ABSTRACT
The biotechnology industry is enjoying robust growth that is fueled by opportunities of biologics drugs in unmet medical-need areas including cancer and immunology. This chapter discusses the proteins that encompass the majority of biotherapeutics; however the concepts for biophysical and biochemical characterization remain the same regardless of the class of molecular entity. Biophysical characterization of therapeutic candidates in drug discovery is critical to selection and optimization of protein molecules that have the desired biological activity, and to ensure developability of drug candidates that can be efficiently developed and manufactured. Mass spectrometry is a powerful tool for confirmation of the primary structure of proteins and peptides. Peptide mapping is a very selective method for the confirmation of identity. Charge profiling is a common method for the determination of the relative amount of charged, or sialic acid containing, glycans.
