Structural comparison of two anti-CD20 monoclonal antibody drug products using middle-down mass spectrometry

The Analyst
Bo WangMichael T Boyne

Abstract

Liquid chromatography-mass spectrometry (LC-MS) is an information rich analytical tool that can provide fast, robust and sensitive characterization of protein therapeutics for quality assurance and structural comparison. Herein, structural characterization of two anti-CD20 monoclonal antibodies obtained from two different sources was performed using a middle-down LC-MS strategy to determine if they can be analytically differentiated. Through the use of a specific enzymatic digestion method using IdeS with subsequent LC-MS analysis, we show that the anti-CD20 monoclonal antibody that has been approved by the FDA can be partially characterized and differentiated analytically from an Indian sourced product that lacks FDA approval. In comparison to the FDA-approved product, differential modifications to both the N- and C-termini result in increased charge heterogeneity for the Indian product. In addition, significant differences in the intensities of the observed glycoforms between the two antibodies were detected. While this study assesses only one lot of each of a FDA approved drug product and the Indian sourced drug product, the observed differences may represent process specific fingerprints that could be useful for surveillanc...Continue Reading

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Citations

Apr 4, 2016·Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences·Zichuan ZhangJulia Ding
Jun 19, 2015·Analytical Chemistry·Michaella J LevyMichael T Boyne
Sep 10, 2014·Analytical and Bioanalytical Chemistry·Laura K HmielMichael T Boyne
Jun 22, 2016·Journal of Pharmaceutical and Biomedical Analysis·Maria Kristina ParrHouda Montacir
Jan 21, 2017·MAbs·Izabela SokolowskaPing Hu
Apr 26, 2018·Expert Review of Proteomics·Deepali RathoreSarah Rogstad

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