Fast high performance liquid chromatography in PET quality control and metabolite analysis.
Quality control (QC) and metabolite analysis on compounds labelled with positron emitting isotopes used for positron emission tomography (PET) studies are constrained by time. For carbon-11 labelled tracers, it is generally accepted that the QC and subsequent release process should take no longer than 20 minutes to ensure both high product specific activity and activity in order to meet the aims of the studies in which it is used. From a regulatory point of view, PET manufacturing and associated QC testing are increasingly expected to meet Good Manufacturing Practices (GMP) standards. The challenge for the PET QC laboratory of today is to marry the requirement for fast testing with meeting applicable regulations and guidance. Although regulatory requirements are typically less of an issue for PET metabolite analysis, it has a significant impact on the ability to perform quantitative PET pharmacokinetic analysis on the acquired PET imaging data. This paper aims to provide a general overview and guidance on good practice for PET HPLC quality control and aims to highlight some recent developments that may aid in speeding up both PET QC and metabolite HPLC analysis methods.
Passchier
J
J
GlaxoSmithkline, Clinical Imaging Center, Imperial College, Hammersmith Hospital, London, UK. jan.2.passchier@gsk.com
D002851:Chromatography, High Pressure Liquid / Q000592:standards*; D004353:Drug Evaluation, Preclinical / Q000592:standards*; D038622:Internationality; D049268:Positron-Emission Tomography / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000592:standards*; D019275:Radiopharmaceuticals / Q000493:pharmacokinetics* / Q000592:standards*
D019275:Radiopharmaceuticals