A workflow for absolute quantitation of large therapeutic proteins in biological samples at intact level using LC-HRMS.

作者: Wenying Jian , Lijuan Kang , Lyle Burton , Naidong Weng

DOI: 10.4155/BIO-2016-0096

关键词: BioanalysisMonoclonal antibodyFunction (biology)ChromatographyAntibodies monoclonalWorkflowChemistryProtein therapeutics

摘要: Aim: The commonly used LC–MS workflow to quantify protein therapeutics in biological samples is ‘bottom-up’ approach. In this study, the aim establish ‘top-down’ approach for absolute quantitation of therapeutic antibodies or proteins similar sizes at intact level. Materials & methods: Using a recombinant human monoclonal antibody as model molecule, we present measure large plasma level based on deconvoluted high-resolution MS (HRMS) peaks. A novel MultiQuant™ software function was developed automatically deconvolute peaks and process data. Results conclusion: showed satisfying performance. This proof concept study demonstrating feasibility bioanalysis using LC-HRMS.

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