N-link glycan analysis by HPLC
N-Link Glycan Analysis by HPLC
Analysis of the N-linked glycan structures of glycoproteins determines their glycan type and abundance.
· Glycan antennary: 1-antennary, 2-Antennary, 3-antennary and 4-antennary
· Fucose residues, antennary fucose or core fucose.
· Sialic acids distribution
· Glycan termini residues: N-acetyl-galactoseamine (GalNAc) and bisecting N-acetyl-glucosamine (GlcNAc), and the antigenic structure alpha 1-3 galactose
· High mannose and hybrid structures
N-linked glycan analysis is applicable to all stages of biopharmaceutical development and manufacturing processes including cell line and clone selection, upstream and downstream process development, manufacturing in-process control, batch consistency and release.
N-linked glycan analysis is required by ICH Q6B guidelines for biopharmaceutical characterization.
In order to obtain full structural analysis, enzyme array of exoglycosidases is applied to the labeled glycans, followed by re-separation on the NP column. The peaks are verified according to their retention time using in-house-characterized standard database.
In addition, for sialic acid quantitation, N-linked glycan charge distribution is determined by HPLC separation of the 2AB labeled glycans using Weak Anion Exchange (WAX) column.
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