High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

Glycobiology

Volumn 21, Issue 7, 2011, Pages 949-959

  Goetze, Andrew M ^a   Liu, Y Diana ^a   Zhang, Zhongqi ^a   Shah, Bhavana ^a   Lee, Edward ^a   Bondarenko, Pavel V ^a   Flynn, Gregory C ^a  

^a AMGEN INC   (United States)

Author keywords

Fc glycans; high mannose; monoclonal; pharmacokinetics

Indexed keywords

FC RECEPTOR; GLYCAN; IMMUNOGLOBULIN G1; IMMUNOGLOBULIN G2; MANNOSE;

AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CIRCULATION TIME; DRUG BLOOD LEVEL; DRUG CLEARANCE; HUMAN; LIMIT OF QUANTITATION; MASS SPECTROMETRY; NORMAL HUMAN; PEPTIDE MAPPING; PRIORITY JOURNAL;

ADULT; ANTIBODIES, MONOCLONAL; CHROMATOGRAPHY, LIQUID; CLINICAL TRIALS, PHASE I AS TOPIC; GLYCOPEPTIDES; GLYCOPROTEINS; HUMANS; IMMUNOGLOBULIN FC FRAGMENTS; IMMUNOGLOBULIN G; MANNOSE; METABOLIC CLEARANCE RATE; POLYSACCHARIDES; SERUM; SPECTROMETRY, MASS, MATRIX-ASSISTED LASER DESORPTION-IONIZATION;

EID: 79958837668     PISSN: 09596658     EISSN: 14602423     Source Type: Journal    
DOI: 10.1093/glycob/cwr027     Document Type: Article

References (33)

