Rapid biotherapeutic charge variant analysis by CZE-UV and CZE-MS

There is a vital need to characterize Biopharmaceuticals in early phase screening to ensure the most suitable candidates are accelerated through the development funnel. Charge variants and amino acid sequence variants are critical quality attributes (CQAs) which need to be characterized and controlled quickly during screening and process development.

 

Rapid charge variant analysis is performed by gold standard CZE and cIEF capillary electrophoresis methods with optical detection. However, identification of unknown charge variant peaks remains a challenge without complex workflows involving fraction collection. The work presented here demonstrates that CE-MS profiles near identical to those from CZE and cIEF allows identification of unknown charge variant peaks in under 10 minutes.

 

What you will learn: