Comparison of originator and biosimilar monoclonal antibodies using HRMS, Fc affinity chromatography, and 2D-HPLC
Author:
Funder
Bundesministerium für Wirtschaft und Energie
Publisher
Springer Science and Business Media LLC
Subject
Biochemistry,Analytical Chemistry
Link
https://link.springer.com/content/pdf/10.1007/s00216-022-04236-8.pdf
Reference21 articles.
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3. Beck A, Sanglier-Cianferani S, Van Dorsselaer A. Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry. Anal Chem. 2012;84(11):4637–46. https://doi.org/10.1021/ac3002885.
4. Agency EM (2012) Guideline on similar biological medicinal products containing monoclonal antibodies – non-clinical and clinical issues. London
5. Shukla AA, Thommes J. Recent advances in large-scale production of monoclonal antibodies and related proteins. Trends Biotechnol. 2010;28(5):253–61. https://doi.org/10.1016/j.tibtech.2010.02.001.
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1. Development of a Two-dimensional Liquid Chromatography High-Resolution Mass Spectrometry Method for the Characterization of Monoclonal Antibodies in Cell-Free Culture Supernatant via FcR Affinity Chromatography;Chromatographia;2022-12-12
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