Validation of a good manufacturing practice procedure for the production of [ 11 C]AZD4747, a CNS penetrant KRAS G12c inhibitor.
Miguel A Cortés GonzálezAntonia A HögnäsbackaChrister HalldinMagnus SchouPublished in: Journal of labelled compounds & radiopharmaceuticals (2023)
AZD4747 is a KRAS G12C inhibitor recently shown to cross the non-human primate blood-brain barrier efficiently. In the current study, a GMP-compliant production of [ 11 C]AZD4747 was developed to enable PET studies in human subjects. The validated procedure afforded [ 11 C]AZD4747 as an injectable solution in good radioactivity yield (1656 ± 532 MBq), excellent radiochemical purity (100%), and a molar activity of 77 ± 13 GBq/μmol at the end of the synthesis, which took 46 ± 1 min from the end of the bombardment. Quality control on the final product was performed satisfactorily and met all acceptance criteria.
Keyphrases
- blood brain barrier
- endothelial cells
- quality control
- induced pluripotent stem cells
- primary care
- minimally invasive
- healthcare
- pluripotent stem cells
- cerebral ischemia
- computed tomography
- escherichia coli
- tyrosine kinase
- cystic fibrosis
- pseudomonas aeruginosa
- quality improvement
- biofilm formation
- pet imaging
- candida albicans
- solid state