12,289
Views
327
CrossRef citations to date
0
Altmetric
Report

Charge variants in IgG1

Isolation, characterization, in vitro binding properties and pharmacokinetics in rats

, , , , , , , , , , , , , , , , & show all
Pages 613-624 | Received 27 Aug 2010, Accepted 15 Aug 2010, Published online: 01 Nov 2010

References

  • Seiler FR, Gronski P, Kurrle R, Lüben G, Harthus HP, Ax W, et al. Monoclonal antibodies: their chemistry, functions and possible uses. Angew Chem Int Ed Engl 1985; 24:139 - 160
  • Cohen S. General structure and heterogeneity of immunoglobulins. Proc R Soc Lond B Biol Sci 1966; 166:114 - 123
  • Boswell CA, Deng R, Lin K, Putnam WS, Lei C, Theil FP, et al. Mrsny R, Daugherty A. In vitro-in vivo correlation of pharmacokinetics, pharmacodynamics and metabolism for antibody therapeutics. Proteins and Peptides: Pharmacokinetic, Pharmacodynamic and Metabolic Outcomes 2010; New York NY: Informa Healthcare 1 - 14
  • Ober RJ, Radu CG, Ghetie V, Ward ES. Differences in promiscuity for antibody-FcRn interactions across species: implications for therapeutic antibodies. Int Immunol 2001; 13:1551 - 1559
  • Carter P. Improving the efficacy of antibody-based cancer therapies. Nature Rev Cancer 2001; 1:118 - 129
  • Boonyaratanakornkit BB, Park CB, Clark DS. Pressure effects on intra- and intermolecular interactions within proteins. Biochem Biophys Acta 2002; 1595:235 - 249
  • Zhang W, Czupryn MJ. Free sulfhydryl in recombinant monoclonal antibodies. Biotechnol Prog 2002; 18:509 - 513
  • Collins K. Charge density-dependent strength of hydration and biological structure. Biophys J 1997; 72:65 - 76
  • Perkins M, Theiler R, Lunte S, Jeschke M. Determination of the origin of charge heterogeneity in a murine monoclonal antibody. Pharm Res 2000; 17:1110 - 1117
  • Harris RJ, Kabakoff B, Macchi FD, Shen FJ, Kwong MJ, Andya DS, et al. Identification of multiple sources of charge heterogeneity in a recombinant antibody. J Chromatogr B 2001; 752:233 - 245
  • Sidhu SS. Full-length antibodies on display. Nat Biotech 2007; 25:537 - 538
  • Carson KL. Flexibility—the guiding principle for antibody manufacturing. Nat Biotech 2005; 23:1054 - 1058
  • Harris RJ, Shire SJ, Winter C. Commercial manufacturing scale formulation and analytical characterization of therapeutic recombinant antibodies. Drug Dev Res 2004; 61:137 - 154
  • Wang W, Singh S, Zeng DL, King K, Nema S. Antibody structure, instability and formulation. J Pharm Sci 2007; 96:1 - 26
  • He XZ, Que AH, Mo JJ. Analysis of charge heterogeneities in mAbs using imaged CE. Electropheresis 2009; 30:714 - 722
  • Vlasak J, Ionescu R. Heterogeneity of monoclonal antibodies revealed by charge-sensitive methods. Curr Pharm Biotechnol 2008; 9:468 - 481
  • Chirino AJ, Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotech 2004; 22:1383 - 1391
  • Lyubarskay Y, Houde D, Woodard J, Murphy D, Mhatre R. Analysis of recombinant monoclonal antibody isoforms by electrospray ionization mass spectrometry as a strategy for streamlining characterization of recombinant monoclonal antibody charge heterogeneity. Anal Biochem 2006; 348:24 - 39
  • Zheng JY, Janis LJ. Influence of pH, buffer species and storage temperature on physicochemical stability of a humanized monoclonal antibody LA298. Int J Pharm 2006; 308:46 - 51
  • Chumsae C, Gaza-Bulseco G, Sun J, Liu H. Comparison of methionine oxidation in thermal stability and chemically stressed samples of a fully human monoclonal antibody. J Chromatogr B 2007; 850:285 - 294
  • Antes B, Amon S, Rizzi A, Wiederkum S, Kainer M, Szolar O, et al. Analysis of lysine clipping of a humanized lewis-Y specific IgG antibody and its relation to Fc-mediated effector function. J Chromatogr B 2007; 852:250 - 256
  • Huang L, Lu J, Wroblewski VJ, Beals JM, Riggin RM. In vivo deamidation characterization of monoclonal antibody by LC/MS/MS. Anal Chem 2005; 77:1432 - 1439
  • Andya JD, Maa YF, Costantino HR, Nguyen PA, Dasovich N, Sweeney TD, et al. The effect of formulation excipients on protein stability and aerosol performance of spray-dried powders of a recombinant humanized anti-IgE monoclonal antibody. Pharm Res 1999; 16:350 - 358
