Journal
BIOANALYSIS
Volume 8, Issue 18, Pages 1951-1964Publisher
FUTURE SCI LTD
DOI: 10.4155/bio-2016-0137
Keywords
assay matrix effects; bioanalytical validation; digestion efficiency; GXP bioanalysis; hybrid bioanalysis; immunocapture; protein bioanalysis; protein drug validation; regulated bioanalysis; selectivity
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A refinement of protein LC-MS bioanalysis is to use predigestion immunoaffinity capture to extract the drug from matrix prior to digestion. Because of their increased sensitivity, such hybrid assays have been successfully validated and applied to a number of clinical studies; however, they can also be subject to potential interferences from antidrug antibodies, circulating ligands or other matrix components specific to patient populations and/or dosed subjects. The purpose of this paper is to describe validation experiments that measure immunocapture efficiency, digestion efficiency, matrix effect and selectivity/specificity that can be used during method optimization and validation to test the resistance of the method to these potential interferences. The designs and benefits of these experiments are discussed in this report using an actual assay case study.
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