Analytical characterization of ch14.18

References

• Reichert JM, Rosensweig CJ, Faden LB, Dewitz MC. Monoclonal antibody successes in the clinic. Nat Biotechnol 2005; 23:1073 - 1078; PMID: 16151394; http://dx.doi.org/10.1038/nbt0905-1073
   PubMed Web of Science ®Google Scholar
• Reichert JM, Valge-Archer VE. Development trends for monoclonal antibody cancer therapeutics. Nat Rev Drug Discov 2007; 6:349 - 356; PMID: 17431406; http://dx.doi.org/10.1038/nrd2241
   PubMed Web of Science ®Google Scholar
• Glennie MJ, Johnson PW. Clinical trials of antibody therapy. Immunol Today 2000; 21:403 - 410; PMID: 10916144; http://dx.doi.org/10.1016/S0167-5699(00)01669-8
   PubMedGoogle Scholar
• Shapiro MA, Swann PG, Hartsough M. Dubel S. Regulatory considerations in the development of monoclonal antibodies for diagnosis and therapy. Handbook of Therapeutic Antibodies 2005; Weinham, Germany Wiley VCH
   Google Scholar
• Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004; 22:1383 - 1391; PMID: 15529163; http://dx.doi.org/10.1038/nbt1030
   PubMed Web of Science ®Google Scholar
• Kozlowski S, Swann PG. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv Drug Deliv Rev 2006; 58:707 - 722; PMID: 16828921; http://dx.doi.org/10.1016/j.addr.2006.05.002
   PubMed Web of Science ®Google Scholar
• Woodcock J, Griffin J, Behrman R, Cherney B, Crescenzi T, Fraser B, et al. The FDA's assessment of follow-on protein products: a historical perspective. Nat Rev Drug Discov 2007; 6:437 - 442; PMID: 17633790; http://dx.doi.org/10.1038/nrd2307
   PubMed Web of Science ®Google Scholar
• Wang W, Singh S, Zeng DL, King K, Nema S. Antibody structure, instability and formulation. J Pharm Sci 2007; 96:1 - 26; PMID: 16998873; http://dx.doi.org/10.1002/jps.20727
   PubMed Web of Science ®Google Scholar
• Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res 2004; 21:897 - 903; PMID: 15212151; http://dx.doi.org/10.1023/B:PHAM.0000029275.41323.a6
   PubMed Web of Science ®Google Scholar
• Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J 2006; 8:501 - 507; PMID: 17025268; http://dx.doi.org/10.1208/aapsj080359
   PubMed Web of Science ®Google Scholar
• Barker E, Mueller BM, Handgretinger R, Herter M, Yu AL, Reisfeld RA. Effect of a chimeric anti-ganglioside GD2 antibody on cell-mediated lysis of human neuroblastoma cells. Cancer Res 1991; 51:144 - 149; PMID: 1988079
   PubMed Web of Science ®Google Scholar
• Simon T, Hero B, Faldum A, Handgretinger R, Schrappe M, Niethammer D, et al. Consolidation treatment with chimeric anti-GD2-antibody ch14.18 in children older than 1 year with metastatic neuroblastoma. J Clin Oncol 2004; 22:3549 - 3557; PMID: 15337804; http://dx.doi.org/10.1200/JCO.2004.08.143
   PubMed Web of Science ®Google Scholar
• Simon T, Hero B, Faldum A, Handgretinger R, Schrappe M, Niethammer D, et al. Infants with stage 4 neuroblastoma: the impact of the chimeric anti-GD2-antibody ch14.18 consolidation therapy. Klin Padiatr 2005; 217:147 - 152; PMID: 15858706; http://dx.doi.org/10.1055/s-2005-836518
   PubMed Web of Science ®Google Scholar
• Hartmann WK, Saptharishi N, Yang XY, Mitra G, Soman G. Characterization and analysis of thermal denaturation of antibodies by size exclusion high-performance liquid chromatography with quadruple detection. Anal Biochem 2004; 325:227 - 239; PMID: 14751257; http://dx.doi.org/10.1016/j.ab.2003.10.031
   PubMed Web of Science ®Google Scholar
• Anumula KR, Dhume ST. High resolution and high sensitivity methods for oligosaccharide mapping and characterization by normal phase high performance liquid chromatography following derivatization with highly fluorescent anthranilic acid. Glycobiology 1998; 8:685 - 694; PMID: 9621109; http://dx.doi.org/10.1093/glycob/8.7.685
