Abstract
This chapter will focus on the importance of the physicochemical characterization of monoclonal antibodies for in-process sampling, lot release, stability testing and analytical comparability assessment in R&D and manufacturing departments in biopharmaceutical companies. In addition, this chapter will provide an overview of each of the quality attributes including the critical quality attributes that may impact immunogenicity/safety, biological activity/efficacy, clearance (pharmacokinetics and pharmacodynamics) and overall structure and function monoclonal antibodies. The quality attributes that will be discussed in detail include glycan heterogeneity, size heterogeneity, charge heterogeneity, identity via peptide mapping and higher order structure. The analytical methodology for assessing the attributes and key parameters to be taken into consideration during method development will also be presented.
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