In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis

作者： Nohemi Salinas-Jazmín1,2, Edith González-González1, Luz X. Vásquez-Bochm3, Sonia M. Pérez-Tapia4,5, Marco A. Velasco-Velázquez6 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)

简介：

Overview

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.

Key Study Components

Area of Science

• Immunology
• Pharmacology
• Biosimilars

Background

• Rituximab is a monoclonal antibody used in the treatment of various B-cell malignancies.
• Biosimilars are biologic medical products highly similar to already approved reference products.
• Understanding the functional characteristics of biosimilars is crucial for their development.
• Complement-dependent cytotoxicity (CDC) is an important mechanism of action for rituximab.

Purpose of Study

• To compare the target binding of reference rituximab and its biosimilar.
• To evaluate the CDC induction capabilities of both products.
• To provide a protocol that can be used in biosimilar development and quality control.

Methods Used

• In vitro assays for target binding assessment.
• Complement-dependent cytotoxicity assays.
• Side-to-side comparison methodology.
• Quality control measures during biosimilar production.

Main Results

• Both rituximab and its biosimilar demonstrated comparable target binding.
• CDC induction was effectively measured for both products.
• The results support the use of these assays in biosimilar development.
• Quality control protocols were established for future applications.

Conclusions

• The study confirms the functional similarity between reference rituximab and its biosimilar.
• Assays developed can be utilized for ongoing biosimilar evaluations.
• Further research may expand on these findings to ensure biosimilar efficacy.

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