Fc domain mediated self-association of an IgG1 monoclonal antibody under a low ionic strength condition

Journal of Bioscience and Bioengineering

Volumn 112, Issue 4, 2011, Pages 326-332

  Nishi, Hirotaka ^a,b   Miyajima, Makoto ^a   Wakiyama, Naoki ^a   Kubota, Kei ^a   Hasegawa, Jun ^a   Uchiyama, Susumu ^b   Fukui, Kiichi ^b  

^a DAIICHI SANKYO CO   (Japan)

^b OSAKA UNIVERSITY   (Japan)

Author keywords

Dynamic light scattering (DLS); Fc Fc interaction; Isothermal titration calorimetry (ITC); Liquid liquid phase separation; Low ionic strength condition; Monoclonal antibody; Protein self association; Surface plasmon resonance (SPR)

Indexed keywords

FC-FC INTERACTION; ISOTHERMAL TITRATION CALORIMETRY (ITC); LIQUID-LIQUID PHASE SEPARATION; LOW IONIC STRENGTH CONDITION; SURFACE PLASMON RESONANCE (SPR);

ASSOCIATION REACTIONS; CALORIMETRY; DYNAMIC LIGHT SCATTERING; LIQUIDS; MONOCLONAL ANTIBODIES; PHASE SEPARATION; PIPE FLOW; SURFACE PLASMON RESONANCE; TITRATION; ZETA POTENTIAL;

IONIC STRENGTH;

IMMUNOGLOBULIN F(AB) FRAGMENT; IMMUNOGLOBULIN FC FRAGMENT; IMMUNOGLOBULIN G1 ANTIBODY; MONOCLONAL ANTIBODY;

ANTIGEN BINDING; ARTICLE; CONTROLLED STUDY; DISSOCIATION; ENTHALPY; HEAT; HYDRODYNAMICS; IONIC STRENGTH; ISOTHERMAL TITRATION CALORIMETRY; LIQUID; MOLECULAR INTERACTION; PH; PHASE SEPARATION; PROTEIN DEGRADATION; PROTEIN DOMAIN; STATIC ELECTRICITY; ZETA POTENTIAL;

ANTIBODIES, MONOCLONAL, HUMANIZED; IMMUNOGLOBULIN FAB FRAGMENTS; IMMUNOGLOBULIN FC FRAGMENTS; IMMUNOGLOBULIN G; OSMOLAR CONCENTRATION;

EID: 80054023428     PISSN: 13891723     EISSN: 13474421     Source Type: Journal    
DOI: 10.1016/j.jbiosc.2011.06.017     Document Type: Article

References (42)

