1. Industry and regulatory experience of the glycosylation of monoclonal antibodies.
- Author
-
Read EK, Park JT, and Brorson KA
- Subjects
- Animals, Antibodies, Monoclonal biosynthesis, Antibodies, Monoclonal therapeutic use, CHO Cells, Cricetinae, Cricetulus, Databases, Protein, Drug Approval, Electrophoresis, Capillary methods, Glycosylation, Humans, Licensure, Mass Spectrometry methods, Oligosaccharides analysis, Oligosaccharides chemistry, Oligosaccharides standards, Polysaccharides analysis, Polysaccharides standards, Quality Control, United States, United States Food and Drug Administration, Antibodies, Monoclonal chemistry, Drug Industry standards, Polysaccharides chemistry
- Abstract
We surveyed 23 antibody-related marketing applications for glycoform analytical and functional information. Our database analysis shows a clear trend of increasing sophistication of analytical methods used to identify and quantify glycans. These have revealed a high degree of complexity and heterogeneity of glycans attached to antibody products. The nature of the complexity is influenced by product type and expression system, and may be associated with functional consequences in some but not all cases., (Published 2011. This article is a U.S. Government work and is in the public domain of the USA.)
- Published
- 2011
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