Fully automated production of the fibroblast activation protein radiotracer [18F]FAPI‐74. (29th May 2021) - Dahl, Kenneth
Abstract : We report herein an efficient and fully automated protocol for the radiosynthesis of [ 18 F]FAPI‐74, a new positron emission tomography (PET) radiopharmaceutical for in vivo detection of the fibroblast activation protein. [ 18 F]FAPI‐74 was synthesized via a rapid [ 18 F]aluminum fluoride coordination reaction, which was first developed on the flexible GE TRACERLab FX2N (FXN) platform and later translated to the cassette‐based module Trasis AllInOne (AIO). The results obtained with both modules were comparable in terms of yield and reproducibility. Automation of [ 18 F]FAPI‐74 radiosynthesis on the FXN was carried out in 35 min with a radiochemical yield (RCY) of 18.5 ± 2.5% ( n = 5, relative to starting [ 18 F]fluoride). Method transfer to the AIO platform following minor optimizations allowed for the production of [ 18 F]FAPI‐74 in an isolated RCY of 20 ± 2.5% [ n = 3] with an overall synthesis time of 40 min. The radiochemical purity was greater than 95% for [ 18 F]FAPI‐74, obtained from both modules. Overall, the protocol reliably provides a sterile and pyrogen‐free good manufacturing practice (GMP) compliant product of [ 18 F]FAPI‐74 suitable for clinical PET imaging. Abstract : We report herein the first successfully automated radiosynthesis of the fibroblast activation protein (FAP) radiotracer [ 18 F]FAPI‐74 using two commercially available modules, GE TRACERLab FX2 N and Trasis AllInOne. [ 18 F]FAPI‐74 was obtained with high and reproducible radiochemical yields using both modules. Overall, the protocol reliably provides a sterile and pyrogen‐free good manufacturing practice (GMP) compliant product suitable for clinical positron emission tomography (PET) imaging.