The commercial success of therapeutic monoclonal antibodies has led to a great expansion in the number of mAbs in clinical development.  There has been a steady upward trend in the number of New Biological Entity INDs submitted to the FDA in the past 10 years including novel constructs such as antibody conjugates, bispecific mAbs and antibody fragments. More recently, biosimilar mAbs are under development.  During this period, much has been learned about critical quality attributes that impact effector function, pharmacokinetics and immunogenicity of mAbs.  This talk will focus on the regulatory perspective and challenges regarding the characterization of quality attributes for novel and biosimilar therapeutic monoclonal antibodies.

Regulatory perspectives on the characterization of therapeutic monoclonal antibody quality attributes

248th National Meeting (2014)

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