Glycosylation profiles of therapeutic antibody pharmaceuticals

European Journal of Pharmaceutics and Biopharmaceutics

Volumn 79, Issue 3, 2011, Pages 503-507

  Wacker, Christoph ^a   Berger, Christoph N ^a   Girard, Philippe ^a   Meier, Roger ^a  

^a Swissmedic   (Switzerland)

Author keywords

Antibody; Biotechnology; Capillary electrophoresis; Glycosylation

Indexed keywords

IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; OLIGOSACCHARIDE; RECOMBINANT ANTIBODY;

ANIMAL CELL; ARTICLE; CAPILLARY ELECTROPHORESIS; CELL GROWTH; DRUG EFFICACY; DRUG INDUSTRY; DRUG MARKETING; DRUG SAFETY; GLYCOSYLATION; IN VITRO STUDY; NONHUMAN;

ANIMALS; BIOPHARMACEUTICS; CHO CELLS; CRICETINAE; CRICETULUS; ELECTROPHORESIS, CAPILLARY; GLYCOSYLATION; HUMANS; IMMUNOGLOBULIN G; MICE; OLIGOSACCHARIDES; PROTEIN ENGINEERING; PROTEIN PROCESSING, POST-TRANSLATIONAL; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL;

EID: 80053941908     PISSN: 09396411     EISSN: 18733441     Source Type: Journal    
DOI: 10.1016/j.ejpb.2011.06.010     Document Type: Article

References (26)

