Good manufacturing procedure production of [ 18 F]SynVesT‐1 , a radioligand for in vivo positron emission tomography imaging of synaptic vesicle glycoprotein 2A

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[ 18 F]SynVesT‐1 (also known as [ 18 F]SDM‐8 or [ 18 F]MNI‐1126) is a potent and selective synaptic vesicle glycoprotein 2 (SV2A) positron emission tomography (PET) imaging agent. In order to fulfill the increasing clinical demand of an 18 F‐labeled SV2A PET ligand, we have developed a fully automated procedure to provide a sterile and pyrogen‐free good manufacturing procedure (GMP)‐compliant product of [ 18 F]SynVesT‐1 suitable for clinical studies in humans. [ 18 F]SynVesT‐1 is synthesized via a rapid copper‐mediated radiofluorination protocol. The procedure was developed and established on a commercially available module, TracerMaker (ScanSys Laboratorieteknik ApS, Copenhagen, Denmark), a synthesis platform originally developed to conduct carbon‐11 radiochemistry. From ~130 GBq (end‐of‐bombardment), our newly developed procedure enabled us to prepare [ 18 F]SynVesT‐1 in an isolated radioactivity yield of 14,220 ± 800 MBq ( n = 3), which corresponds to a radiochemical yield (RCY) of 19.5 ± 0.5%. The radiochemical purity (RCP) and enantiomeric purity of each of the final formulated batches exceeded 98%. The overall synthesis time was 90 min and the molar activity was 330 ± 60 GBq/μmol (8.9 ± 1.6 Ci/μmol). The produced [ 18 F]SynVesT‐1 was stable over 8 h at room temperature and is suitable for in vivo PET imaging studies in human subjects.