Abstract

TO DETERMINE CHARGE VARIANTS BY ION EXCHANGE CHROMATOGRAPHY IN THERAPEUTIC MONOCLONAL ANTIBODY

Pooja Bharti*, Dharmendra Mishra, Ankit Tiwari, Afsana Begam, Ferjana Khan, SP. Shukla, Mohammad Zishan, Altamash Khan, Noorul Huda and Sameena Malik

ABSTRACT

Numerous putative post-translational modifications may induce variations of monoclonal antibodies charge distribution that can potentially affect their biological activity. The characterization and the monitoring of these charge variants are critical quality requirements to ensure stability and process consistency. Charge variants are usually characterized by preparative ion exchange chromatography, collection of fractions and subsequent reverse-phase liquid chromatography with mass spectrometry analysis. While this process can be automatized by on-line two-dimensional chromatography, it remains often complex and time consuming. For this reason, a straightforward on-line charge variant analysis method is highly desirable and analytical laboratories are actively pursuing efforts to overcome this challenge.

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