1,788
Views
14
CrossRef citations to date
0
Altmetric
Reports

The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development

, , , , , , , & show all
Pages 562-570 | Received 16 Oct 2014, Accepted 25 Jan 2015, Published online: 01 May 2015

References

  • Kozlowski S, Woodcock J, Midthun K, Sherman RB. Developing the nation's biosimilars program. N Engl J Med 2011; 365:385-8; PMID:21812668; http://dx.doi.org/10.1056/NEJMp1107285
  • Kálmán-Szekeres Z, Olajos M, Ganzler K. Analytical aspects of biosimilarity issues of protein drugs. J Pharm Biomed Anal 2012; 69:185-95; http://dx.doi.org/10.1016/j.jpba.2012.04.037
  • Carter P, Presta L, Gorman CM, Ridgway JBB, Henner D, Wong WLT, Rowland AM, Kott C, Carver ME, Spepard HM. Humanization of an anti-p185Her2 antibody for human cancer therapy. Proc Natl Acad Sci U S A 1992; 89:4285-9; http://dx.doi.org/10.1073/pnas.89.10.4285
  • Knight DM, Trinh H, Le J, Siegel S, Shealy D, McDonough M, Scallon B, Moore MA, Vilcek J, Daddona P, et al. Construction and intial characterization of a mouse-human chimeric anti-TNF antibody. Mol Immunol 1993; 30:1443-53; PMID:8232330; http://dx.doi.org/10.1016/0161-5890(93)90106-L
  • Jian X-R, Song A, Bergelson S, Arroll T, Parehk B, May K, Chung S, Strouse R, Mire-Sluis A, Schenerman M. Advances in the assessment and aontrol of the effector functions of therapeutic antibodes. Nat Rev 2011; 10:101-10; PMID:21283105
  • Mitoma H, Horiuchi T, Tsukamoto H, Tamimoto Y, Kimoto Y, Uchino A, To K, Harashima S-i, Hatta N, Harada M. Mechanisms of cytoxic effect of anti-tumor necrosis factor agens on transmembrane tumor necrosis factor alpha-expressing cells. Arthiritis Rheumatism 2008; 58:1248-57; http://dx.doi.org/10.1002/art.23447
  • Hudis C. Trastuzumab – mechamism of action and use in clinical practice. N Engl J Med 2007; 357:39-51; PMID:17611206; http://dx.doi.org/10.1056/NEJMra043186
  • Harris RJ, Kabakoff B, Macchi FD, Shen FJ, Kwong M, Andya JD, Shire SJ, Bjork N, Totpal K, Chen AB. Identification of multiple sources of charge heterogeneity in a recombinant antibody. J Chromatography B 2001; 752:233-45; http://dx.doi.org/10.1016/S0378-4347(00)00548-X
  • Hacker DL, De Jesus M, Wurm FM. 25 years of recombinant proteins from reactor-grown cells — Where do we go from here? Biotechnol Adv 2009; 27:1023-7; PMID:19463938; http://dx.doi.org/10.1016/j.biotechadv.2009.05.008
  • De Jesus M, Wurm FM. Manufacturing recombinant proteins in kg-ton quantities using animal cells in bioreactors. Eur J Pharm and Biopharm 2011; 78:184-8; PMID:21256214; http://dx.doi.org/10.1016/j.ejpb.2011.01.005
  • Lazar G, Dang W, Karki S, Vafa O, Peng J, Hyun L, Chan C, Chung H, Elvazi A, Yoder S, et al. Engineered antibody Fc variants with enhanced effector function. Proc Natl Acad Sci 2006; 103:4005-10; http://dx.doi.org/10.1073/pnas.0508123103
  • Moore G, Chen H, Karki S, Lazar G. Engineered Fc variant antibodies with enhanced ability to recruite complement and mediate effector funtions. mAbs 2010; 2:181-9; PMID:20150767; http://dx.doi.org/10.4161/mabs.2.2.11158
  • Saphire EO, Stanfield R, Crispin MDM, Parren P, Rudd P, Dwek R, Burton D, Wilson I. Contrasting IgG structures reveal extreme asymmetry and flexibility. J Mol Biol 2002; 319:9-18; PMID:12051932; http://dx.doi.org/10.1016/S0022-2836(02)00244-9
