Tools for the analysis and characterization of therapeutic protein species

A continuously increasing number of therapeutic proteins are being released into the market, including biosimilars. In contrast to small organic drugs, therapeutic proteins require an extensive analysis of their exact chemical composition because of their complexity and proof of the absence of conta...

Full description

Saved in:
Bibliographic Details
Published in:Biosimilars 2016-01, Vol.6, p.17
Main Authors: Fuh, Marceline Manka, Steffen, Pascal, Schluter, Hartmut
Format: Article
Language:English
Subjects:
Biological products
Biomarkers
Biopharmaceutics
Capillary electrophoresis
Chromatography
Enzymes
Health aspects
Identification
Immunoglobulins
Ions
Laboratories
Mass spectrometry
Pharmaceutical industry
Proteins
Proteomics
Scientific imaging
Citations: Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:A continuously increasing number of therapeutic proteins are being released into the market, including biosimilars. In contrast to small organic drugs, therapeutic proteins require an extensive analysis of their exact chemical composition because of their complexity and proof of the absence of contaminants, such as host cell proteins and nucleic acids. Especially challenging is the detection of low abundant species of therapeutic proteins because these species are usually very similar to the target therapeutic protein. However, the detection of these species is very important for the safety of patients because a very small change of the exact chemical composition may cause serious side effects. In this review, we give a brief overview about the most important analytical approaches for characterizing therapeutic protein species and their contaminants and focus on the progress in this field during the past 3 years. Top-down mass spectrometry of intact therapeutic proteins in the future may solve many of the current problems in their analysis.
ISSN:2230-245X
2230-245X
DOI:10.2147/BS.S68103