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.

journal_name

Glycoconj J

journal_title

Glycoconjugate journal

authors

Higgins E

doi

10.1007/s10719-009-9261-x

subject

Has Abstract

pub_date

2010-02-01 00:00:00

pages

211-25

issue

2

eissn

0282-0080

issn

1573-4986

journal_volume

27

pub_type

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