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

A fully automated and GMP compliant synthesis of the synaptic vesicle glycoprotein 2A (SV2A) PET radioligand, [18F]SynVesT-1 was developed using a commercially available radiosynthesis module. The protocol reliably provides a pharmaceutical grade solution of [18F]SynVesT-1 suitable for clinical studies. [18F]SynVesT-1 (also known as [18F]SDM-8 or [18F]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 an18F-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 [18F]SynVesT-1 suitable for clinical studies in humans. [18F]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 [18F]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 3...
Source: Journal of Labelled Compounds and Radiopharmaceuticals - Category: Biochemistry Authors: Tags: PRACTITIONER PROTOCOL ‐ SYNTHESIS Source Type: research