  • Kanda Y, Yamada T, Mori K, Okazaki A, Inoue M, Kitajima-Miyama K, Kuni-Kamochi R, Nakano R, Yano K, Kakita S, et al. Comparison of biological activity among nonfucosylated therapeutic IgG1antibodies with three different N-linked Fc oligosaccharides: the high-mannose,hybrid, and complex types. Glycobiology 2006; 17:104-18; PMID:17012310; http://dx.doi.org/10.1093/glycob/cwl057
  • Niwa R, Natsume A, Uehara A, Wakitani M, Iida S, Uchida K, Satoh M, Shitara K. IgG subclass-independent improvement of antibody-dependent cellular cytotoxicity by fucose removal from Asn297-linked oligosaccharides. J Immunol Methods 2006; 306:151-60; http://dx.doi.org/10.1016/j.jim.2005.08.009
  • Yu M, Brown D, Reed C, Chung S, Lutman J, Stefanich E, Wong A, Stefan J-P, Bayer R. Production, characterization and pharmacokinetic properties of antibodies with N-linked Mannose-5 glycans. mAbs 2012; 4:475-87; PMID:22699308; http://dx.doi.org/10.4161/mabs.20737
  • Kumpel B, Rademacher T, Rook G, Williams P, Wilson I. Galactosylation of human IgG monoclonal anti-D produced by EBV-transformed B-lymphoblastoid cell lines is depedent on culture media and affects Fc receptor-mediated functional activity. Hum Antibodies Hybridomas 1994; 5:143-51; PMID:7756579
  • Hodoniczky J, Zheng YZ, James D. Control of recombinant monoclonal antibody effector functions by Fc N-glycan remodeling in vitro. Biotechnol Prog 2005; 21:1644-52; PMID:16321047; http://dx.doi.org/10.1021/bp050228w
  • Wright A, Morrison S. Effect of altered CH2-associated carbohydrate structure on the functional properties and in vivo fate of chimeric mouse-human immunoglobulin G1. J Exp Med 1994; 180:1087-96; PMID:8064227; http://dx.doi.org/10.1084/jem.180.3.1087
  • Anthony R, Nimmerjahn F, Ashline D, Renhold V, Paulson J, Ravetch J. A recombinant IgG Fc that recapitulates teh anti-inflammitory activity of IVIG. Science 2008; 320:373-6; PMID:18420934; http://dx.doi.org/10.1126/science.1154315
  • Houde D, Peng Y, Berkowitz S, Engen J. Post-translational modifications differentially effect IgG1 conformation and receptor binding. Mol Cell Proteomics 2010; 9:1716-28; PMID:20103567; http://dx.doi.org/10.1074/mcp.M900540-MCP200
  • Malaise M, Franchimont P, Bouillene C, Houssier C, Mahieu P. Increased concanavalin A-binding capacity of immunoglobulin G purified from sera of patients with rheumatoid arthritis. Clin Exp Immunol 1987; 68:543-51
  • Kaneko Y, Nimmerjahn F, Ravetch J. Anti-inflammatory activity of immunoglobulin G resulting from Fc sialylation. Science 2006; 313:670-3; PMID:16888140; http://dx.doi.org/10.1126/science.1129594
  • Visser J, Feuerstein I, Stangler T, Schmiederer T, Fritsch C. Physicochemical and functional comparability between the proposed biosimilar rituximab GP2013 and originator rituximab. BioDrugs 2013; 27:495-507; PMID:23649935; http://dx.doi.org/10.1007/s40259-013-0036-3
  • Rathore A, Winkle H. Quality by design for biopharmaceuticals. Nat Biotechnol 2009; 27:26-34; PMID:19131992; http://dx.doi.org/10.1038/nbt0109-26
  • Goetze A, Liu Y, Zhang Z, Shah B, Lee E, Bondarenko P, Flynn G. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. Glycobiology 2011; 21:949-69; PMID:21421994; http://dx.doi.org/10.1093/glycob/cwr027
  • Chung S, Quarmby V, Gao X, Ying Y, Lin L, Reed C, Fong C, Lau W, Qui Z, Shen A, et al. Quantitative evaluation of fucose reducing effects in a humanized antibody on FcGamma receptor biniding and antibody-dependent cell-mediated cytotoxicity activities. mAbs 2012; 4:326-40; PMID:22531441; http://dx.doi.org/10.4161/mabs.19941

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.