title: Carbohydrate analysis throughout the development of a protein therapeutic.
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.
authors.affiliation: GlycoSolutions Corporation, One Innovation Dr., Suite 115, Worcester, MA 01605, USA. liz@glycosolutions.com
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Higgins
mesh_terms: D000818:Animals; D002241:Carbohydrates / Q000032:analysis* / Q000737:chemistry; D006023:Glycoproteins / Q000627:therapeutic use*; D006031:Glycosylation; D006801:Humans; D019158:N-Acetylneuraminic Acid / Q000378:metabolism; D009844:Oligosaccharides / Q000737:chemistry
chemical_list: D002241:Carbohydrates; D006023:Glycoproteins; D009844:Oligosaccharides; D019158:N-Acetylneuraminic Acid