期刊
BIOANALYSIS
卷 8, 期 16, 页码 1679-1691出版社
FUTURE SCI LTD
DOI: 10.4155/bio-2016-0096
关键词
bioanalysis; intact level; LC-HRMS; protein bioanalysis; quantitation
Aim: The commonly used LC-MS workflow to quantify protein therapeutics in biological samples is 'bottom-up' approach. In this study, the aim is to establish 'top-down' approach for absolute quantitation of therapeutic antibodies or proteins of similar sizes in biological samples at intact level. Materials & methods: Using a recombinant human monoclonal antibody as the model molecule, we present a workflow to measure large therapeutic proteins in plasma at intact level based on deconvoluted high-resolution MS (HRMS) peaks. A novel MultiQuant (TM) software function was developed to automatically deconvolute the peaks and process the data. Results & conclusion: The workflow showed satisfying performance. This is a proof of concept study demonstrating the feasibility of bioanalysis of large therapeutic proteins at intact level using LC-HRMS.
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