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Millipore Technical Publications


AN4475EN00_EM.pdfAN4475EN00_EM.pdf
AN- AN4475EN00

Effective In Vitro Bioanalytical Assays for Comparing Pharmacodynamics of Biosimilar Monoclonal Antibodies

Lit No:AN4475EN00
Year:2012



Abstract

The rise in the development of biosimilar therapeutics has caused increasing demand for new approaches for precise, sensitive, accurate bioanalysis. In this white paper, we describe how a combination of the biopharmaceutical market, regulatory guidelines and the molecular characteristics of biologics has inspired the development of novel ligand-binding assays (specifically, flow cytometry and surface plasmon resonance) that may streamline evaluation of biosimilars.

Click the PDF above for the full document.