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Editorial

Marketing approval of mogamulizumab

A triumph for glyco-engineering

&
Pages 419-425 | Published online: 01 Jul 2012

References

  • Paz-Ares LG, Gomez-Roca C, Delord JP, Cervantes A, Markman B, Corral J, et al. Phase I pharmacokinetic and pharmacodynamic dose-escalation study of RG7160 (GA201), the first glycoengineered monoclonal antibody against the epidermal growth factor receptor, in patients with advanced solid tumors. J Clin Oncol 2011; 29:3783 - 90; http://dx.doi.org/10.1200/JCO.2011.34.8888; PMID: 21900113
  • Beck A, Wagner-Rousset E, Bussat MC, Lokteff M, Klinguer-Hamour C, Haeuw JF, et al. Trends in glycosylation, glycoanalysis and glycoengineering of therapeutic antibodies and Fc-fusion proteins. Curr Pharm Biotechnol 2008; 9:482 - 501; http://dx.doi.org/10.2174/138920108786786411; PMID: 19075687
  • Reichert JM. Marketed therapeutic antibodies compendium. MAbs 2012; 4:413 - 5; http://dx.doi.org/10.4161/mabs.19931; PMID: 22531442
  • Jefferis R. Isotype and glycoform selection for antibody therapeutics. Arch Biochem Biophys 2012; In press http://dx.doi.org/10.1016/j.abb.2012.03.021; PMID: 22465822
  • Raju TS, Jordan RE. Galactosylation variations in marketed therapeutic antibodies. MAbs 2012; 4:385 - 91; http://dx.doi.org/10.4161/mabs.19868; PMID: 22531450
  • Sundaram S, Matathia A, Qian J, Zhang J, Hsieh MC, Liu T, et al. An innovative approach for the characterization of the isoforms of a monoclonal antibody product. MAbs 2011; 3:505 - 12; http://dx.doi.org/10.4161/mabs.3.6.18090; PMID: 22123057
  • Mariotte D, Dupont B, Gervais R, Galais MP, Laroche D, Tranchant A, et al. Anti-cetuximab IgE ELISA for identification of patients at a high risk of cetuximab-induced anaphylaxis. MAbs 2011; 3:396 - 401; http://dx.doi.org/10.4161/mabs.3.4.16293; PMID: 21654207
  • Daguet A, Watier H. 2nd Charles Richet et Jules Héricourt workshop: therapeutic antibodies and anaphylaxis; May 31-June 1, 2011, Tours, France. MAbs 2011; 3:417 - 21; http://dx.doi.org/10.4161/mabs.3.5.17485; PMID: 21857165
  • Lammerts van Bueren JJ, Rispens T, Verploegen S, van der Palen-Merkus T, Stapel S, Workman LJ, et al. Anti-galactose-α-1,3-galactose IgE from allergic patients does not bind α-galactosylated glycans on intact therapeutic antibody Fc domains. Nat Biotechnol 2011; 29:574 - 6; http://dx.doi.org/10.1038/nbt.1912; PMID: 21747378
  • Wang C, He X, Zhou B, Li J, Li B, Qian W, et al. Phase 1 study of anti-epidermal growth factor receptor monoclonal antibody in patients with solid tumors. MAbs 2011; 3:67 - 75; http://dx.doi.org/10.4161/mabs.3.1.14021; PMID: 21051930
  • Beck A, -Cianférani S, Van Dorsselaer A. Biosimilar, biobetter and next generation antibody characterization by mass spectrometry. Anal Chem 2012; In press http://dx.doi.org/10.1021/ac3002885; PMID: 22510259
  • Pacis E, Yu M, Autsen J, Bayer R, Li F. Effects of cell culture conditions on antibody N-linked glycosylation-what affects high mannose 5 glycoform. Biotechnol Bioeng 2011; In press http://dx.doi.org/10.1002/bit.23200; PMID: 21557201
  • Beck A, Cochet O, Wurch T. GlycoFi’s technology to control the glycosylation of recombinant therapeutic proteins. Expert Opin Drug Discov 2010; 5:95 - 111; http://dx.doi.org/10.1517/17460440903413504
  • Cérutti M, Golay J. Lepidopteran cells, an alternative for the production of recombinant antibodies?. MAbs 2012; 4:294 - 309; http://dx.doi.org/10.4161/mabs.19942; PMID: 22531440
  • Fischer R, Schillberg S, Hellwig S, Twyman RM, Drossard J. GMP issues for recombinant plant-derived pharmaceutical proteins. Biotechnol Adv 2012; 30:434 - 9; http://dx.doi.org/10.1016/j.biotechadv.2011.08.007; PMID: 21856403
  • Goetze AM, Schenauer MR, Flynn GC. Assessing monoclonal antibody product quality attribute criticality through clinical studies. MAbs 2010; 2:500 - 7; http://dx.doi.org/10.4161/mabs.2.5.12897; PMID: 20671426
