Title:N-glycan Analysis in Molecular Medicine: Innovator and Biosimilar Protein Therapeutics
VOLUME: 20 ISSUE: 10
Author(s):Beata Borza, Laszlo Hajba* and Andras Guttman
Affiliation:Horvath Csaba Memorial Institute of Bioanalytical Research, Research Institute of Biomolecular and Chemical Engineering, University of Pannonia, Horvath Csaba Memorial Institute of Bioanalytical Research, Research Institute of Biomolecular and Chemical Engineering, University of Pannonia, Horvath Csaba Memorial Institute of Bioanalytical Research, Research Institute of Biomolecular and Chemical Engineering, University of Pannonia
Keywords:Biosimilar, biosimilarity, biotherapeutics, glycosylation, antibody, analysis, capillary electrophoresis,
high performance liquid chromatography.
Abstract:The market segment of new biological drugs (monoclonal antibodies, fusion
proteins, antibody-drug conjugates, and new modality protein therapeutics) is rapidly
growing, especially after the patent expiration of the original biologics, initiating the
emergence of biosimilars. N-glycosylation of therapeutic proteins has high importance
on their stability, safety, immunogenicity, efficacy, and serum half-life. Therefore, Nglycosylation
is considered to be one of the critical quality attributes. Consequently, it
should be rigorously monitored during the development, manufacturing, and release of
glycoprotein biologicals. In this review, first, the regulatory considerations for biosimilars
are shortly summarized, followed by conferring the analytical techniques needed for
monitoring and characterization of the N-glycosylation of biological drugs. Particular
respect is paid to liquid phase separation techniques with high sensitivity and highresolution
detection methods, including laser-induced fluorescence and mass
spectrometry.
