Validation of a biotherapeutic immunoaffinity-LC–MS/MS assay in monkey serum: 'plug-and-play' across seven molecules. (August 2016)

• Record Type: Journal Article
• Authors: Kaur, Surinder; Liu, Luna; Cortes, Diego F; Shao, Junlong; Jenkins, Rand; Mylott, William R; Xu, Keyang
• Is Part Of: Bioanalysis. Volume 8:Number 15(2016)
• Page Start: 1565
• Page End: 1577
• Publication Date: 2016-08
• Subjects: 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; Drugs -- Analysis -- Periodicals; 615.19005
• DOI: 10.4155/bio-2016-0117
• Languages: English
• ISSNs: 1757-6180

Abstract

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.