Monoclonal antibody (mAb)-based therapeutics are playing\nan increasingly important role in the treatment or prevention\nof many important diseases such as cancers,\nautoimmune disorders, and infectious diseases. Multidomain\nmAbs are far more complex than small molecule\ndrugs with intrinsic heterogeneities. The critical quality\nattributes of a given mAb, including structure, post-translational\nmodifications, and functions at biomolecular and\ncellular levels, need to be defined and profiled in details\nduring the developmental phases of a biologics. These\ncritical quality attributes, outlined in this review, serve an\nimportant database for defining the drug properties during\ncommercial production phase aswell as post licensure life\ncycle management. Specially, the molecular characterization,\nfunctional assessment, and effector function analysis\nof mAbs, are reviewed with respect to the critical parameters\nand the methods used for obtaining them. The three\ngroups of analytical methods are three essential and integral\nfacets making up the whole analytical package for a\nmAb-based drug.Such a package is critically important for\nthe licensure andthepost-licensure lifecyclemanagement\nof a therapeutic or prophylactic biologics. In addition, the\nbasic principles on the evaluation of biosimilarmAbswere\ndiscussed briefly based on the recommendations by the\nWorld Health Organization.
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