Carbohydrate / Glycosylation Analysis Overview

  • Glycosylation is a dynamic, biologically active post-translational modification. Factors affecting glycosylation include the cell-line and bioreactor conditions, which may produce the same protein backbone with differences in overall structure, linkage and composition of glycans, potentially affecting bioactivity, safety and efficacy of the final product.

  • Characterisation of the glycan structure is important from early stage cell line selection right through development of the manufacturing process to consistency of final product.

  • The ICH Q6B Guidelines state:
     “For glycoproteins, the carbohydrate content (neutral sugars, amino sugars and sialic acids) is determined. In addition, the structure of the carbohydrate chains, the oligosaccharide pattern (antennary profile) and the glycosylation site(s) of the polypeptide chain is analysed, to the extent
    possible.”

ICH Q6B requires

SGS M-Scan provides

Monosaccharide Composition Analysis 

Glycan Population Analysis

Glycan Antennary Profiling Analysis

(including linkage analysis)

Glycosylation site analysis

 

SGS M-Scan's glycosylation analysis package is designed to encompass the requirements of the ICH guidelines. Individual analyses, or a full glycosylation analysis package are available to GLP / cGMP together with advice from recognised SGS M-Scan glycan experts.