Entanglement model of antibody viscosity

Journal of Physical Chemistry B

Volumn 118, Issue 19, 2014, Pages 5044-5049

  Schmit, Jeremy D ^a   He, Feng ^b   Mishra, Shradha ^a,c   Ketchem, Randal R ^b   Woods, Christopher E ^b   Kerwin, Bruce A ^b  

^a KANSAS STATE UNIVERSITY   (United States)

^b AMGEN INC   (United States)

^c S N BOSE NATIONAL CENTRE FOR BASIC SCIENCES   (India)

Author keywords

[No Author keywords available]

Indexed keywords

ASSOCIATION REACTIONS; VISCOSITY;

ANTIBODY MOLECULES; CONCENTRATION DEPENDENCE; GLOBULAR PROTEINS; INTER-PARTICLE INTERACTION; LINEAR POLYMERS; MOLECULAR ENTANGLEMENTS; POWER LAW REGIME; VARIABLE DOMAIN;

ANTIBODIES;

ANTIGEN ANTIBODY COMPLEX; IMMUNOGLOBULIN G; MONOCLONAL ANTIBODY; PROTEIN AGGREGATE; PROTEIN BINDING; SOLUTION AND SOLUBILITY; STREPTAVIDIN;

ANTIGEN ANTIBODY COMPLEX; CHEMICAL MODEL; CHEMISTRY; KINETICS; SOLUTION AND SOLUBILITY; THERMODYNAMICS; VISCOSITY; YOUNG MODULUS;

ANTIBODIES, MONOCLONAL; ANTIGEN-ANTIBODY COMPLEX; ELASTIC MODULUS; IMMUNOGLOBULIN G; KINETICS; MODELS, CHEMICAL; PROTEIN AGGREGATES; PROTEIN BINDING; SOLUTIONS; STREPTAVIDIN; THERMODYNAMICS; VISCOSITY;

EID: 84900564112     PISSN: 15206106     EISSN: 15205207     Source Type: Journal    
DOI: 10.1021/jp500434b     Document Type: Article

References (38)

