A universal surrogate peptide to enable LC-MS/MS bioanalysis of a diversity of human monoclonal antibody and human Fc-fusion protein drug candidates in pre-clinical animal studies.

摘要: For the development of human antibody Fc (fraction crystallizable) region-containing therapeutic protein candidates, which can be either monoclonal antibodies (mAbs) or pharmacologically active proteins/peptides fused to region Immunoglobulin G (IgG), reliable quantification these proteins in animal pharmacokinetic study plasma samples is critical. LC-MS/MS has emerged as a promising assay platform for this purpose. assays used bioanalysis candidates frequently rely upon 'signature' surrogate peptide whose sequence unique analyte interest. One drawback signature approach that new must developed each protein. To address issue, we propose an alternative 'universal peptide' from all nonclinical species. A single tryptic was identified most Fc-containing candidates. An LC-MS-MS method based shown capable supporting diversity commonly