Characterization of Pharmaceutical IgG and Biosimilars Using Miniaturized Platforms and LC-MS/MS

Overview

Journal Curr Pharm Biotechnol

Publisher Bentham Science Publishers

Specialties Biotechnology
Pharmacology

Date 2016 Apr 2

PMID 27033511

Citations 13

Authors

Kerry M Wooding

Wenjing Peng

Yehia Mechref

Affiliations

Soon will be listed here.

Abstract

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 response from the immune system to destroy the cell. As originator mAb drug patents are coming to an end, generic pharmaceutical companies are poised to replicate and produce so-called biosimilar drugs. MAbs are significantly more complicated than small drugs to analyze and produce. The mAb proteoform and glycoform must be as similar to the original drug as possible to be a viable replacement. The mAb proteoform is well characterized but can be altered through various undesirable reactions such as deamidation. The mAb glycoform is harder to replicate as the glycan formation is a complicated templateless one; it is proving difficult for the originator companies to produce a homogenous population of mAbs from batch to batch. Severe side-effects have occurred in patients taking mAbs with immunogenic glycans, highlighting the importance of quality control mechanisms. The complex nature of mAbs requires sensitive and robust tools amenable to the highthroughput analysis required by a manufacturing setting. Miniaturized analytical platforms for complex biosimilar analysis are still in their infancy but have shown great promise for sample preparation. Capillary electrophoresis-laser induced fluorescence remains a powerful and fast technique for routine glycan analysis. Mass spectrometry is the method of choice for the analysis of mAb proteoforms and is emerging as a powerful tool for glycoform analysis.

Citing Articles

Analysis of Native and Permethylated N-Glycan Isomers Using MGC-LC-MS Techniques.

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Glycomic and Glycoproteomic Techniques in Neurodegenerative Disorders and Neurotrauma: Towards Personalized Markers.

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Separation of Permethylated -Glycans, Free Oligosaccharides, and Glycosphingolipid-Glycans Using Porous Graphitized Carbon (PGC) Column.

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Integrated Transcriptomics, Proteomics, and Glycomics Reveals the Association between Up-regulation of Sialylated N-glycans/Integrin and Breast Cancer Brain Metastasis.

Peng W, Zhu R, Zhou S, Mirzaei P, Mechref Y Sci Rep. 2019; 9(1):17361.

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