  • Goetze AM, Liu YD, Zhang Z, Shah B, Lee E, Bondarenko PV, et al. High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans. Glycobiology 2011; 21:949 - 59; http://dx.doi.org/10.1093/glycob/cwr027; PMID: 21421994
  • Alessandri L, Ouellette D, Acquah A, Rieser M, LeBlond D, Saltarelli M, et al. Increased serum clearance of oligomannose species present on a human IgG1 molecule. MAbs 2012; In press
  • Beck A, Wurch T, Bailly C, Corvaia N. Strategies and challenges for the next generation of therapeutic antibodies. Nat Rev Immunol 2010; 10:345 - 52; http://dx.doi.org/10.1038/nri2747; PMID: 20414207
  • Umaña P, Jean-Mairet J, Moudry R, Amstutz H, Bailey JE. Engineered glycoforms of an antineuroblastoma IgG1 with optimized antibody-dependent cellular cytotoxic activity. Nat Biotechnol 1999; 17:176 - 80; http://dx.doi.org/10.1038/6179; PMID: 10052355
  • Kubota T, Niwa R, Satoh M, Akinaga S, Shitara K, Hanai N. Engineered therapeutic antibodies with improved effector functions. Cancer Sci 2009; 100:1566 - 72; http://dx.doi.org/10.1111/j.1349-7006.2009.01222.x; PMID: 19538497
  • Yamane-Ohnuki N, Kinoshita S, Inoue-Urakubo M, Kusunoki M, Iida S, Nakano R, et al. Establishment of FUT8 knockout Chinese hamster ovary cells: an ideal host cell line for producing completely defucosylated antibodies with enhanced antibody-dependent cellular cytotoxicity. Biotechnol Bioeng 2004; 87:614 - 22; http://dx.doi.org/10.1002/bit.20151; PMID: 15352059
  • Olivier S, Jacoby M, Brillon C, Bouletreau S, Mollet T, Nerriere O, et al. EB66 cell line, a duck embryonic stem cell-derived substrate for the industrial production of therapeutic monoclonal antibodies with enhanced ADCC activity. MAbs 2010; 2:405 - 15; PMID: 20562528
  • Saint-Jore-Dupas C, Faye L, Gomord V. From planta to pharma with glycosylation in the toolbox. Trends Biotechnol 2007; 25:317 - 23; http://dx.doi.org/10.1016/j.tibtech.2007.04.008; PMID: 17493697
  • Gasdaska JR, Sherwood S, Regan JT, Dickey LF. An afucosylated anti-CD20 monoclonal antibody with greater antibody-dependent cellular cytotoxicity and B-cell depletion and lower complement-dependent cytotoxicity than rituximab. Mol Immunol 2012; 50:134 - 41; http://dx.doi.org/10.1016/j.molimm.2012.01.001; PMID: 22305040
  • Gramer MJ, Eckblad JJ, Donahue R, Brown J, Shultz C, Vickerman K, et al. Modulation of antibody galactosylation through feeding of uridine, manganese chloride, and galactose. Biotechnol Bioeng 2011; 108:1591 - 602; http://dx.doi.org/10.1002/bit.23075; PMID: 21328321
  • Hamilton SR, Davidson RC, Sethuraman N, Nett JH, Jiang Y, Rios S, et al. Humanization of yeast to produce complex terminally sialylated glycoproteins. Science 2006; 313:1441 - 3; http://dx.doi.org/10.1126/science.1130256; PMID: 16960007
  • Lugovskoy AA, Reichert JM, Beck A. 7th Annual European Antibody Congress 2011: November 29-December 1, 2011, Geneva, Switzerland. MAbs 2012; 4:134 - 52; http://dx.doi.org/10.4161/mabs.4.2.19426; PMID: 22453093
  • Decker EL, Reski R. Glycoprotein production in moss bioreactors. Plant Cell Rep 2012; 31:453 - 60; http://dx.doi.org/10.1007/s00299-011-1152-5; PMID: 21960098
  • Yamane-Ohnuki N, Satoh M. Production of therapeutic antibodies with controlled fucosylation. MAbs 2009; 1:230 - 6; http://dx.doi.org/10.4161/mabs.1.3.8328; PMID: 20065644
  • Oflazoglu E, Audoly LP. Evolution of anti-CD20 monoclonal antibody therapeutics in oncology. MAbs 2010; 2:14 - 9; http://dx.doi.org/10.4161/mabs.2.1.10789; PMID: 20081379
  • Zhang N, Liu L, Dumitru CD, Cummings NR, Cukan M, Jiang Y, et al. Glycoengineered Pichia produced anti-HER2 is comparable to trastuzumab in preclinical study. MAbs 2011; 3:289 - 98; http://dx.doi.org/10.4161/mabs.3.3.15532; PMID: 21487242
  • Sehn LH, Assouline SE, Stewart DA, Mangel J, Gascoyne RD, Fine G, et al. A phase 1 study of obinutuzumab induction followed by 2 years of maintenance in patients with relapsed CD20-positive B-cell malignancies. Blood 2012; 119:5118 - 25; http://dx.doi.org/10.1182/blood-2012-02-408773; PMID: 22438256