   PubMed Web of Science ®Google Scholar
• Jefferis R. Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action. Trends Pharmacol Sci 2009; 30:356 - 362; PMID: 19552968; http://dx.doi.org/10.1016/j.tips.2009.04.007
   PubMed Web of Science ®Google Scholar
• Mujoo K, Kipps TJ, Yang HM, Cheresh DA, Wargalla U, Sander DJ, et al. Functional properties and effect on growth suppression of human neuroblastoma tumors by isotype switch variants of monoclonal antiganglioside GD2 antibody 14.18. Cancer Res 1989; 49:2857 - 2861; PMID: 2720646
   PubMed Web of Science ®Google Scholar
• Mueller BM, Romerdahl CA, Gillies SD, Reisfeld RA. Enhancement of antibody-dependent cytotoxicity with a chimeric anti-GD2 antibody. J Immunol 1990; 144:1382 - 1386; PMID: 2303711
   PubMed Web of Science ®Google Scholar
• Honsik CJ, Jung G, Reisfeld RA. Lymphokine-activated killer cells targeted by monoclonal antibodies to the disialogangliosides GD2 and GD3 specifically lyse human tumor cells of neuroectodermal origin. Proc Natl Acad Sci USA 1986; 83:7893 - 7897; PMID: 3094017; http://dx.doi.org/10.1073/pnas.83.20.7893
   PubMed Web of Science ®Google Scholar
• Barker E, Mueller BM, Handgretinger R, Herter M, Yu AL, Reisfeld RA. Effect of a chimeric anti-ganglioside GD2 antibody on cell-mediated lysis of human neuroblastoma cells. Cancer Res 1991; 51:144 - 149; PMID: 1988079
   PubMed Web of Science ®Google Scholar
• Robinson CJ, Jones C. Quality control and analytical techniques for biopharmaceuticals. Bioanalysis 2011; 3:81 - 95; PMID: 21175369; http://dx.doi.org/10.4155/bio.10.161
   PubMed Web of Science ®Google Scholar
• Vázquez-Rey M, Lang DA. Aggregates in monoclonal antibody manufacturing processes. Biotechnol Bioeng 2011; 108:1494 - 1508; PMID: 21480193; http://dx.doi.org/10.1002/bit.23155
   PubMed Web of Science ®Google Scholar
• Soman G, Yang XY, Jiang H, Giardina S, Mitra G. Comparison of GD2 binding capture ELISA assays for anti-GD2-antibodies using GD2-coated plates and a GD2-expressing cell-based ELISA. J Immunol Methods 2011; 373:181 - 191; PMID: 21893062; http://dx.doi.org/10.1016/j.jim.2011.08.016
   PubMed Web of Science ®Google Scholar
• Janini G, Saptharishi N, Waselus M, Soman G. Element of a validation method for MU-B3 monoclonal antibody using an imaging capillary isoelectric focusing system. Electrophoresis 2002; 23:1605 - 1611; PMID: 12179978; http://dx.doi.org/10.1002/1522-2683(200206)23:11<1605::AID-ELPS1605>3.0.CO;2-O
   PubMed Web of Science ®Google Scholar
• Soman G, Saptharishi N, Janini GM, Mitra G. Imaged capillary isoelectric focusing of proteins. Bioforum Int 2002; 6:263 - 267
   Google Scholar
• Sharma VK, Kalonia DS. Wang W, Robert CJ. Experimental detection and characterization of protein aggregates. Aggregation of Therapeutic Proteins 2010; NJ USA John Wiley and Sons Publishing 205 - 206
   Google Scholar
• Singh SK, Afonina N, Awwad M, Bechtold-Peters K, Blue JT, Chou D, et al. An industry perspective on the monitoring of subvisible particles as a quality attribute for protein therapeutics. J Pharm Sci 2010; 99:3302 - 3321; PMID: 20310025; http://dx.doi.org/10.1002/jps.22097
   PubMed Web of Science ®Google Scholar
• Narhi LO, Jiang Y, Cao S, Benedek K, Shnek D. A critical review of analytical methods for subvisible and visible particles. Curr Pharm Biotechnol 2009; 10:373 - 381; PMID: 19519412; http://dx.doi.org/10.2174/138920109788488905
   PubMed Web of Science ®Google Scholar
• 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 - 959; PMID: 21421994; http://dx.doi.org/10.1093/glycob/cwr027
