Journal
BIOANALYSIS
Volume 8, Issue 15, Pages 1565-1577Publisher
FUTURE SCI LTD
DOI: 10.4155/bio-2016-0117
Keywords
biotherapeutic; calibration standard; high performance LC; immunoaffinity; LC-MS/MS; lower limit of quantification; percent coefficient of variation; quality control; standard deviation; upper limit of quantification; validation
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Background: 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. Conclusion: 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.
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