A global comparability approach for biosimilar monoclonal antibodies using LC–tandem MS based proteomics

SL Chen, SL Wu, LJ Huang, JB Huang… - Journal of pharmaceutical …, 2013 - Elsevier
Liquid chromatography–tandem mass spectrometry-based proteomics for peptide mapping
and sequencing was used to characterize the marketed monoclonal antibody trastuzumab …

[HTML][HTML] Biosimilar, biobetter, and next generation antibody characterization by mass spectrometry

A Beck, S Sanglier-Cianférani… - Analytical …, 2012 - ACS Publications
This Feature will introduce the strategies of therapeutic antibodies (mAbs) in-depth
characterization by mass spectrometry (MS) and discuss analytical comparison of biosimilar …

Cutting‐edge mass spectrometry characterization of originator, biosimilar and biobetter antibodies

A Beck, F Debaene, H Diemer… - Journal of Mass …, 2015 - Wiley Online Library
The approval process for antibody biosimilars relies primarily on comprehensive analytical
data to establish comparability and high similarity with the originator. Mass spectrometry …

Comparison of originator and biosimilar therapeutic monoclonal antibodies using comprehensive two-dimensional liquid chromatography coupled with time-of-flight …

M Sorensen, DC Harmes, DR Stoll, GO Staples… - MAbs, 2016 - Taylor & Francis
As research, development, and manufacturing of biosimilar protein therapeutics proliferates,
there is great interest in the continued development of a portfolio of complementary …

Rapid comparison of a candidate biosimilar to an innovator monoclonal antibody with advanced liquid chromatography and mass spectrometry technologies

H Xie, A Chakraborty, J Ahn, YQ Yu… - MAbs, 2010 - Taylor & Francis
This study shows that state-of-the-art liquid chromatography (LC) and mass spectrometry
(MS) can be used for rapid verification of identity and characterization of sequence variants …

Discovery and characterization of antibody variants using mass spectrometry-based comparative analysis for biosimilar candidates of monoclonal antibody drugs

W Li, B Yang, D Zhou, J Xu, Z Ke, WC Suen - Journal of Chromatography B, 2016 - Elsevier
Liquid chromatography mass spectrometry (LC–MS) is the most commonly used technique
for the characterization of antibody variants. MAb-X and mAb-Y are two approved IgG1 …

Analytical characterization of biosimilar antibodies and Fc-fusion proteins

A Beck, H Diemer, D Ayoub, F Debaene… - TrAC Trends in …, 2013 - Elsevier
Mass spectrometry (MS) is one of the key analytical techniques to detect and to identify
primary sequence differences, to assess similarity and to evaluate batch variability of …

Monoclonal antibodies biosimilarity assessment using transient isotachophoresis capillary zone electrophoresis-tandem mass spectrometry

R Gahoual, M Biacchi, J Chicher, L Kuhn, P Hammann… - MAbs, 2014 - Taylor & Francis
Out of all categories, monoclonal antibody (mAb) therapeutics attract the most interest due to
their strong therapeutic potency and specificity. Six of the 10 top-selling drugs are antibody …

Qualitative and quantitative characterization of protein biotherapeutics with liquid chromatography mass spectrometry

M Qu, B An, S Shen, M Zhang, X Shen… - Mass Spectrometry …, 2017 - Wiley Online Library
In the last decade, the advancement of liquid chromatography mass spectrometry (LC/MS)
techniques has enabled their broad application in protein characterization, both …

Integrating intact mass analysis and middle-down mass spectrometry approaches to effectively characterize trastuzumab and adalimumab structural heterogeneity

W Zhu, M Li, J Zhang - Journal of Proteome Research, 2020 - ACS Publications
Comprehensive characterization of therapeutic monoclonal antibody (mAb) structures is
critical for drug development but remains challenging due to the inherent structural …