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Review
. 2010 Feb;27(2):211-25.
doi: 10.1007/s10719-009-9261-x. Epub 2009 Nov 4.

Carbohydrate analysis throughout the development of a protein therapeutic

Elizabeth Higgins  1
Affiliations
Review

Carbohydrate analysis throughout the development of a protein therapeutic

Elizabeth Higgins. Glycoconj J. 2010 Feb.

Abstract

This review discusses the challenges involved in the characterization of the glycosylation of therapeutic glycoproteins. The focus is on methods that are most commonly used in regulatory filings and lot release testing of therapeutic glycoproteins. The different types of assays for carbohydrate analysis are reviewed, including the distinction between assays appropriate for lot release or better suited to testing during early drug development or in-depth characterization of the glycosylation. Characteristics of the glycoprotein and production process that should be considered when determining the amount of testing, the number of different methods to employ and when the testing should be performed during development of protein therapeutics is also discussed.

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Figures

Fig. 1
Fig. 1
An imaginary complex N-linked oligosaccharide demonstrating modifications that can occur on these oligosaccharide structures. formula image is GlcNAc; formula image is galactose; formula image is mannose, formula image is fucose and formula image is sialic acid
Fig. 2
Fig. 2
Oligomannose and hybrid oligosaccharide structures. formula image is GlcNAc; formula image is galactose; formula image is mannose and P is phosphate
Fig. 3
Fig. 3
O-linked oligosaccharide core structures. These structures can be extended, much like N-linked oligosaccharides. formula image is GlcNAc; formula image is galactose and formula image is GalNAc
See this image and copyright information in PMC

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