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Current Mass Spectrometric Tools for the Bioanalyses of Therapeutic Monoclonal Antibodies and Antibody-Drug Conjugates

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Abstract

The increase in the use of therapeutic monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) has made the detailed bioanalysis of these drugs essential not only for planning optimal therapeutic programs for clinical practice, but also for evaluating the biological equivalencies in the development of other biosimilars. The ligand binding assays that are widely in use now are being replaced rapidly by the highly accurate, sensitive, and selective analytical method using a mass spectrometer. This review will discuss the progress in and challenges observed during the development of a mass spectrometry-based bioanalytical method for therapeutic mAbs and ADCs.

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Authors and Affiliations

  1. Laboratory of Analytical and Bio-Analytical Chemistry School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga, Shizuoka, 422-8526, Japan

    Kenichiro Todoroki, Tomohiro Yamada, Hajime Mizuno & Toshimasa Toyo'oka

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  1. Kenichiro Todoroki
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  2. Tomohiro Yamada
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  3. Hajime Mizuno
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  4. Toshimasa Toyo'oka
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Correspondence to Kenichiro Todoroki.

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Todoroki, K., Yamada, T., Mizuno, H. et al. Current Mass Spectrometric Tools for the Bioanalyses of Therapeutic Monoclonal Antibodies and Antibody-Drug Conjugates. ANAL. SCI. 34, 397–406 (2018). https://doi.org/10.2116/analsci.17R003

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