Capillary electrophoresis methods are widely used in the biopharmaceutical industry to detect product variants and product-related impurities because they provide sensitive, high-resolution measurements of size and charge heterogeneity. The peaks observed by these methods are often highly important, since the underlying species can affect product quality, biological activity, stability, pharmacokinetics, immunogenicity, and direct decisions regarding control strategies.
The analytical challenge is that capillary electrophoresis does not itself provide structural or functional characterization of the species represented by these peaks. Instead, the detected peaks must be characterized by additional studies. This is often difficult because the species of interest are present at very low levels, may be only partially resolved, and may require multiple orthogonal methods to establish identity and biological function.
As a result, characterization is often indirect. The CE method detects the change, but structural and functional assignment typically relies on complementary experiments, enrichment or fractionation approaches, altered sample treatment, and integration of evidence across methods. This presentation will discuss practical approaches for characterizing product variants and product-related impurities detected by CE-SDS, icIEF, and CZE, with brief attention to newly observed peaks in QC and investigation settings.
Learning Objectives:
Upon completion, participants will be able to define product variants, product-related impurities, and process-related impurities within the context of a biopharmaceutical analytical control strategy.
Upon completion, participants will be able to explain how structure–function relationships and orthogonal analytical approaches support classification of capillary electrophoresis-detected species.
Upon completion, participants will be able to describe the principles of capillary electrophoresis and identify factors that make characterization of capillary electrophoresis peaks uniquely challenging.
Upon completion, participants will be able to evaluate analytical strategies for characterizing product variants and product-related impurities detected by capillary electrophoresis.
Upon completion, participants will be able to discuss emerging technologies and approaches that strengthen structure–function understanding and improve characterization workflows for biopharmaceutical development.
