Charge Variant analysis of mAb Biosimilars by Nexera UHPLC with a Shim-pack Bio IEX Column

The characterization and monitoring of charge variants of mAb biosimilars are critical quality requirements to ensure the stability and process consistency in drug development. Conventionally, ion exchange chromatography (IEX) with salt-gradient is the gold standard method for charge-sensitive antibody analysis. A key challenge of salt-gradient is that the method parameters often need to be optimized for each individual protein. In 2009, Genentech first reported the use of IEX with pH-gradient for mAb charge variant separations. It was found that mAbs with isoelectric points in the range of pH 7-9 could be well separated. Moreover, the approach was more generic and could easily be used to separate different charge variants in a wide range of antibodies.
In this study, we describe both salt-gradient and pHgradiet methods for separating the charge variants of bevacizumab biosimilar using Shimadzu Nexera UHPLC and a Shim-pack Bio IEX column (4.6 mm x100 mm, 3 μm).

Content Type:
Application
Document Number:
AD-0195
Product Type:
Liquid Chromatography
Keywords:
Monoclonal antibod (mAb), Biosimilar, Bevacizumab, Shim-pack Bio IEX, Pharmaceutical, Life Science, Manufacturing, QA/QC, Nexera-i UHPLC, Nexera Bio UHPLC
Language:
English
File Name:
apl219037.pdf
File Size:
192kb

Free Download

For Research Use Only. Not for use in diagnostic procedures.

This page may contain references to products that are not available in your country. Please contact us to check the availability of these products in your country.

Top of This Page