   PubMed Web of Science ®Google Scholar
• Chen X, Liu YD, Flynn GC. The effect of Fc glycan forms on human IgG2 antibody clearance in humans. Glycobiology 2009; 19:240 - 249; PMID: 18974198; http://dx.doi.org/10.1093/glycob/cwn120
   PubMed Web of Science ®Google Scholar
• Shinkawa T, Nakamura K, Yamane N, Shoji-Hosaka E, Kanda Y, Sakurada M, et al. 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 2003; 278:3466 - 3473; PMID: 12427744; http://dx.doi.org/10.1074/jbc.M210665200
   PubMed Web of Science ®Google Scholar
• Shields RL, Lai J, Keck R, O'Connell LY, Hong K, Meng YG, et al. Lack of fucose on human IgG1 N-linked oligosaccharide improves binding to human Fcgamma RIII and antibody-dependent cellular toxicity. J Biol Chem 2002; 277:26733 - 26740; PMID: 11986321; http://dx.doi.org/10.1074/jbc.M202069200
   PubMed Web of Science ®Google Scholar
• Davies J, Jiang L, Pan LZ, LaBarre MJ, Anderson D, Reff M. Expression of GnTIII in a recombinant anti-CD20 CHO production cell line: Expression of antibodies with altered glycoforms leads to an increase in ADCC through higher affinity for FCγRIII. Biotechnol Bioeng 2001; 74:288 - 294; PMID: 11410853; http://dx.doi.org/10.1002/bit.1119
   PubMed Web of Science ®Google Scholar
• Hodoniczky J, Zheng YZ, James DC. Control of recombinant monoclonal antibody effector functions by Fc N-glycan remodeling in vitro. Biotechnol Prog 2005; 21:1644 - 1652; PMID: 16321047; http://dx.doi.org/10.1021/bp050228w
   PubMed Web of Science ®Google Scholar
• Chan AC, Carter PJ. Therapeutic antibodies for autoimmunity and inflammation. Nat Rev Immunol 2010; 10:301 - 316; PMID: 20414204; http://dx.doi.org/10.1038/nri2761
   PubMed Web of Science ®Google Scholar
• Jiang XR, Song A, Bergelson S, Arroll T, Parekh B, May K, et al. Advances in the assessment and control of the effector functions of therapeutic antibodies. Nat Rev Drug Discov 2011; 10:101 - 111; PMID: 21283105; http://dx.doi.org/10.1038/nrd3365
   PubMed Web of Science ®Google Scholar
• Griggs J, Zinkewich-Peotti K. The state of the art: immune-mediated mechanisms of monoclonal antibodies in cancer therapy. Br J Cancer 2009; 101:1807 - 1182; PMID: 19809433; http://dx.doi.org/10.1038/sj.bjc.6605349
   PubMed Web of Science ®Google Scholar
• Nimmerjahn F, Ravetch JV. Fcgamma receptors as regulators of immune responses. Nat Rev Immunol 2008; 8:34 - 47; PMID: 18064051; http://dx.doi.org/10.1038/nri2206
   PubMed Web of Science ®Google Scholar
• Zeck A, Pohlentz G, Schlothauer T, Peter-Katalinić J, Regula JT. Cell type-specific and site directed N-glycosylation pattern of FcγRIIIa. J Proteome Res 2011; 10:3031 - 3039; PMID: 21561106; http://dx.doi.org/10.1021/pr1012653
   PubMed Web of Science ®Google Scholar
• Sen G, Chakraborty M, Foon KA, Reisfeld RA. Bhattacharya-Chatterjee M, Preclinical evaluation in nonhuman primates of murine monoclonal anti-idiotype antibody that mimics the disialoganglioside GD2. Clin Cancer Res 1997; 3:1969 - 1976; PMID: 9815586
   PubMed Web of Science ®Google Scholar
• Yoshida S, Fukumoto S, Kawaguchi H, Sato S, Ueda R, Furukawa K. Ganglioside G(D2) in small cell lung cancer cell lines: enhancement of cell proliferation and mediation of apoptosis. Cancer Res 2001; 61:4244 - 4252; PMID: 11358851
   PubMed Web of Science ®Google Scholar
• Yang X, Chen E, Jiang H, Muszynski K, Harris RD, Giardina SL, et al. Evaluation of IRES-mediated, cell-type-specific cytotoxicity of poliovirus using a colorimetric cell proliferation assay. J Virol Methods 2009; 155:44 - 54; PMID: 18951922; http://dx.doi.org/10.1016/j.jviromet.2008.09.020
   PubMed Web of Science ®Google Scholar