Unlock Binding Affinity Insights Through Charge Heterogeneity Analysis of Biotherapeutic Molecules

A Novel icIEF Fractionation & Surface Plasmon Resonance Workflow

Countless studies on the charge heterogeneity of biotherapeutics report some variation of the statement "charge heterogeneity can have potential impacts on drug stability, efficacy, and potency." Charge heterogeneity has therefore become a Critical Quality Attribute (CQA) of biotherapeutic molecules, and a combination of assays is required to ascertain the impact of such variants on the product quality.

In this study, we present a novel approach for determining the impact of charge heterogeneity on the binding kinetics and affinity of biotherapeutics. Using the bispecific antibody Mosunetuzumab and a biosimilar as models, the study combines imaged capillary isoelectric focusing (icIEF) on the MauriceFlex™ system with low-volume, high-throughput binding studies on the Alto™ Digital SPR System (Nicoya Lifesciences). This workflow enables efficient isolation and detailed characterization of individual charge variants, offering a novel solution to traditional challenges in charge variant analysis.

Workflow Benefits

It is a fast, accurate, and scalable method to connect charge heterogeneity with binding potency. By identifying charge species that impact binding affinity, this method can enhance process development and manufacturing control, thus supporting higher-quality therapeutic production.

For biotherapeutic developers seeking reliable methods to characterize charge variants and their impact on functionality, this workflow demonstrates the MauriceFlex and Alto systems as a robust solution. Dive deeper into this study's findings and learn how these insights can support the development of next-generation biologics.