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• W2472300727 abstract "Biotherapeutics development requires validated assays in biological matrices for pharmacokinetic assessment. Historically, ligand-binding assays have been the predominant platform available. Recently, alternative hybrid methods, combining ligand-binding analyte enrichment with LC-MS detection have emerged. Methodology & results: The validation of an immunoaffinity (IA)-LC-MS/MS method to quantify a monoclonal antibody biotherapeutic in cynomolgus monkey serum is described. This method includes immunoaffinity capture of the antibody in serum, followed by enzymatic digestion and detection of a framework peptide. Using similar method conditions, six additional biotherapeutic assays were readily validated in different nonhuman mammalian species, including mouse, rat and monkey.The immunoaffinity-LC-MS/MS assay validation results across seven antibody therapeutics, using comparable conditions, illustrate the 'plug-and-play' nature of the IA-LC-MS/MS mAb framework peptide assay format." @default.
• W2472300727 created "2016-07-22" @default.
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• W2472300727 date "2016-08-01" @default.
• W2472300727 modified "2023-10-13" @default.
• W2472300727 title "Validation of a biotherapeutic immunoaffinity-LC–MS/MS assay in monkey serum: ‘plug-and-play’ across seven molecules" @default.
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• W2472300727 doi "https://doi.org/10.4155/bio-2016-0117" @default.
• W2472300727 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/27396481" @default.
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