Characterization of pharmaceutical IgG and biosimilars using miniaturized platforms and LC-MS/MS

KM Wooding, W Peng… - Current pharmaceutical …, 2016 - ingentaconnect.com
Therapeutic monoclonal antibodies (mAbs) have made a tremendous impact in treating
patients with various diseases. MAbs are designed to specifically target a cell and illicit a …

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 …

Bioanalytical tools for the characterization of biologics and biosimilars

A Guttman, AS Rathore, IS Krull - LC-GC North America, 2012 - go.gale.com
One of the fastest growing segments in the biopharmaceutical market is biosimilars. This
emerging biotech sector requires novel bioanalytical tools to address the challenging …

Special issue on therapeutic antibodies and biopharmaceuticals

J Chung - Experimental & molecular medicine, 2017 - nature.com
Currently, there are more than 58 antibodies clinically available for the treatment of various
diseases, including cancer, chronic inflammation and infection. In 2016, eight antibodies …

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 …

[图书][B] Biosimilars of monoclonal antibodies: a practical guide to manufacturing, preclinical, and clinical development

C Liu, KJ Morrow Jr - 2016 - books.google.com
Addressing a significant need by describing the science and process involved to develop
biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar …

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 …

Molecular and functional analysis of monoclonal antibodies in support of biologics development

X Wang, Z An, W Luo, N Xia, Q Zhao - Protein & cell, 2018 - academic.oup.com
Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in
the treatment or prevention of many important diseases such as cancers, autoimmune …

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 …

Rapid evaluation for heterogeneities in monoclonal antibodies by liquid chromatography/mass spectrometry with a column-switching system

R Kuribayashi, N Hashii, A Harazono… - Journal of pharmaceutical …, 2012 - Elsevier
The development of therapeutic antibodies has grown over the last several years. Most of
the recombinant monoclonal antibodies (mAbs) produced by mammalian cells are …