The overall goal of this procedure is to compare two key functional characteristics between therapeutic antibodies, target binding, and CDC induction during their biosimilar development, or as a quality control, during their production.These methods can help answer our key questions about how to assess functional differences between therapeutic antibodies that bind the same target protein.These techniques are quick, simple, and inexpensive, allowing for day execution in most laboratories.Demonstrating the procedures will be Edith Gonz
Summary
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This protocol describes the in vitro comparison of two key functional characteristics of rituximab: target binding and complement-dependent cytotoxicity (CDC) induction. The methods were employed for a side-to-side comparison between reference rituximab and a rituximab biosimilar. These assays can be employed during biosimilar development or as a quality control in their production.
Salinas-Jazmín, N., González-González, E., Vásquez-Bochm, L. X., Pérez-Tapia, S. M., Velasco-Velázquez, M. A. In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis. J. Vis. Exp. (123), e55542, doi:10.3791/55542 (2017).