Analysis and purification of IgG4 bispecific antibodies by a mixed-mode chromatography

Analytical Biochemistry

Volumn 484, Issue , 2015, Pages 173-179

  Yang, Xiaoyu ^a   Zhang, Ying ^a   Wang, Fengqiang ^a   Wang, Larry ^a   Richardson, Daisy ^a   Shameem, Mohammed ^a   Ambrogelly, Alexandre ^a,b  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Gilead Sciences   (United States)

Author keywords

Bispecific antibodies; Fab arm exchange; Half molecule exchange; IgG4; Mixed mode chromatography

Indexed keywords

ANTIBODIES; COLUMN CHROMATOGRAPHY; LIQUID CHROMATOGRAPHY; MASS SPECTROMETRY; MOLECULES; PURIFICATION;

ANALYTICAL METHOD; BIOCHEMICAL CHARACTERIZATION; CHROMATOGRAPHIC SEPARATIONS; IGG4; MIXED-MODE CHROMATOGRAPHY; PROTEIN FLUORESCENCE; QUANTITATIVE MONITORING; UV ABSORPTION;

CHEMICAL DETECTION;

ALBUMIN; BISPECIFIC ANTIBODY; IMMUNOGLOBULIN G4; PEMBROLIZUMAB; IMMUNOGLOBULIN G;

ANTIBODY DETECTION; ARTICLE; CHROMATOGRAPHY; COLUMN CHROMATOGRAPHY; ELUTION; FLUORESCENCE ANALYSIS; HUMAN; IMMUNOGLOBULIN BLOOD LEVEL; IN VITRO STUDY; LIMIT OF DETECTION; LIMIT OF QUANTITATION; MASS SPECTROMETRY; MIXED MODE CHROMATOGRAPHY; PRIORITY JOURNAL; PROTEIN PURIFICATION; QUANTITATIVE ASSAY; SERUM; IMMUNOLOGY; ISOLATION AND PURIFICATION; KINETICS; PROCEDURES;

ANTIBODIES, BISPECIFIC; CHROMATOGRAPHY; HUMANS; IMMUNOGLOBULIN G; KINETICS;

EID: 84933509168     PISSN: 00032697     EISSN: 10960309     Source Type: Journal    
DOI: 10.1016/j.ab.2015.06.014     Document Type: Article

References (33)

