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Label-free interaction analysis as a tool to demonstrate biosimilarity of therapeutic monoclonal antibodies

Authors Sinha-Datta U, Khan S, Wadgaonkar D

Received 27 March 2015

Accepted for publication 12 June 2015

Published 16 September 2015 Volume 2015:5 Pages 83—91

DOI https://doi.org/10.2147/BS.S85537

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Shein-Chung Chow


Uma Sinha-Datta, Srijit Khan, Dhananjay Wadgaonkar

Fast Trak, GE Healthcare Life Science, John F Welch Technology Centre, Bangalore, India

Abstract: In the biosimilar eon, where various analytical platforms are needed to show biosimilarity, we demonstrate the use of surface plasmon resonance biosensor as a label-free interaction analysis tool to compare two therapeutic monoclonal antibodies (mAb1-i and mAb2-i) with their biosimilars (mAb1-B and mAb2-B1, B2, B3) based on kinetics, affinity, and thermal stability studies. We calculate active analyte concentration using Biacore systems' calibration-free concentration analysis method and demonstrate its importance for kinetic evaluation. The kinetic constants (ka and kd) and affinity constant (KD) of the mAbs for binding to specific antigens were evaluated. It was found that the biosimilars were very similar to their innovator with respect to binding to its antigen demonstrating functional similarity. To further confirm biosimilarity to the originator molecules, we conducted a thermal stability analysis of both mAbs using differential scanning calorimetry. This analysis showed good structural similarity in between innovator antibodies and biosimilars, with major Tm as 84.1°C (mAb1) and 72.8°C (mAb2), demonstrating structural similarity.

Keywords: surface plasmon resonance, Biacore, kinetics, low level of ligand immobilization, calibration-free concentration analysis, bivalent analytes, active concentration

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