1. Reichert J.-M. Monoclonal antibodies as innovative therapeutics. Curr. Pharm. Biotechnol. 2008, 9:423-430.
2. Braun A., Kwee L., Labow M.-A., Alsenz J. Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (INF-alpha) in normal and transgenic mice. Pharm. Res. 1997, 14:1472-1478.
3. Hermeling S., Crommelin D.-J., Schellekens H., Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins. Pharm. Res. 2004, 21:897-903.
4. Demeule B., Lawrence M.-J., Drake A.-F., Gurny R., Arvinte T. Characterization of protein aggregation: the case of a therapeutic immnoglobulin. Biochem. Biophys. Acta 2007, 1774:146-153.
5. Liu J., Nguyen M.-D.-H., Andya J.-D., Shire S.-J. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J. Pharm. Sci. 2005, 94:1928-1940.
6. Salinas B.-A., Sathish H.-A., Bishop S.-M., Harn N., Carpenter J.-F., Randolph T.-W. Understanding and modulating opalescence and viscosity in a monoclonal antibody formulation. J. Pharm. Sci. 2010, 99:82-93.
7. Yadav S., Liu J., Shire S.-J., Kalonia D.-S. Specific interactions in high concentration antibody solutions resulting in high viscosity. J. Pharm. Sci. 2010, 99:1151-1168.
8. Nezlin R. Interactions between immunoglobulin G molecules. Immunol. Lett. 2010, 132:1-5.
9. Minton A.-P. Molecular crowding: analysis of effects of high concentrations of inert consolutes on biochemical equilibria and rates in terms of volume exclusion. Methods Enzymol. 1998, 295:127-149.
10. Jiménez M., Rivas G., Minton A.-P. Quantitative characterization of weak self-association in concentrated solutions of immunoglobulin G via the measurement of sedimentation equilibrium and osmotic pressure. Biochemistry 2007, 46:8373-8378.
11. Shire S.-J., Shahrokh Z., Liu J. Challenges in the development of high protein concentration formulations. J. Pharm. Sci. 2004, 93:1390-1402.
12. Kanai S., Liu J., Patapoff T.W., Shire S.J. Reversible self-association of a concentrated monoclonal antibody solution mediated by Fab-Fab interaction that impacts solution viscosity. J. Pharm. Sci. 2008, 97:4219-4227.
13. Yagi H., Takahashi N., Yamaguchi Y., Kato K. Temperature-dependent isologous Fab-Fab interaction that mediates cryocrystallization of a monoclonal immunoglobulin G. Mol. Immunol. 2004, 41:1211-1215.
14. Robert D., Barelli S., Crettaz D., Bart P.-A., Schifferli J.-A., Betticher D., Tissot J.-D. Clinical proteomics: study of a cryogel. Proteomics 2006, 6:3958-3960.
15. Nishi H., Miyajima M., Nakagami H., Noda M., Uchiyama S., Fukui K. Phase separation of an IgG1 antibody solution under a low ionic strength condition. Pharm. Res. 2010, 27:1348-1360.
16. Mason B.-D., Zhang-van Enk J., Zhang L., Remmele R.-L., Zhang J. Liquid-liquid phase separation of a monoclonal antibody and nonmonotonic influence of Hofmeister anions. Biophys. J. 2010, 99:3792-3800.
17. Chari R., Jerath K., Badkar A.-V., Kalonia D.-S. Long- and short-range electrostatic interactions affect the rheology of highly concentrated antibody solutions. Pharm. Res. 2010, 26:2607-2618.
18. Narayanan J., Liu X.-Y. Protein interactions in undersaturated and supersaturated solutions: a study using light and X-ray scattering. Biophys. J. 2003, 84:523-532.
19. Saluja A., Badkar A.-V., Zeng D.-L., Nema S., Kalonia D.-S. Application of high-frequency rheology measurements for analyzing protein-protein interactions in high concentration solutions using a model antibody (IgG2). J. Pharm. Sci. 2006, 95:1967-1983.
20. Saluja A., Badkar A.-V., Zeng D.-L., Nema S., Kalonia D.-S. Ultrasonic storage modulus as a novel parameter for analyzing protein-protein interactions in high protein concentration solutions: correlation with static and dynamic light scattering measurements. Biophys. J. 2007, 92:234-244.
21. Saluja A., Kalonia D.-S. Application of ultrasonic shear rheometer to characterize rheological properties of high concentration solutions at microliter volume. J. Pharm. Sci. 2005, 94:1161-1168.
