Enzymes for In-Depth Antibody Characterization

Therapeutic antibodies used as biopharmaceuticals are highly complex molecules requiring strict monitoring and control during manufacturing. Due to its nature as a biological drug, drug safety and innate variation in production methods is always a cause for concern. Thus, a series of workflows for comprehensive, in-depth analytical characterization should be applied to analyze and characterize product quality.

With the approval of monoclonal antibody products dramatically increasing each year such as mAbs, Fc-fusions, Fab, antibody-drug conjugates, bispecific mAbs (bsAbs) and bispecific T cell engagers (BiTE), understanding individual post-translational modifications (PTMs) can give a better insight and prediction as to the in vivo efficacy, pharmacokinetics, and mechanism of action of manufactured Abs.

Characterization of Abs is usually performed in several perspectives, starting from top-down analysis (overall structure) to bottom-up analysis (peptide sequencing), and finally, middle-level analysis (Fc, Fv, PTMs).

To enable antibody characterization methods, ACROBiosystems has developed a series of enzymes to assist with the characterization of antibodies and their related PTMs.

The structure and type of N-linked glycans can affect the immunogenicity, pharmacokinetics, and pharmacodynamics of therapeutic proteins such as monoclonal antibodies (mAbs) and Fc fusion proteins. Enzymes such as Endo H and Endo S provide type-specific cleavages of N-linked glycans for subsequent analysis.