  • Wypych J, Li M, Guo A, Zhang Z, Martinez T, Allen MJ, et al. Human IgG2 antibodies display disulfide-mediated structural isoforms. J Biol Chem 2008; 283:16194 - 16205
  • Dillon TM, Ricci MS, Vezina C, Flynn GC, Liu YD, Rehder DS, et al. Structural and functional characterization of disulfide isoforms of the human IgG2 subclass. J Biol Chem 2008; 283:16206 - 16215
  • Wright A, Morrison SL. Effect of C2-associated carbohydrate structure on Ig effector function: studies with chimeric mouse-human IgG1 antibodies in glycosylation mutants of Chinese hamster ovary cells. J Immunol 1998; 160:3393 - 3402
  • Johnson KA, Paisley-Flango K, Tangarone BS, Porter TJ, Rouse JC. Cation exchange-HPLC and mass spectrometry reveal C-terminal amidation of an IgG1 heavy chain. Anal Biochem 2007; 360:75 - 83
  • Pan H, Chen K, Chu L, Kinderman F, Apostol I, Huang G. Methionine oxidation in human IgG2 Fc decreases binding affinities to protein A and FcRn. Protein Sci 2009; 18:424 - 433
  • Sharifi J, Khawli LA, Hornick JL, Epstein AL. Improving monoclonal antibody pharmacokinetics via chemical modification. Q J Nucl Med 1998; 42:242 - 249
  • Igawa T, Tsunoda H, Tachibana T, Maeda A, Mimoto F, Moriyama C, et al. Reduced elimination of IgG antibodies by engineering the variable region. Protein Eng Des Sel 2010; 23:385 - 392
  • McLennan DN, Porter CJH, Charman SA. Subcutaneous drug delivery and the role of the lymphatics. Drug Discovery Today: Technologies 2005; 2:89 - 96
  • Schmid-Schonbein GW. Microlymphatics and lymph flow. Physiol Rev 1990; 70:987 - 1028
  • Kabat EA, Wu TT, Perry HM, Gottesman KS, Foeller C. Sequences of Proteins of Immunological Interest 9:Fifth Edition Bethesda United States Public Health Service, National Institutes of Health 3243 Publication Number 1991
  • Martin WL, Bjorkman PJ. Characterization of the 2:1 complex between the class I MHC-related Fc receptor and its Fc ligand in solution. Biochem 1999; 38:12639 - 12647
  • Roopenian DC, Akilesh S. FcRn: the neonatal Fc receptor comes of age. Nat Rev Immunol 2007; 7:715 - 725
  • O'Connor SW, Bale WF. Accessibility of circulating immunoglobulin G to the extravascular compartment of solid rat tumors. Cancer Res 1984; 44:3719 - 3723
  • Goldenberg NM, Steinberg BE. Surface charge: A key determinant of protein localization and function. Cancer Res 2010; 70:1277 - 1280
  • Khawli LA, Epstein AL. Exploration of novel strategies to enhance monoclonal antibodies targeting. Q J Nucl Med 1997; 41:25 - 35
  • Boswell CA, Sun X, Niu W, Weisman GR, Wong EH, Rheingold AL, et al. Comparative in vivo stability of copper-64-labeled cross-bridged and conventional tetraazamacrocyclic complexes. J Med Chem 2004; 47:1465 - 1474
  • Boswell CA, Brechbiel MW. Development of radioimmunotherapeutic and diagnostic antibodies: an inside-out view. Nucl Med Biol 2007; 34:757 - 778
  • Gangopadhyay A, Petrick AT, Thomas P. Modification of antibody isoelectric point affects biodistribution of 111-indium-labeled antibody. Nucl Med Biol 1996; 23:257 - 261
  • ten Kate CI, Fischman AJ, Rubin RH, Fucello AJ, Riexinger D, Wilkinson RA, et al. Effect of isoelectric point on biodistribution and inflammation: imaging with indium-111-labelled IgG. Eur J Nucl Med 1990; 17:305 - 309
  • Perera RM, Zoncu R, Johns TG, Pypaert M, Lee FT, Mellman I, Lloyd JO, et al. Internalization, intracellular trafficking and biodistribution of monoclonal antibody 806: a novel anti-epidermal growth factor receptor antibody. Neoplasia 2007; 9:1099 - 1110
  • Hong G, Bazin-Redureau MI, Scherrmann JM. Pharmacokinetics and organ distribution of cationized colchicine-specific IgG and Fab fragments in rat. J Pharm Sci 1999; 88:147 - 153
  • Lee HJ, Pardridge WM. Monoclonal antibody radiopharmaceuticals: cationization, pegylation, radiometal chelation, pharmacokinetics and tumor imaging. Bioconjug Chem 2003; 14:546 - 553
  • Pardridge WM, Kang YS, Diagne A, Zack JA. Cationized hyperimmune immunoglobulins: pharmacokinetics, toxicity evaluation and treatment of human immunodeficiency virus-infected human-peripheral blood lymphocytes-severe combined immune deficiency mice. J Pharmacol Exp Ther 1996; 276:246 - 252
  • Bickel U, Lee VMY, Pardridge WM. Pharmacokinetic differences between 111In- and 125I-labeled cationized monoclonal antibody against b-amyloid in mouse and dog. Drug Delivery 1995; 2:128 - 135