22. Saluja A., Badkar A.-V., Zeng D.-L., Kalonia D.-S. Ultrasonic rheology of a monoclonal antibody (IgG2) solution: implications for physical stability of proteins in high concentration formulations. J. Pharm. Sci. 2007, 96:3181-3195.
23. Patel A.-R., Kerwin B.-A., Kanapuram S.-R. Viscoelastic characterization of high concentration antibody formulations using quartz crystal microbalance with dissipation monitoring. J. Pharm. Sci. 2009, 98:3108-3116.
24. Velazquez-Campoy A., Leavitt S.-A., Freire E. Characterization of protein-protein interactions by isothermal titration calorimetry. Methods Mol. Biol. 2004, 261:35-54.
25. Alford J.-R., Kwok S.-C., Roberts J.-N., Wuttke D.-S., Kendrick B.-S., Carpenter J.-F., Randolph T.-W. High concentration formulations of recombinant human Interleukin-1 receptor antagonist: I. Physical characterization. J. Pharm. Sci. 2008, 97:3035-3050.
26. Lakshminarayanan R., Yoon I., Hedge B.-G., Fan D., Du C., Moradian-Oldak J. Analysis of secondary structure and self-assembly of amelogenin by variable temperature circular dichroism and isothermal titration calorimetry. Proteins 2009, 76:560-569.
27. Stubenrauch K., Wessels U., Vogel R., Schleypen J. Evaluation of a biosensor immunoassay for simultaneous characterization of isotype and binding region of human anti-tocilizumab antibodies with control by surrogate standards. Anal. Biochem. 2009, 390:189-196.
28. Jion A.-I., Goh L.-T., Oh S.-K.-W. Crystallization of IgG1 by mapping its liquid-liquid phase separation curve. Biotechnol. Bioeng. 2006, 95:911-918.
29. Ahamed T., Esteban B.-N.-A., Ottens M., van Dedem G.-W., van der Wielen L.-A., Bisschops M.-A.-T., Lee A., Pham C., Thömmes J. Phase behavior of an intact monoclonal antibody. Biophys. J. 2007, 93:610-619.
30. Dumets A.-C., Chockla A.-M., Kaler E.-W., Lenhoff A.-M. Protein phase behavior in aqueous solutions: crystallization, liquid-liquid phase separation, gels, and aggregates. Biophys. J. 2008, 94:570-583.
31. George A., Wilson W.-W. Predicting protein crystallization from a dilute solution property. Acta Crystallogr. 1994, D50:61-365.
32. George A., Chiang Y., Guo B., Arabshahi A., Cai Z., Wilson W.-W. Second virial coefficient as predictor in protein crystal growth. Methods Enzymol. 1997, 276:100-110.
33. Tanaka T., Ishimoto C. Phase separation of a protein-water mixture in cold cataract in the young rat lens. Science 1977, 197:1010-1012.
34. Ishimoto C., Tanaka T. Critical behavior of a binary mixture of protein and salt water. Phys. Rev. Lett. 1977, 39:474-477.
35. Clark J.-I., Clark J.-M. Lens cytoplasmic phase separation. Int. Rev. Cytol. 2000, 192:171-187.
36. Tankersley D.-L., Preston M.-S., Finlayson J.-S. Immunoglobulin D dimer: an idiotype-anti-idiotype complex. Mol. Immunol. 1988, 25:41-48.
37. Chennamsetty N., Helk B., Voynov V., Kayser V., Trout B.-L. Aggregation-prone motifs in human immunoglobulin. J. Mol. Biol. 2009, 391:404-413.
38. Chennamsetty N., Voynov V., Kayser V., Helk B., Trout B.-L. Design of therapeutic proteins with enhanced stability. Proc. Natl. Acad. Sci. USA 2009, 106:11937-11942.
39. Easterbrook-Smith S.-B., Vandenberg R.-J., Alden J.-R. The role of Fc:Fc interactions in insoluble immune complex formation and complement activation. Mol. Immunol. 1988, 25:1331-1337.
40. Rispense T., Heer P.-O.-D., Vermeulen E., Schuurman J., Kolfschoten M.-N., Aalberse R. Human IgG4 binds to IgG4 and conformationally altered IgG1 via Fc-Fc interactions. J. Immunol. 2009, 182:4275-4281.
41. Kolenko P., Dohnalác J., Dušková J., Skálová T., Collard R., Hašek J. New insights into intra- and intermolecular interactions of immunoglobulins: crystal structure of mouse IgG2b-Fc at 2.1-Å resolution. Immunology 2009, 126:378-383.
42. Obert E., Bellot M., Bouteiller L., Andrioletti F., Lehen-Ferrenbach C., Boué F. Both water- and organo-soluble supramolecular polymer stabilized by hydrogen-bonding and hydrophobic interactions. J. Am. Chem. Soc. 2007, 129:15601-15605.