1. O.H. Brekke, and I. Sandlie Therapeutic antibodies for human diseases at the dawn of the twenty-first century Nat. Rev. Drug Discov. 2 2003 52 62
2. R. Jefferis Isotype and glycoform selection for antibody therapeutics Arch. Biochem. Biophys. 526 2012 159 166
3. G. Vidarsson, G. Dekkers, and T. Rispens IgG subclasses and allotypes: from structure to effector functions Front. Immunol. 5 2014 520
4. J. Wypych, M. Li, A. Guo, Z. Zhang, T. Martinez, M.J. Allen, S. Fodor, D.N. Kelner, G.C. Flynn, Y.D. Liu, P.V. Bondarenko, M.S. Ricci, T.M. Dillon, and A. Balland Human IgG2 antibodies display disulfide-mediated structural isoforms J. Biol. Chem. 283 2008 16194 16205
5. R. Abes, and J.L. Teillaud Modulation of tumor immunity by therapeutic monoclonal antibodies Cancer Metastasis Rev. 30 2011 111 124
6. C. Belda-Iniesta, I. Ibanez de Caceres, and J. de Castro Monoclonal antibodies for medical oncology: a few critical perspectives Clin. Transl. Oncol. 13 2011 84 87
7. D. Berman, A. Korman, R. Peck, D. Feltquate, N. Lonberg, and R. Canetta The development of immunomodulatory monoclonal antibodies as a new therapeutic modality for cancer: The Bristol-Myers Squibb experience Pharmacol. Ther. 2014
8. A.M. Scott, J.D. Wolchok, and L.J. Old Antibody therapy of cancer Nat. Rev. Cancer 12 2012 278 287
9. J. Schuurman, G.J. Perdok, A.D. Gorter, and R.C. Aalberse The inter-heavy chain disulfide bonds of IgG4 are in equilibrium with intra-chain disulfide bonds Mol. Immunol. 38 2001 1 8
10. D.R. Burton, and I.A. Wilson Immunology. Square-dancing antibodies Science 317 2007 1507 1508
11. T. Rispens, P. Ooijevaar-de Heer, O. Bende, and R.C. Aalberse Mechanism of immunoglobulin G4 Fab-arm exchange J. Am. Chem. Soc. 133 2011 10302 10311
12. A.F. Labrijn, A.O. Buijsse, E.T. van den Bremer, A.Y. Verwilligen, W.K. Bleeker, S.J. Thorpe, J. Killestein, C.H. Polman, R.C. Aalberse, J. Schuurman, J.G. van de Winkel, and P.W. Parren Therapeutic IgG4 antibodies engage in Fab-arm exchange with endogenous human IgG4 in vivo Nat. Biotechnol. 27 2009 767 771
13. M. van der Neut, J. Kolfschoten, M. Schuurman, W.K. Losen, P. Bleeker, E. Martinez-Martinez, T.H. den Vermeulen, L. Bleker, T. Wiegman, L.A. Vink, M.H. De Aarden, J.G. van de Baets, R.C. Winkel, and P.W. Aalberse Parren, Anti-inflammatory activity of human IgG4 antibodies by dynamic Fab arm exchange Science 317 2007 1554 1557
14. R.C. Aalberse, and J. Schuurman IgG4 breaking the rules Immunology 105 2002 9 19
15. J. Schuurman, R. Van Ree, G.J. Perdok, H.R. Van Doorn, K.Y. Tan, and R.C. Aalberse Normal human immunoglobulin G4 is bispecific: it has two different antigen-combining sites Immunology 97 1999 693 698
16. X. Yang, and A. Ambrogelly Enlarging the repertoire of therapeutic monoclonal antibodies platforms: domesticating half molecule exchange to produce stable IgG4 and IgG1 bispecific antibodies Curr. Opin. Biotechnol. 30 2014 225 229
17. J.W. Bloom, M.S. Madanat, D. Marriott, T. Wong, and S.Y. Chan Intrachain disulfide bond in the core hinge region of human IgG4 Protein Sci. 6 1997 407 415
18. S. Angal, D.J. King, M.W. Bodmer, A. Turner, A.D. Lawson, G. Roberts, B. Pedley, and J.R. Adair A single amino acid substitution abolishes the heterogeneity of chimeric mouse/human (IgG4) antibody Mol. Immunol. 30 1993 105 108
19. R.C. Aalberse, S.O. Stapel, J. Schuurman, and T. Rispens Immunoglobulin G4: an odd antibody Clin. Exp. Allergy 39 2009 469 477
20. J.M. Reichert Antibodies to watch in 2014 mAbs 6 2014 5 14
21. J.M. Reichert Marketed therapeutic antibodies compendium mAbs 4 2012 413 415
22. Z. An Monoclonal antibodies - a proven and rapidly expanding therapeutic modality for human diseases Protein Cell 1 2010 319 330
23. P. Carter Improving the efficacy of antibody-based cancer therapies Nat. Rev. Cancer 1 2001 118 129
24. A.F. Labrijn, T. Rispens, J. Meesters, R.J. Rose, T.H. den Bleker, S. Loverix, E.T. van den Bremer, J. Neijssen, T. Vink, I. Lasters, R.C. Aalberse, A.J. Heck, J.G. van de Winkel, J. Schuurman, and P.W. Parren Species-specific determinants in the IgG CH3 domain enable Fab-arm exchange by affecting the noncovalent CH3-CH3 interaction strength J. Immunol. 187 2011 3238 3246
25. J. Schuurman, Y.F. Graus, A.F. Labrijn, S. Ruuls, and P.W. Parren Opening the door to innovation mAbs 6 2014 812 819
26. A. Mullard FDA drug approvals Nature Rev. Drug Discov. 14 2015 2014 77 81
27. J.P. Silva, O. Vetterlein, J. Jose, S. Peters, and H. Kirby The S228P mutation prevents in vivo and in vitro IgG4 Fab-arm exchange as demonstrated using a combination of novel quantitative immunoassays and physiological matrix preparation J. Biol. Chem. 2015
28. E. Young, E. Lock, D.G. Ward, A. Cook, S. Harding, and G.L. Wallis Estimation of polyclonal IgG4 hybrids in normal human serum Immunology 142 2014 406 413
29. M.J. Gramer, E.T. VandenBremer, M.D. van Kampen, A. Kundu, P. Kopfmann, E. Etter, D. Stinehelfer, J. Long, T. Lannom, E.H. Noordergraaf, J. Gerritsen, A.F. Labrijn, J. Schuurman, P.H. van Berkel, and P.W. Parren Production of stable bispecific IgG1 by controlled Fab-arm exchange: scalability from bench to large-scale manufacturing by application of standard approaches mAbs 5 2013 962 973
30. A.F. Labrijn, J.I. Meesters, B.E. de Goeij, E.T. van den Bremer, J. Neijssen, M.D. van Kampen, K. Strumane, S. Verploegen, A. Kundu, M.J. Gramer, P.H. van Berkel, J.G. van de Winkel, J. Schuurman, and P.W. Parren Efficient generation of stable bispecific IgG1 by controlled Fab-arm exchange Proc. Natl. Acad. Sci. U.S.A. 110 2013 5145 5150
31. P. Orth, L. Xiao, L.D. Hernandez, P. Reichert, P.R. Sheth, M. Beaumont, X. Yang, N. Murgolo, G. Ermakov, E. DiNunzio, F. Racine, J. Karczewski, S. Secore, R.N. Ingram, T. Mayhood, C. Strickland, and A.G. Therien Mechanism of action and epitopes of Clostridium difficile toxin B-neutralizing antibody bezlotoxumab revealed by X-ray crystallography J. Biol. Chem. 289 2014 18008 18021
32. X. Mou, X. Yang, H. Li, A. Ambrogelly, and D.J. Pollard A high throughput ultra performance size exclusion chromatography assay for the analysis of aggregates and fragments of monoclonal antibodies Pharm. Process. 2 2014 141 156
33. K. Stubenrauch, U. Wessels, J.T. Regula, H. Kettenberger, J. Schleypen, and U. Kohnert Impact of molecular processing in the hinge region of therapeutic IgG4 antibodies on disposition profiles in cynomolgus monkeys Drug Metab. Dispos. 38 2010 84 91