In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity AnalysisNohemi Salinas-Jazmín 1,2, Edith González-González 1, Luz X. Vásquez-Bochm 3, Sonia M. Pérez-Tapia 4,5, Marco A. Velasco-Velázquez 6
1Unit for Development and Research in Bioprocesses Unit (UDIBI), National School of Biological Sciences, National Polytechnic Institute (IPN), University of Mexico (UNAM), 2School of Chemistry, National Autonomous University of Mexico (UNAM), 3Graduate Program in Chemical Sciences, National Autonomous University of Mexico (UNAM), 4Unit for Development Research and Medical Innovation in Biotechnology (UDIMEB), National School of Biological Sciences, National Polytechnic Institute (IPN), 5Department of Immunology, National Scool of Biological Sciences, National Polytechnic Institute (IPN), 6Department of Pharmacology and Unit of Translational Biomedicine (CMN 20 de noviembre), School of Medicine, National Autonomous University of Mexico (UNAM)
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.