1. Shire, S. J. Formulation and Manufacturability of Biologics Curr. Opin. Biotechnol. 2009, 20, 708-714
2. Jezek, J.; Rides, M.; Derham, B.; Moore, J.; Cerasoli, E.; Simler, R.; Perez-Ramirez, B. Viscosity of Concentrated Therapeutic Protein Compositions Adv. Drug Delivery Rev. 2011, 63, 1107-1117
3. Saito, S.; Hasegawa, J.; Kobayashi, N.; Kishi, N.; Uchiyama, S.; Fukui, K. Behavior of Monoclonal Antibodies: Relation Between the Second Virial Coefficient (B (2)) at Low Concentrations and Aggregation Propensity and Viscosity at High Concentrations Pharm. Res. 2012, 29, 397-410
4. Guo, Z.; Chen, A.; Nassar, R. A.; Helk, B.; Mueller, C.; Tang, Y.; Gupta, K.; Klibanov, A. M. Structure-Activity Relationship for Hydrophobic Salts as Viscosity-Lowering Excipients for Concentrated Solutions of Monoclonal Antibodies Pharm. Res. 2012, 29, 3102-3109
5. Yadav, S.; Shire, S. J.; Kalonia, D. S. Viscosity Behavior of High-Concentration Monoclonal Antibody Solutions: Correlation with Interaction Parameter and Electroviscous Effects J. Pharm. Sci. 2012, 101, 998-1011
6. Connolly, B. D.; Petry, C.; Yadav, S.; Demeule, B.; Ciaccio, N.; Moore, J. M. R.; Shire, S. J.; Gokarn, Y. R. Weak Interactions Govern the Viscosity of Concentrated Antibody Solutions: High-Throughput Analysis Using the Diffusion Interaction Parameter Biophys. J. 2012, 103, 69-78
7. Du, W.; Klibanov, A. M. Hydrophobic Salts Markedly Diminish Viscosity of Concentrated Protein Solutions Biotechnol. Bioeng. 2011, 108, 632-636
8. He, F.; Woods, C. E.; Litowski, J. R.; Roschen, L. A.; Gadgil, H. S.; Razinkov, V. I.; Kerwin, B. A. Effect of Sugar Molecules on the Viscosity of High Concentration Monoclonal Antibody Solutions Pharm. Res. 2011, 28, 1552-1560
9. 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, 1152-1168
10. 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. 2009, 26, 2607-2618
11. Kanai, S.; Liu, J.; Patapoff, T. W.; Shire, S. J. ReversibleSelf- Association of a Concentrated Monoclonal Antibody Solution Mediated by Fab-Fab Interaction that Impacts Solution Viscosity J. Pharm. Sci. 2008, 97, 4219-4227
12. 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
13. 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
14. He, F.; Woods, C. E.; Trilisky, E.; Bower, K. M.; Litowski, J. R.; Kerwin, B. A.; Becker, G. W.; Narhi, L. O.; Razinkov, V. I. Screening of Monoclonal Antibody Formulations Based on High-throughput Thermostability and Viscosity Measurements: Design of Experiment and Statistical Analysis J. Pharm. Sci. 2011, 100, 1330-1340
15. Yadav, S.; Sreedhara, A.; Kanai, S.; Liu, J.; Lien, S.; Lowman, H.; Kalonia, D. S.; Shire, S. J. Establishing a Link Between Amino Acid Sequences and Self-associating and Viscoelastic Behavior of Two Closely Related Monoclonal Antibodies Pharm. Res. 2011, 28, 1750-1764
16. Monkos, K.; Turczynski, B. A Comparative Study on Viscosity of Human, Bovine and Pig IgG Immunoglobulins in Aqueous Solutions Int. J. Biol. Macromol. 1999, 26, 155-159
17. 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
18. Minton, A. P. Hard Quasispherical Particle Models for the Viscosity of Solutions of Protein Mixtures J. Phys. Chem. B 2012, 116, 9310-9315
19. Santamaría-Holek, I.; Mendoza, C. I. The Rheology of Concentrated Suspensions of Arbitrarily-shaped Particles J. Colloid Interface Sci. 2010, 346, 118-126
20. Yadav, S.; Laue, T. M.; Kalonia, D. S.; Singh, S. N.; Shire, S. J. The Influence of Charge Distribution on Self-Association and Viscosity Behavior of Monoclonal Antibody Solutions Mol. Pharmacol. 2012, 9, 791-802
21. Monkos, K. Viscometric Study of Human, Bovine, Equine and Ovine Haemoglobin in Aqueous Solution Int. J. Biol. Macromol. 1994, 16, 31-35
22. Monkos, K. Viscosity of Bovine Serum Albumin Aqueous Solutions as a Function of Temperature and Concentration Int. J. Biol. Macromol. 1996, 18, 61-68
23. Monkos, K. Concentration and Temperature Dependence of Viscosity in Lysozyme Aqueous Solutions Biochim. Biophys. Acta, Protein Struct. 1997, 1339, 304-310
24. Monkos, K. Viscosity Analysis of the Temperature Dependence of the Solution Conformation of Ovalbumin Biophys. Chem. 2000, 85, 7-16
25. de Gennes, P.-G. Scaling Concepts in Polymer Physics; Cornell University Press: Ithaca, NY, 1979.
26. Zarraga, I. E.; Taing, R.; Zarzar, J.; Luoma, J.; Hsiung, J.; Patel, A.; Lim, F. J. High Shear Rheology and Anisotropy in Concentrated Solutions of Monoclonal Antibodies J. Pharm. Sci. 2013, 102, 2538-2549
27. Rubinstein, M.; Colby, R. H. Polymer Physics (Chemistry); Oxford University Press: Oxford, U.K., 2003.
28. De Gennes, P. G. Dynamics of Entangled Polymer Solutions. I. The Rouse Model Macromolecules 1976, 9, 587-593
29. De Gennes, P. G. Dynamics of Entangled Polymer Solutions. II. Inclusion of Hydrodynamic Interactions Macromolecules 1976, 9, 594-598
30. Doi, M.; Edwards, S. F. The Theory of Polymer Dynamics(International Series of Monographs on Physics); Oxford University Press: Oxford, U.K., 1988.
31. Cates, M. E. Reptation of Living Polymers: Dynamics of Entangled Polymers in the Presence of Reversible Chain-Scission Reactions Macromolecules 1987, 20, 2289-2296
32. Cates, M. Dynamics of Living Polymers and Flexible Surfactant Micelles: Scaling Laws for Dilution J. Phys. (Paris) 1988, 49, 1593-1600
33. He, F.; Becker, G. W.; Litowski, J. R.; Narhi, L. O.; Brems, D. N.; Razinkov, V. I. High-throughput Dynamic Light Scattering Method for Measuring Viscosity of Concentrated Protein Solutions Anal. Biochem. 2010, 399, 141-143
34. Samra, H. S.; He, F. Advancements in High Throughput BiophysicalTechnologies: Applications for Characterization and Screening During Early Formulation Development of Monoclonal Antibodies Mol. Pharmacol. 2012, 9, 696-707
35. 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 Protein Concentration Solutions Using a Model Monoclonal Antibody (IgG2) J. Pharm. Sci. 2006, 95, 1967-1983
36. Yadav, S.; Shire, S. J.; Kalonia, D. S. Factors Affecting theViscosity in High Concentration Solutions of Different Monoclonal Antibodies J. Pharm. Sci. 2010, 99, 4812-4829
37. Grimsley, G. R.; Scholtz, J. M.; Pace, C. N. A Summary of theMeasured pK Values of the Ionizable Groups in Folded Proteins Protein Sci. 2009, 18, 247-251
38. Graessley, W. W. The Entanglement Concept in Polymer Rheology; Advances in Polymer Science; Springer-Verlag: Berlin and Heidelberg, Germany, 1974; Vol. 16.