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Cell-Based Assays Keep Biosimilars on Track

The cell-based assay has become a mainstay of drug development, addressing new concerns raised by the advent of biologics. These concerns include the difficulties inherent in characterizing drug efficacy and patient safety in the context of immunogenicity. Whereas small molecule drugs may escape detection by the immune system, larger protein therapeutics, such as monoclonal antibodies, are apt to trigger alarms.

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