  • Khawli LA, Glasky MS, Alauddin MM, Epstein AL. Improved tumor localization and radioimaging with chemically modified monoclonal antibodies. Cancer Biother Radiopharm 1996; 11:203 - 215
  • Khawli LA, Mizokami MM, Sharifi J, Hu P, Epstein AL. Pharmacokinetic characteristics and biodistribution of radioiodinated chimeric TNT-1, -2 and -3 antibodies modified with biotin. Cancer Biother Radiopharm 2002; 17:359 - 370
  • Iznaga-Escobar N, Mishra AK, Perez-Rodriguez R. Factors affecting pharmacokinetics of monoclonal antibodies: a review article. Meth Find Exp Clin Pharmacol 2004; 26:123 - 127
  • Epstein AL, Khawli LA, Hu P. Torchilin V, Muzykantov A. Tumor necrosis treatment and imaging of solid tumors. Biomedical Aspects of Drug Targeting 2003; New Rochelle, NY Mary Ann Liebert 249 - 274
  • Winkelhake JL. Effects of chemical modification of antibodies on their clearance from the circulation. J Bio Chem 1977; 252:1865 - 1868
  • Torchilin VP, Klabanov AL, Nossiff ND, Slinkin MA, Strauss HW, Haber E, et al. Monoclonal antibody modification with chelate-linked high molecular weight polymers: major increases in polyvalent cation binding without loss of antigen binding. Hybridoma 1987; 6:229 - 240
  • Rodwell JD, Alvarez VL, Lee C, Lopes AD, Goers JW, King HD, et al. Site-specific covalent modification of monoclonal antibodies: in vitro and in vivo evaluations. Proc Natl Acad Sci USA 1986; 83:2632 - 2636
  • Petkova SB, Akilesh S, Sproule TJ, Christianson GJ, Khabbaz HA, Brown AC, et al. Enhanced half-life of genetically engineered human IgG1 antibodies in a humanized FcRn mouse model: potential application in humorally mediated autoimmune disease. Int Immunol 2006; 18:1759 - 1769
  • Shields RL, Namenuk AK, Hong K, Meng YG, Rae J, Briggs J, et al. High resolution mapping of the binding site on Human IgG1 for FcγRI, FcγRII, FcγRIII and FcRn and design of IgG1 variants with improved binding to the FcγR. J Biol Chem 2001; 276:6591 - 6604
  • Jones AJS, Papac DI, Chin EH, Keck R, Baughman SA, Lin YS, et al. Selective clearance of glycoforms of a complex glycoprotein pharmaceutical caused by terminal N-acetylglucosamine is similar in humans and cynomolgus monkeys. Glycobiology 2007; 17:529 - 540
  • Sondermann P, Oosthuizen V. Mediation and Modulation of Antibody Function. Biochem Soc Transacti 2002; 30:481 - 486
  • Yeung YA, Leabman MK, Marvin JS, Qiu J, Adams CW, Lien S, et al. Engineering human IgG1 affinity to human nonatal Fc receptor: impact of affinity improvement on pharmacokinetics in primates. J Immunol 2009; 182:7663 - 7671
  • Wang E, Brown PS, Aroeti B, Chapin SJ, Mostov KE, Dunn KW. Apical and basolateral endocytic pathways of MDCK cells meet in acidic common endosomes distinct from a nearly-neutral apical recycling endosome. Traffic 2000; 1:480 - 493
  • Tang L, Persky AM, Hochhaus G, Meibohm B. Pharmacokinetic aspects of biotechnology products. J Pharm Sci 2004; 93:2184 - 2204
  • Muchmore EA, Varki NM, Fukuda M, Varki A. Developmental regulation of sialic acid modifications in rat and human colon. FASEB J 1987; 1:229 - 235
  • Onda M, Kreitman RJ, Vasmatzis G, Lee B, Pastan I. Reduction of the non-specific animal toxicity of anti-Tac(Fv)-PE38 by mutations in the framework regions of the Fv which lower the isolelectric point. J Immunol 1999; 163:6072 - 6077
  • Putnam WS, Prabhu S, Zheng Y, Subramanyam M, Wang YMC. Pharmacokinetic, pharmacodynamic and immunogenicity comparability assessment strategies for monoclonal antibodies. Trends Biotechnol 2010; 28:509 - 516
  • Meert C, Guo A, Novick S, Han M, Pettit D, Balland A. Evaluation of pI marker Sources for cIEF characterization of a therapeutic antibody. Chromatographia 2007; 66:963 - 968
  • Wu J, Huang T. Peak identification in capillary isoelectric focusing using the concept of relative peak position as determined by two isoelectric point markers. Electrophoresis 2006; 27:3584 - 3590
  • Eaton DL, Wood WI, Eaton D, Hass PE, Hollingshead P, Wion K, et al. Construction and characterization of an active factor VIII variant lacking the central one-third of the molecule. Biochem 1986; 25:8343 - 8347

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.