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Abstract
Background: Monoclonal antibodies are the fastest growing class of protein therapeutics. Ligand-binding assays have been the technique of choice for the quantification of these large proteins; however, LC–MS and more recently LC–HRMS have been gaining momentum as robust alternatives for the bioanalysis of antibodies in biological matrices. Results: Optimization of sample preparation and LC–HRMS analysis in MRMHR mode has allowed us to develop a highly specific dual-peptide targeted assay for the quantification of Rituximab, in human plasma. The linearity of the assay was established from 1.0 to 200 µg/ml for both light and heavy chain surrogate peptides, with accuracy and precision within 15%. Conclusion: LC–HRMS can be an effective tool for the quantification of monoclonal antibodies in regulated bioanalysis.
Financial & competing interests disclosure
The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.