Viscoelastic characterization of high concentration antibody formulations using quartz crystal microbalance with dissipation monitoring

Journal of Pharmaceutical Sciences

Volumn 98, Issue 9, 2009, Pages 3108-3116

  Patel, Ankit R ^a,c   Kerwin, Bruce A ^b   Kanapuram, Sekhar R ^b  

^a Stanford University   (United States)

^b AMGEN INC   (United States)

^c GENENTECH INC   (United States)

Author keywords

Adsorbed protein films; High concentration antibody formulations; Loss modulus; Protein adsorption; QCM D; Quartz crystal microbalance with dissipation monitoring; Storage modulus; Tan delta; Ultrasonic rheology; Viscoelastic properties

Indexed keywords

IMMUNOGLOBULIN G2; MONOCLONAL ANTIBODY;

ARTICLE; DRUG FORMULATION; FLOW KINETICS; PH; PROTEIN PROTEIN INTERACTION; QUARTZ CRYSTAL MICROBALANCE; ULTRASOUND; VISCOELASTICITY;

EID: 68949093728     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21610     Document Type: Article

References (28)

1. Shire SJ, Shahrokh Z, Liu J. 2004. Challenges in the development of high protein concentration formulations. J Pharm Sci 93:1390-1402. (Pubitemid 38725014)
2. Harn N, Allan C, Oliver C, Middaugh CR. 2007. Highly concentrated monoclonal antibody solutions: Direct analysis of physical structure and thermal stability. J Pharm Sci 96:532-546. (Pubitemid 46466076)
3. Liu J, Nguyen MDH, Andya JD, Shire SJ. 2005. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J Pharm Sci 94:1928-1940. (Pubitemid 41551477)
4. Kerwin BA, Chang BS, Gegg CV, Gonnelli M, Li T, Strambini GB. 2002. Interactions between PEG and type I soluble tumor necrosis factor receptor: Modulation by pH and by PEGylation at the N-terminus. Protein Sci 11:1825-1833. (Pubitemid 34663561)
5. Monkos K. 2005. A comparison of solution conformation and hydrodynamic properties of equine, porcine, and rabbit serum albumin using viscosity measurements. Biochim Biophys Acta 1748:100-109. (Pubitemid 40332185)
6. Monkos K. 2000. Viscosity analysis of the temperature dependence of the solution conformation of ovalbumin. Biophys Chem 85:7-16. (Pubitemid 30314649)
7. Monkos K. 1997. Concentration and temperature dependence of viscosity in lysozyme aqueous solutions. Biochim Biophys Acta 1339:304-310. (Pubitemid 27220256)
8. Monkos K. 1996. Viscosity of bovine serum albumin aqueous solutions as a function of temperature and concentration. Int J Biol Macromol 18:61-68. (Pubitemid 26070469)
9. Saluja A, Kalonia DS. 2005. Application of ultrasonic shear rheometer to characterize rheological properties of high protein concentration solutions at microliter volume. J Pharm Sci 94:1161-1168. (Pubitemid 40904181)
10. Saluja A, Badkar AV, Zeng DL, Kalonia DS. 2007. Ultrasonic rheology of a monoclonal antibody (IgG2) solution: Implications for physical stability of proteins in high concentration formulations. J Pharm Sci 96:3181-3195.
11. Lonetti B, Fratini E, Chen SH, Baglioni P. 2004. Viscoelastic and small angle neutron scattering studies of concentrated protein solutions. Phys Chem Chem Phys 6:1388-1395.
12. Saluja A, Kalonia DS. 2004. Measurement of fluid viscosity at microliter volumes using quartz impedance analysis. AAPS Pharm Sci Tech 5:47. (Pubitemid 41086239)
13. Saluja A, Badkar AV, Zeng DL, Nema S, Kalonia DS. 2006. Application of high-frequency rheology measurements for analyzing protein-protein interactions in high concentration solutions using a model monoclonal antibody (IgG2). J Pharm Sci 95:1967-1983. (Pubitemid 44433028)
14. Saluja A, Badkar Av, Zeng DL, Nema S, Kalonia DS. 2006. 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 92:1-11. (Pubitemid 46048431)
15. Kanazawa KK, Gordon JG. 1985. Frequency of a quartz microbalance in contact with liquid. Anal Chem 57:1770-1771.
16. Sauerbrey G. 1959. Verwendung von schwingquarzen zur wagung dunner schichten und zur mikrowagung. Zeitschrift fur Physik 155:206-222.
17. Rodahl M, Hook F, Krozer A, Brzezinski P, Kasemo B. 1995. Quartz crystal microbalance setup for frequency and Q-factor measurements in gaseous and liquid environments. Rev Sci Instrum66:3924-3930.
18. Rodahl M, Kasemo B. 1996. On the measurement of thin liquid overlayers with the quartz-crystal microbalance. Sensor Actuator A Phys 54:448-456. (Pubitemid 126356992)
19. Reed CE, Kanazawa KK, Kaufman JH. 1990. Physical description of a viscoelastically loaded AT-cut quartz resonator. J Appl Phys 68:1993-2001.
20. Johannsmann D, Mathauer K, Wegner G, Knoll W. 1992. Viscoelastic properties of thin films probed with a quartz-crystal resonator. Phys Rev B 46:7808-7815.
21. Bandey HL, Martin SJ, Cernosek RW, Hillman AR. 1999. Modeling the responses of thickness-shear mode resonators under various loading conditions. Anal Chem 71:2205-2214.
22. White CC, Schrag JL. 1999. Theoretical predictions for the mechanical response of a model quartz crystal microbalance to two viscoelastic media: A thin sample layer and surrounding bath medium. J Chem Phys 111:11192-11206.
23. Voinova MV, Rodahl M, Jonson M, Kasemo B. 1999. Viscoelastic acoustic response of layered polymer films at fluid-solid interfaces: Continuum mechanics approach. Phys Scr 59:391-396.
24. Johannsmann D. 2006. Modeling of QCM Data. Unpublished manuscript.
25. Herrscher M, Ziegler C, Johannsmann D. 2007. Shifts of frequency and bandwidth of quartz crystal resonators coated with samples of finite lateral size. J Appl Phys 101:114909-114912. (Pubitemid 46934973)
26. Fischer H, Polikarpov I, Craievich AF. 2004. Average protein density is a molecular-weight-dependent function. Protein Sci 13:2825-2828. (Pubitemid 39274651)
27. Prime KL, Whitesides GM. 1993. Adsorption of proteins onto surfaces containing end-attached oligo(ethylene oxide): A model system using self-assembled monolayers. J AmChem Soc 115: 10714-10721.
28. Nelson KE, Gamble L, Jung LS, Boeckl MS, Naeemi E, Golledge SL, Sasaki T, Castner DG, Campbell CT, Stayton PS. 2001. Surface characterization of mixed self-assembled monolayers designed for streptavidin immobilization. Langmuir 17:2549-2892. (Pubitemid 35330537)