The unique feature of bispecific antibodies (BsAbs) is that they combine at least two antigen-binding elements from different antibodies within a single molecule. A variety of different ways exist, to unify the properties of multiple antibodies in one BsAb, making the evaluation and characterization of critical quality attributes (CQAs) for these subclasses particularly sensitive. In this regard, our experienced experts place special emphasis on compliance with all relevant CQAs.

Biofidus provides a broad range of state-of-the-art analytical techniques to support your biologics development or biosimilar comparability study. We cover the structural as well as the functional characterization of proteins allowing us to provide you with a complete analytical package for your analytical challenge.

Our analytical portfolio includes in-depth analysis of the protein primary structure, amino acid modifications, impurities like homodimers as well as  binding or functionality in cell-based assays. We are specialists in determining protein glycosylation structures, which are among the most important protein modifications that can have significant influence on function and stability of biopharmaceutical molecules.

Our vast experience and deep knowledge in this field allows us to guide you through the variety of available methods and help you find the optimal analytical solution for your project.

In accordance with your needs, we adapt and, if required, qualify (according to ICH guidelines) our platform methods tailored to your drug substance (DS), its individual formulation matrix and your distinct analytical question.

Get in contact with us to quickly find the optimal setup for your analytical challenge and to speak directly from expert to expert.