1. J. Deisenhofer Crystallographic refinement and atomic models of a human Fc fragment and its complex with fragment B of protein A from Staphylococcus aureus at 2.9- and 2.8-A resolution Biochemistry 20 1981 2361 2370 (Pubitemid 11089772)
2. H.L. Spiegelberg, C.A. Abel, B.G. Fishkin, and H.M. Grey Localization of the carbohydrate within the variable region of light and heavy chains of human gamma g myeloma proteins Biochemistry 9 1970 4217 4223
3. J.R. Desjarlais, and G.A. Lazar Modulation of antibody effector function Exp. Cell Res. 317 2011 1278 1285
4. R. Jefferis Glycosylation of recombinant antibody therapeutics Biotechnol. Prog. 21 2005 11 16 (Pubitemid 40218466)
5. S. Krapp, Y. Mimura, R. Jefferis, R. Huber, and P. Sondermann Structural analysis of human IgG-Fc glycoforms reveals a correlation between glycosylation and structural integrity J. Mol. Biol. 325 2003 979 989 (Pubitemid 36263407)
6. P.N. Boyd, A.C. Lines, and A.K. Patel The effect of the removal of sialic acid, galactose and total carbohydrate on the functional activity of Campath-1H Mol. Immunol. 32 1995 1311 1318 (Pubitemid 26064897)
7. A. Wright, and S.L. Morrison Effect of glycosylation on antibody function: implications for genetic engineering Trends Biotechnol. 15 1997 26 32 (Pubitemid 27067150)
8. R. Jefferis, J. Lund, and M. Goodall Recognition sites on human IgG for Fc gamma receptors: the role of glycosylation Immunol. Lett. 44 1995 111 117
9. P. Umana, J. Jean-Mairet, R. Moudry, H. Amstutz, and J.E. Bailey Engineered glycoforms of an antineuroblastoma IgG1 with optimized antibody-dependent cellular cytotoxic activity Nat. Biotechnol. 17 1999 176 180 (Pubitemid 29072543)
10. S.E. O'Connor, and B. Imperiali Modulation of protein structure and function by asparagine-linked glycosylation Chem. Biol. 3 1996 803 812 (Pubitemid 27005735)
11. J.N. Arnold, M.R. Wormald, R.B. Sim, P.M. Rudd, and R.A. Dwek The impact of glycosylation on the biological function and structure of human immunoglobulins Annu. Rev. Immunol. 25 2007 21 50 (Pubitemid 46697901)
12. ICH harmonised tripartite guideline - specifications: test procedures and acceptance criteria for biotechnological/biological products; Q6B, 1999 < http://www.ich.org/MediaServer.jser?@-ID=432&@-MODE=GLB >
13. ICH harmonised tripartite guideline - comparability of biotechnological/biological products subject to changes in their manufacturing process; Q5E, 2004 < http://www.ich.org/MediaServer.jser?@-ID=1196&@- MODE=GLB >.
14. F.T. Chen, and R.A. Evangelista Profiling glycoprotein N-linked oligosaccharide by capillary electrophoresis Electrophoresis 19 1998 2639 2644 (Pubitemid 28541310)
15. T.P. Patel, R.B. Parekh, B.J. Moellering, and C.P. Prior Different culture methods lead to differences in glycosylation of a murine IgG monoclonal antibody Biochem. J. 285 Pt. 3 1992 839 845
16. H. Schachter Biosynthetic controls that determine the branching and microheterogeneity of protein-bound oligosaccharides Biochem. Cell Biol. 64 1986 163 181 (Pubitemid 16036405)
17. R.L. Shields, J. Lai, R. Keck, L.Y. O'Connell, K. Hong, Y.G. Meng, S.H. Weikert, and L.G. Presta Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity J. Biol. Chem. 277 2002 26733 26740 (Pubitemid 34951677)
18. J.A. Serrato, V. Hernandez, S. Estrada-Mondaca, L.A. Palomares, and O.T. Ramirez Differences in the glycosylation profile of a monoclonal antibody produced by hybridomas cultured in serum-supplemented, serum-free or chemically defined media Biotechnol. Appl. Biochem. 47 2007 113 124 (Pubitemid 46867111)
19. U. Galili Immune response, accommodation, and tolerance to transplantation carbohydrate antigens Transplantation 78 2004 1093 1098 (Pubitemid 39426422)
20. J. Qian, T. Liu, L. Yang, A. Daus, R. Crowley, and Q. Zhou Structural characterization of N-linked oligosaccharides on monoclonal antibody cetuximab by the combination of orthogonal matrix-assisted laser desorption/ionization hybrid quadrupole-quadrupole time-of-flight tandem mass spectrometry and sequential enzymatic digestion Anal. Biochem. 364 2007 8 18 (Pubitemid 46497948)
21. C.H. Chung, B. Mirakhur, E. Chan, Q.T. Le, J. Berlin, M. Morse, B.A. Murphy, S.M. Satinover, J. Hosen, D. Mauro, R.J. Slebos, Q. Zhou, D. Gold, T. Hatley, D.J. Hicklin, and T.A. Platts-Mills Cetuximab-induced anaphylaxis and IgE specific for galactose-alpha-1,3-galactose N. Engl. J. Med. 358 2008 1109 1117 (Pubitemid 351398485)
22. A. Varki Glycan-based interactions involving vertebrate sialic-acid-recognizing proteins Nature 446 2007 1023 1029 (Pubitemid 46676064)
23. D. Ghaderi, R.E. Taylor, V. Padler-Karavani, S. Diaz, and A. Varki Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins Nat. Biotechnol. 28 2010 863 867
24. G.C. Flynn, X. Chen, Y.D. Liu, B. Shah, and Z. Zhang Naturally occurring glycan forms of human immunoglobulins G1 and G2 Mol. Immunol. 47 2010 2074 2082
25. A.M. Goetze, Y.D. Liu, Z. Zhang, B. Shah, E. Lee, P.V. Bondarenko, and G.C. Flynn High mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans Glycobiology 2011
26. T. Shinkawa, K. Nakamura, N. Yamane, E. Shoji-Hosaka, Y. Kanda, M. Sakurada, K. Uchida, H. Anazawa, M. Satoh, M. Yamasaki, N. Hanai, and K. Shitara The absence of fucose but not the presence of galactose or bisecting N-acetylglucosamine of human IgG1 complex-type oligosaccharides shows the critical role of enhancing antibody-dependent cellular cytotoxicity J. Biol. Chem. 278 2003 3466 3473 (Pubitemid 36801263)