1. Allavena P, Chieppa M, Monti P, Piemonti L. 2004. From pattern recognition receptor to regulator of homeostasis: The double-faced macrophage mannose receptor. Crit Rev Immunol. 24:179-192. (Pubitemid 39410864)
2. Ashwell G, Harford J. 1982. Carbohydrate-specific receptors of the liver. Ann Rev Biochem. 51:531-554.
3. Ashwell G, Morell AG. 1974. The role of surface carbohydrates in the hepatic recognition and transport of circulating glycoproteins. Adv Enzymol Relat Areas Mol Biol. 41:99-128.
4. Bailey MJ, Hooker AD, Adams CS, Zhang S, James DC. 2005. A platform for high-throughput molecular characterization of recombinant monoclonal antibodies. J Chromatogr A. 826:177-187. (Pubitemid 41446448)
5. Chen X, Flynn GC. 2007. Analysis of N-glycans from recombinant immuno-globulin G by on-line reversed-phase high-performance liquid chromato-graphy/mass spectrometry. Anal Biochem. 370:147-161. (Pubitemid 47484317)
6. Chen X, Liu YD, Flynn GC. 2009. The effect of Fc glycan forms on human IgG2 antibody clearance in humans. Glycobiology. 19:240-249.
7. Flynn GC, Chen X, Liu YD, Shah B, Zhang Z. 2010. Naturally occurring glycan forms of human immunoglobulins G1 and G2. Mol Immunol. 47:2074-2082.
8. French M. 1986. Serum IgG subclasses in normal adults. Monogr Allergy. 19:100-107.
9. Goetze AM, Schenauer MR, Flynn GC. 2010. Assessing monoclonal antibody product quality attribute criticality through clinical studies. MAbs. 2:500-507.
10. Harris RJ. 2005. Heterogeneity of recombinant antibodies: Linking structure to function. Dev Biol. 122:117-127. (Pubitemid 43002214)
11. Huang HZ, Nichols A, Liu D. 2009. Direct identification and quantification of aspartyl succinimide in an IgG2 mAb by RapiGest assisted digestion. Anal Chem. 81:1686-1692.
12. Huang L, Biolsi S, Bales KR, Kuchibhotla U. 2006. Impact of variable domain glycosylation on antibody clearance: An LC/MS characterization. Anal Biochem. 349:197-207. (Pubitemid 43184300)
13. Jefferis R. 2005. Glycosylation of recombinant antibody therapeutics. Biotechnol Prog. 21:11-16. (Pubitemid 40218466)
14. Jones AJ, Papac DI, Chin EH, Keck R, Baughman SA, Lin YS, Kneer J, Battersby JE. 2007. Selective clearance of glycoforms of a complex glyco-protein pharmaceutical caused by terminal N-acetylglucosamine is similar in humans and cynomolgus monkeys. Glycobiology. 17:529-540. (Pubitemid 47049940)
15. Kamoda S, Ishikawa R, Kakehi K. 2006. Capillary electrophoresis with laser-induced fluorescence detection for detailed studies on N-linked oligosac-charide profile of therapeutic recombinant monoclonal antibodies. J Chromatogr A. 1133:332-339. (Pubitemid 44573177)
16. Kanda Y, Yamada T, Mori K, Okazaki A, Inoue M, Kitajima-Miyama K, Kuni-Kamochi R, Nakano R, Yano K, Kakita S, et al. 2007. Comparison of biological activity among nonfucosylated therapeutic IgG1 antibodies with three different N-linked Fc oligosaccharides: The high-mannose, hybrid, and complex types. Glycobiology. 17:104-118. (Pubitemid 44932818)
17. Kogelberg H, Tolner B, Sharma SK, Lowdell MW, Qureshi U, Robson M, Hillyer T, Pedley RB, Vervecken W, Contreras R, et al. 2007. Clearance mechanism of a mannosylated antibody-enzyme fusion protein used in experimental cancer therapy. Glycobiology. 17:36-45. (Pubitemid 44932814)
18. Kozlowski S, Swann P. 2009. Considerations for biotechnology product quality by design. In: Rathore AS, Mhatre R, editors. Quality by Design for Biopharmaceuticals. Hoboken (USA): Wiley. p. 9-30.
19. Lee SJ, Evers S, Roeder D, Parlow AF, Risteli J, Risteli L, Lee YC, Feizi T, Langen H, Nussenzweig MC. 2002. Mannose receptor-mediated regulation of serum glycoprotein homeostasis. Science. 295:1898-1901. (Pubitemid 34218139)
20. Liu YD, Chen X, Enk JZ, Plant M, Dillon TM, Flynn GC. 2008. Human IgG2 antibody disulfide rearrangement in vivo. J Biol Chem. 283:29266-29272.
21. Mimura Y, Church S, Ghirlando R, Ashton PR, Dong S, Goodall M, Lund J, Jefferis R. 2000. The influence of glycosylatin on the thermal stability and effector function expression of human IgG1-Fc: Properties of a series of truncated glycoforms. Mol Immunol. 37:697-706. (Pubitemid 32244118)
22. Raghavan M, Bjorkman PJ. 1996. Fc receptors and their interaction with immunoglobulins. Annu Rev Cell Dev Biol. 12:181-210.
23. Rehder DS, Dillon TM, Pipes GD, Bondarenko PV. 2006. Reversed-phase liquid chromatography/mass spectrometry analysis of reduced monoclonal antibodies in pharmaceutics. J Chromatogr A. 1102:164-175. (Pubitemid 41790346)
24. Roopenian DC, Akilesh S. 2007. FcRn: The neonatal Fc receptor comes of age. Nat Rev. 7:715-725. (Pubitemid 47327396)
25. Shukla AA, Hubbard B, Tressel T, Guhan S, Low D. 2007. Downstream processing of monoclonal antibodies-application of platform approaches. J Chromatogr. 848:28-39. (Pubitemid 46367766)
26. Stahl PD. 1992. The mannose receptor and other macrophage lectins. Curr Opin Immunol. 4:49-52.
27. Stockert R. 1995. The asialoglycoprotein receptor and other macrophage lectins. Physiol Rev. 75:591-609.
28. Tao MH, Morrison SL. 1989. Studies of aglycosylated chimeric mouse-human IgG. Role of carbohydrate in the structure and effector functions mediated by the human IgG constant region. J Immunol. 143:2595-2601. (Pubitemid 19260070)
29. Wawrzynczak EJ, Cumber AJ, Parnell GD, Jones PT, Winter G. 1992. Blood clearance in the rat of a recombinant mouse monoclonal antibody lacking the N-linked oligosaccharide side chains of the CH2 domains. Mol Immunol. 29:213-220.
30. Wright A, Morrison SL. 1994. Effect of altered CH2-associated carbohydrate structure on the functional properties and in vivo fate of chi-meric mouse-human immunoglobulin G1. J Exp Med. 180:1087-1096.
31. Yu YQ, Gilar M, Lee PJ, Bouvier ES, Gebler JC. 2003. Enzyme-friendly, mass spectrometry-compatible surfactant for in-solution enzymatic digestion of proteins. Anal Chem. 75:6023-6028. (Pubitemid 37356487)
32. Zhang Z. 2009. Large-scale identification and quantification of covalent modifications in therapeutic proteins. Anal Chem. 81:8354-8364.
33. Zhang Z, Shah B. 2010. Prediction of collision-induced dissociation spectra of common N-glycopeptides for glycoform identification. Anal Chem. 82:10194-10202.