Comparison of enriched charge variants from different anti-CD3 bispecific antibodies reveals differential susceptibility of each bispecific arm to post-translational modification.

ABSTRACT: Charge heterogeneity is an important quality attribute of therapeutic antibodies, and a detailed understanding of charge heterogeneity arising from post-translational modifications (PTMs) is required by regulatory agencies during drug development. Among antibody therapeutics, the bispecific antibody with two distinct Fab domains targeting distinct antigens provides additional complexity to the charge profile. In this study, charge variant species were enriched from three bispecific antibodies (bsAbs) each containing one anti-CD3 binding arm designed with differential affinity to CD3. The charge heterogeneity corresponding to each anti-CD3 arm within each enriched fraction was evaluated using a domain-specific, digestion-assisted imaged capillary isoelectric focusing (icIEF) method known as

SUBMITTER: Nguyen JB 

PROVIDER: S-EPMC11926628 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature