Authors: Chiara Da Pieve; Marta Costa Braga; David R Turton; Frank A Valla; Pinar Cakmak; Karl-Heinz Plate; Gabriela Kramer-Marek Journal: Molecules Date: 2022-01-20 Impact factor: 4.411