Molecular and functional analysis of monoclonal antibodies in support of biologics development

摘要: Monoclonal antibody (mAb)-based therapeutics are playing an increasingly important role in the treatment or prevention of many diseases such as cancers, autoimmune disorders, and infectious diseases. Multi-domain mAbs far more complex than small molecule drugs with intrinsic heterogeneities. The critical quality attributes a given mAb, including structure, post-translational modifications, functions at biomolecular cellular levels, need to be defined profiled details during developmental phases biologics. These attributes, outlined this review, serve database for defining drug properties commercial production phase well post licensure life cycle management. Specially, molecular characterization, functional assessment, effector function analysis mAbs, reviewed respect parameters methods used obtaining them. three groups analytical essential integral facets making up whole package mAb-based drug. Such is critically post-licensure management therapeutic prophylactic In addition, basic principles on evaluation biosimilar were discussed briefly based recommendations by World Health Organization.