Antibodies and proteins such as monoclonal antibodies, bispecific antibodies, anti-idiotype antibodies, antibody-drug conjugates, enzymes, cytokines, membrane proteins, etc. have been the main research targets for therapeutics. Thus, it's required to fully understand their structural and functional properties by means of biochemical, biophysical, and biological characterization, especially in the later stages of drug development. Several techniques have been developed for the structure and biochemical characterization of therapeutic biomolecules, which are suitable for analyzing the primary structure, functions, stability, sizes, charge heterogeneity, purity, and potency of the target biological agents.

This review includes some innovative and trending techniques for characterizing the structure and biochemical properties of antibody and protein drugs. Sections are listed as shown in the following:

1. Primary Structure Characterization—For primary sequence confirmation, N- and C-terminal variant descriptions, and disulfide description.
2. Biophysical Characterization—For analysis of structure, function, and stability of biological macromolecules.
3. Forced Degradation Studies
4. Charge Variant Analysis—For protein charge heterogeneity assessment
5. Manufacturability Assessment—For analysis of productivity, process yield, stability, etc.