Regeneron Pharmaceuticals, Inc.
CHARACTERIZATION OF DOMAIN-SPECIFIC CHARGE VARIANTS OF ANTIBODIES

Abstract:

The present invention provides methods and systems for analyzing the biophysical characteristics of peptides or proteins, such as antibodies, based on enzymatic digestion-assisted imaged capillary electrophoresis (DiCE) to characterize the domain-specific charge variants, preferably within a bispecific antibody. The methods and systems include treating the protein with digestion enzymes to generate components of the protein, reducing or denaturing the components, and separating the components based on their isoelectric points.