Fully-automated production of [(68)Ga]Ga-PentixaFor on the module Modular Lab-PharmTracer.

BACKGROUND: PentixaFor is a promising radiopharmaceutical for positron emission tomography in the detection of different tumor entities and other diseases. Until now, the synthesis of [(68)Ga]Ga-PentixaFor was reported for the automated synthesis module from Scintomics(R) only. Our aim was to evaluate the automated synthesis of this radiopharmaceutical on a different module in order to make it available for a broader community. RESULTS: The synthesis of [(68)Ga]Ga-PentixaFor with different amounts of PentixaFor (50 mug, 30 mug and 20 mug) on the Modular Lab PharmTracer (MLPT) from Eckert & Ziegler with the already established synthesis template for [(68)Ga]Ga-DOTATOC yielded best results with 50 mug PentixaFor for clinical multi-dose application. All different quality control parameters tested (e.g. sterility, stability and radiochemical purity) were in accordance with the European Pharmacopoeia. CONCLUSIONS: [(68)Ga]Ga-PentixaFor was successfully synthesized fully-automated on the synthesis module Modular Lab PharmTracer and can be used for multi-dose application in clinical settings.