Glycoproteomics Technologies in Glycobiotechnology.

Area of Science:

• Biochemistry
• Analytical Chemistry
• Pharmacology

Background:

• Glycosylation significantly impacts biotherapeutic properties like stability, solubility, pharmacokinetics, and immunogenicity.
• Accurate glycosylation characterization is essential for demonstrating biotherapeutic similarity and meeting regulatory requirements for biosimilars.
• Mass spectrometry (MS) has become indispensable for analyzing glycosylation-related critical quality attributes (CQAs).

Purpose of the Study:

• To provide an overview of MS-based technologies for biotherapeutic characterization.
• To highlight recent advancements in MS for detailed glycosylation analysis.
• To emphasize the importance of glycosylation profiling for biosimilar development and quality control.

Main Methods:

• Review of mass spectrometry (MS) based technologies.
• Focus on recent MS developments for glycan analysis.
• Discussion of techniques for determining glycosylation site, sialic acid linkage, glycan structure, and content.

Main Results:

• MS technologies enable comprehensive characterization of glycosylation CQAs.
• Recent advancements allow for detailed determination of glycan structures, sites of attachment, and linkage isomers.
• MS-based approaches are critical for quality control and comparability assessments of biotherapeutics.

Conclusions:

• Advanced MS techniques are vital for the thorough characterization of biotherapeutic glycosylation.
• Detailed glycosylation profiling using MS is necessary for regulatory approval of biosimilars.
• Continued innovation in MS will further enhance the ability to characterize complex biotherapeutics.