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

Journal of Pharmaceutical and Biomedical Analysis
Ryosuke KuribayashiNana Kawasaki

Abstract

The development of therapeutic antibodies has grown over the last several years. Most of the recombinant monoclonal antibodies (mAbs) produced by mammalian cells are glycoproteins. Glycosylation of the mAbs can be associated with effector functions, such as antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity, as well as immunogenicity and clearance. Thus, mAb glycan heterogeneity is a significant characteristic associated with the safety and efficacy of the products. Therefore, glycan heterogeneity should be evaluated during research and development (R&D) and during development of mAbs manufacturing processes to identify the process parameters that affect glycan heterogeneity and to enhance understanding of the manufacturing process. There is an increasing need for a rapid, easy, and automated evaluation method for glycan heterogeneity. Liquid chromatography/mass spectrometry (LC/MS) is a method that can be used to analyze glycoforms. LC/MS is marked by the ability to measure the oligosaccharide composition of each glycoform, whereas other general methods, such as capillary electrophoresis, sodium dodecyl sulfate-polyacrylamide gel electrophoresis, and ion-exchange chromatography, cannot. However, a l...Continue Reading

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Citations

Nov 28, 2012·Trends in Biotechnology·Abhinav A Shukla, Uwe Gottschalk
Mar 10, 2015·Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan·Kenichiro Todoroki
Aug 15, 2014·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Yinan ChenYingyan Yu
May 28, 2013·Journal of Pharmaceutical and Biomedical Analysis·Akira HarazonoNana Kawasaki
Mar 17, 2015·Journal of Pharmaceutical and Biomedical Analysis·Hongbin LiuYonghua Taylor Zhang
Jun 22, 2016·Journal of Pharmaceutical and Biomedical Analysis·Maria Kristina ParrHouda Montacir
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Nov 9, 2012·Analytical Chemistry·Alain BeckSarah Sanglier-Cianférani

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