Automated radiosynthesis of [68 Ga]Ga-PSMA-11 and [177 Lu]Lu-PSMA-617 on the iPHASE MultiSyn module for clinical applications.

Abstract

PSMA-targeted imaging and therapy of prostate cancer using theranostic pairs is rapidly changing clinical practice. To facilitate clinical trials, fully automated procedures for the radiosyntheses of [68 Ga]Ga-PSMA-11 and [177 Lu]Lu-PSMA-617 were developed from commercially available precursors using the cassette based iPHASE MultiSyn module. Formulated and sterile radiopharmaceuticals were obtained in 76 ± 3% (n = 20) and 91 ± 4% (n = 15) radiochemical yields after 17 and 20 minutes, respectively. Radiochemical purity was always > 95% and molar activities exceeded 792 ± 100 GBq/μmol and 88 ± 6 GBq/μmol, respectively. Quality control showed conformity with all relevant release criteria and radiopharmaceuticals were used in the clinic.