Bispecific & Multispecific Antibody Characterization
Multispecific and bispecific antibodies (MsAbs / bsAbs) combine two or more antigen-binding specificities within a single molecule, enabling advanced mechanisms such as T-cell engagement, dual checkpoint blockade or receptor clustering. The wide variety of formats (e.g. IgG-like, Fc-less, knob-into-hole, CrossMab, tandem scFv) makes evaluation and characterization of critical quality attributes (CQAs) particularly sensitive and complex. Correct chain pairing, stoichiometry, format integrity and balanced binding to all targets are essential for efficacy, safety and manufacturability, and require dedicated multispecific antibody characterization strategies.
At Biofidus, we offer a broad, state-of-the-art analytical platform for multispecific and bispecific antibodies to support innovator biologics development as well as biosimilar comparability studies.
We cover structural and functional characterization, including in-depth primary structure and sequence confirmation, amino acid and post-translational modifications, impurities such as homodimers or mispaired species, and target-relevant functionality in cell-based assays.
We are specialists in antibody glycosylation analysis, a key modification with strong impact on function, stability and immunogenicity of biopharmaceutical molecules. Our extensive experience allows us to guide you through the available methods and define the optimal, ICH-aligned analytical strategy for your MsAb / bsAb project.
We adapt our platform methods to the properties of your drug substance, its individual formulation matrix, and your specific analytical question, and qualify them as needed according to ICH guidelines.
Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.
