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N-glycans are omnipresent in the Fc region of monoclonal antibody products. Modifications to a glycan profile can impact a protein’s stability/folding, binding affinities, effector functions, clearance rates, and/or immunogenicity. Their characterization is critical to ensuring efficacy and safety in patients. The multitude of glycan characterization methods, each with different levels of sensitivity and reliability, complicates standardization efforts. To tackle this, we’ve conducted comparative glycan analysis studies, examining various innovator mAbs, their biosimilars, and different characterization techniques for NIST mAb.
This session was recorded in February 2024.