A comprehensive approach for evaluating charge heterogeneity in biosimilars-Reference-Cited by-同舟云学术

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A comprehensive approach for evaluating charge heterogeneity in biosimilars

Published:2018-03 Issue: Volume:115 Page:19-24
ISSN:0928-0987
Container-title:European Journal of Pharmaceutical Sciences
language:en
Short-container-title:European Journal of Pharmaceutical Sciences

Author:

Xiao Zhiliang,Yin Xiaohang,Han Lina,Sun Baiping,Shen Zhenduo,Liu Wanhui,Yu Fei^ORCID

Publisher

Elsevier BV

Subject

Pharmaceutical Science

Reference22 articles.

1. Approval of the first biosimilar antibodies in Europe: a major landmark for the biopharmaceutical industry;Beck;MAbs,2013

2. Effects of charge on antibody tissue distribution and pharmacokinetics;Boswell;Bioconjug. Chem.,2010

3. Formation of pyroglutamic acid from N-terminal glutamic acid in immunoglobulin gamma antibodies;Chelius;Anal. Chem.,2006

4. Characterization of acidic and basic variants of IgG1 therapeutic monoclonal antibodies based on non-denaturing IEF fractionation;Dada;Electrophoresis,2015

5. C-terminal lysine variants in fully human monoclonal antibodies: investigation of test methods and possible causes;Dick;Biotechnol. Bioeng.,2008

Cited by 9 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Highly purified charge variants of a proposed biosimilar to Omalizumab: impact on in vitro potency and stability under thermal stress;Bioprocess and Biosystems Engineering;2023-12-29

2. Combination of On-Line and Off-Line Two-Dimensional Liquid Chromatography-Mass Spectrometry for Comprehensive Characterization of mAb Charge Variants and Precise Instructions for Rapid Process Development;International Journal of Molecular Sciences;2023-10-14

3. Improvement of monoclonal antibody stability by modulating trace metal iron concentration in cell culture media: A case study;Process Biochemistry;2023-02

4. Risk-Based Control Strategies of Recombinant Monoclonal Antibody Charge Variants;Antibodies;2022-11-20

5. Characterization of N-Terminal Glutamate Cyclization in Monoclonal Antibody and Bispecific Antibody Using Charge Heterogeneity Assays and Hydrophobic Interaction Chromatography;Journal of Pharmaceutical Sciences;2022-02

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