Development of biosimilars: Analysis of etanercept glycosylation as a case study

Journal of Bioanalysis and Biomedicine

Volumn 5, Issue 5, 2013, Pages 180-186

  DiPaola, Mario ^a   Li, Jing ^a   Stephens, Elaine ^a  

^a Blue Stream Laboratories   (United States)

Author keywords

Biosimilars; Glycan release; Glycopeptide; HILIC HPLC; Mass spectroscopy; O linked glycans: N linked glycans; Peptide mapping

Indexed keywords

BIOSIMILAR AGENT; ETANERCEPT; GLYCAN; GLYCOPROTEIN;

ARTICLE; BINDING SITE; CARBOHYDRATE ANALYSIS; DRUG DETERMINATION; DRUG FORMULATION; GLYCOSYLATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROPHILIC INTERACTION CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULAR WEIGHT; PEPTIDE MAPPING; PROCESS DEVELOPMENT; PROTEIN BINDING; STRUCTURE ANALYSIS;

EID: 84896715629     PISSN: None     EISSN: 1948593X     Source Type: Journal    
DOI: 10.4172/1948-593X.1000096     Document Type: Article

References (10)

1. Elliott S, Lorenzini T, Asher S, Aoki K, Brankow D, et al. (2003) Enhancement of therapeutic protein in vivo activities through glycoengineering. Nat Biotechnol 21 414-421.
2. LaTemple DC, Abrams JT, Zhang SY, Galili U (1999) Increased immunogenicity of tumor vaccines complexed with anti-Gal: studies in knockout mice for alpha1,3galactosyltransferase. Cancer Res 59: 3417-3423.
3. Macdougall IC (2002) Optimizing the use of erythropoietic agents--pharmacokinetic and pharmacodynamic considerations. Nephrol Dial Transplant 17 Suppl 5: 66-70.
4. Higuchi M, Oh-eda M, Kuboniwa H, Tomonoh K, Shimonaka Y, et al. (1992) Role of sugar chains in the expression of the biological activity of human erythropoietin. J Biol Chem 267: 7703-7709.
5. Dordal MS, Wang FF, Goldwasser E (1985) The role of carbohydrate in erythropoietin action. Endocrinology 116: 2293-2299.
6. Rothman RJ, Perussia B, Herlyn D, Warren L (1989) Antibody-dependent cytotoxicity mediated by natural killer cells is enhanced by castanospermineinduced alterations of IgG glycosylation. Mol Immunol 26: 1113-1123.
7. Elder JH, Alexander S (1982) endo-beta-N-acetylglucosaminidase F: endoglycosidase from Flavobacterium meningosepticum that cleaves both high-mannose and complex glycoproteins. Proc Natl Acad Sci U S A 79: 4540-4544.
8. Ruhaak LR, Zauner G, Huhn C, Bruggink C, Deelder AM, et al. (2010) Glycan labeling strategies and their use in identification and quantification. Anal Bioanal Chem 397: 3457-3481.
9. Hemström P, Irgum K (2006) Hydrophilic interaction chromatography. J Sep Sci 29: 1784-1821.
10. Botelho JC, Atwood JA, Cheng L, Varez-Manilla G, York WS, et al. (2008) Quantification by isobaric labeling (QUIBL) for the comparative glycomic study of O-linked glycans. International Journal of Mass Spectrometry 278: 137-142.