The development of an automated and GMP compliant FASTlab™ Synthesis of [18F]GE-180; a radiotracer for imaging translocator protein (TSPO)

摘要: The level of the translocator protein (TSPO) increases dramatically in microglial cells when are activated response to neuronal injury and insult. radiotracer [18F]GE-180 binds selectively with high affinity TSPO can therefore be used measure neuroinflammation a variety disease states. An optimized, automated synthesis has been developed for GE FASTlab™ synthesizer. entire process takes place on single-use cassette. radiolabelling is performed by nucleophilic fluorination S- enantiomer mesylate precursor. crude product purified post-radiolabelling using two solid-phase extraction cartridges integrated Experimental design multivariate data analysis were assess robustness, critical steps optimized respect efficacy quality. The average radiochemical yield 48% (RSD 6%, non-decay corrected), time including purification approximately 43 min. purity ≥95% radioactive concentration ≤1100 MBq/mL. total amount precursor-related chemical impurities 1–2 µg/mL. The use results robust GMP compliant consistent performance across positron emission tomography (PET) centers.