Overcoming Complex Analytical Challenges Posed by Targeted Multispecific Antibody Cancer Therapeutics

Complex multispecific antibodies overcome the limitations of standard monoclonal antibodies (mAbs), and have complex three-dimensional structures, greater heterogeneity, and often novel disulfide linkages and unusual post-translational modifications. As a result, the comprehensive characterization essential to the development of cost-effective manufacturing processes and safe and efficacious cancer treatments is much more challenging using traditional analytical instruments and techniques. Fortunately, there are new solutions available that provide fast results, often with greater sensitivity and resolution, even for these novel, complex molecules. The application of various new methods and instruments for the analysis of multispecifics is discussed as a means of highlighting their ability to facilitate the development of these important new modalities.