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Carbohydrate analysis throughout the development of a protein therapeutic.

Higgins E - Glycoconj. J. (2009)

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: GlycoSolutions Corporation, One Innovation Dr., Suite 115, Worcester, MA 01605, USA. liz@glycosolutions.com

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.

Show MeSH
An imaginary complex N-linked oligosaccharide demonstrating modifications that can occur on these oligosaccharide structures.  is GlcNAc;  is galactose;  is mannose,  is fucose and  is sialic acid
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Fig1: An imaginary complex N-linked oligosaccharide demonstrating modifications that can occur on these oligosaccharide structures. is GlcNAc; is galactose; is mannose, is fucose and is sialic acid

Mentions: This review will cover N-linked glycosylation (where glycans are attached to asparagine residues in the peptide sequence, sees Figs. 1 and 2) and mucin-type O-linked glycosylation (where GalNAc is attached to serine/threonine residues and then additional monosaccharides may be added to the GalNAc, see Fig. 3). Other types of glycosylation are reviewed by Vliegenthart [56] and Spiro [57].Fig. 1


Carbohydrate analysis throughout the development of a protein therapeutic.

Higgins E - Glycoconj. J. (2009)

An imaginary complex N-linked oligosaccharide demonstrating modifications that can occur on these oligosaccharide structures.  is GlcNAc;  is galactose;  is mannose,  is fucose and  is sialic acid
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2821524&req=5

Fig1: An imaginary complex N-linked oligosaccharide demonstrating modifications that can occur on these oligosaccharide structures. is GlcNAc; is galactose; is mannose, is fucose and is sialic acid
Mentions: This review will cover N-linked glycosylation (where glycans are attached to asparagine residues in the peptide sequence, sees Figs. 1 and 2) and mucin-type O-linked glycosylation (where GalNAc is attached to serine/threonine residues and then additional monosaccharides may be added to the GalNAc, see Fig. 3). Other types of glycosylation are reviewed by Vliegenthart [56] and Spiro [57].Fig. 1

Bottom Line: 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.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.

View Article: PubMed Central - PubMed

Affiliation: GlycoSolutions Corporation, One Innovation Dr., Suite 115, Worcester, MA 01605, USA. liz@glycosolutions.com

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.

Show MeSH