Screening of monoclonal antibody formulations based on high-throughput thermostability and viscosity measurements: Design of experiment and statistical analysis

Journal of Pharmaceutical Sciences

Volumn 100, Issue 4, 2011, Pages 1330-1340

  He, Feng ^a   Woods, Christopher E ^a   Trilisky, Egor ^a   Bower, Keith M ^a   Litowski, Jennifer R ^a   Kerwin, Bruce A ^a   Becker, Gerald W ^a   Narhi, Linda O ^b   Razinkov, Vladimir I ^a  

^a AMGEN INC   (United States)

^b AMGEN INC   (United States)

Author keywords

Design of experiment; Excipients; High throughput; Monoclonal antibodies; Preformulation; Protein formulation; Thermal analysis; Viscosity

Indexed keywords

BUFFER; EXCIPIENT; IMMUNOGLOBULIN G2; MONOCLONAL ANTIBODY; IMMUNOGLOBULIN G;

ARTICLE; HIGH THROUGHPUT SCREENING; HYDROPHOBICITY; LIFE CYCLE; PH; PROTEIN STABILITY; SOLUTION AND SOLUBILITY; STATISTICAL ANALYSIS; TEMPERATURE; THERMOSTABILITY; VISCOSITY; CHEMISTRY; DRUG STABILITY; PROCEDURES;

ANTIBODIES, MONOCLONAL; BUFFERS; DRUG STABILITY; EXCIPIENTS; HIGH-THROUGHPUT SCREENING ASSAYS; IMMUNOGLOBULIN G; PROTEIN STABILITY; TEMPERATURE; VISCOSITY;

EID: 79951892441     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22384     Document Type: Article

References (23)

1. Shire SJ. 2009. Formulation and manufacturability of biologics. Curr Opin Biotechnol 20(6):708-714.
2. Bee JS, Chiu D, Sawicki S, Stevenson JL, Chatterjee K, Freund E, Carpenter JF, Randolph TW. 2009. Monoclonal antibody interactions with micro- and nanoparticles: Adsorption, aggregation, and accelerated stress studies. J Pharm Sci 98(9):3218-3238.
3. He F, Hogan S, Latypov RF, Narhi LO, Razinkov VI. 2010. High throughput thermostability screening of monoclonal antibody formulations. J Pharm Sci 99(4):1707-1720.
4. Ericsson UB, Hallberg BM, Detitta GT, Dekker N, Nordlund P. 2006. Thermofluor-based high-throughput stability optimization of proteins for structural studies. Anal Biochem 357(2):289-298.
5. Fesinmeyer RM, Hogan S, Saluja A, Brych SR, Kras E, Narhi LO, Brems DN, Gokarn YR. 2009. Effect of ions on agitation- and temperature-induced aggregation reactions of antibodies. Pharm Res 26(4):903-913.
6. Treuheit MJ, Kosky AA, Brems DN. 2002. Inverse relationship of protein concentration and aggregation. Pharm Res 19(4):511-516.
7. Liu J, Nguyen MD, Andya JD, Shire SJ. 2005. Reversible self-association increases the viscosity of a concentrated monoclonal antibody in aqueous solution. J Pharm Sci 94(9):1928-1940.
8. He F, Becker GW, Litowski JR, Narhi LO, Brems DN, Razinkov VI. 2010. High-throughput dynamic light scattering method for measuring viscosity of concentrated protein solutions. Anal Biochem 399(1):141-143.
9. Monkos K, Turczynski B. 1999. A comparative study on viscosity of human, bovine and pig IgG immunoglobulins in aqueous solutions. Int J Biol Macromol 26(2-3):155-159.
10. Patapoff TW, Esue O. 2009. Polysorbate 20 prevents the precipitation of a monoclonal antibody during shear. Pharm Dev Technol 14(6):659-664.
11. Yadav S, Liu J, Shire SJ, Kalonia DS. 2010. Specific interactions in high concentration antibody solutions resulting in high viscosity. J Pharm Sci 99(3):1152-1168.
12. Saluja A, Badkar AV, Zeng DL, Nema S, Kalonia DS. 2007. 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):234-244.
13. Saluja A, Kalonia DS. 2008. Nature and consequences of protein-protein interactions in high protein concentration solutions. Int J Pharm 358(1-2):1-15.
14. Saluja A, Badkar AV, Zeng DL, Nema S, Kalonia DS. 2006. 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 95(9):1967-1983.
15. 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(6):1161-1168.
16. Kanai S, Liu J, Patapoff TW, Shire SJ. 2008. Reversible self-association of a concentrated monoclonal antibody solution mediated by Fab-Fab interaction that impacts solution viscosity. J Pharm Sci 97(10):4219-4227.
17. Eguchi Y, Karino T. 2008. Measurement of rheologic property of blood by a falling-ball blood viscometer. Ann Biomed Eng 36(4):545-553.
18. Rosencranz R, Bogen SA. 2006. Clinical laboratory measurement of serum, plasma, and blood viscosity. Am J Clin Pathol 125(Suppl):S78-S86.
19. Shukla AA, Hubbard B, Tressel T, Guhan S, Low D 2007. Downstream processing of monoclonal antibodies- application of platform approaches. J Chromatogr B Analyt Technol Biomed Life Sci 848(1):28-39.
20. Niesen FH, Berglund H, Vedadi M 2007. The use of differential scanning fluorimetry to detect ligand interactions that promote protein stability. Nat Protoc 2(9):2212-2221.
21. Sall J, Creighton L, Lehman A. 2005 JMP start statistics: A guide to statistics and data analysis using JMP and JMP IN Software, 3th ed. Cary, North Carolina: SAS Institute Inc.
22. Ramani K, Purohit V, Middaugh CR, Balasubramanian SV. 2005. Aggregation kinetics of recombinant human FVIII (rFVIII). J Pharm Sci 94(9):2023-2029.
23. 2009. Guidance for industry, Q8(R2) pharmaceutical development. In US DHHS, FDA, CDER, CBER, Eds.