Phase separation in solutions of monoclonal antibodies and the effect of human serum albumin

Proceedings of the National Academy of Sciences of the United States of America

Volumn 108, Issue 40, 2011, Pages 16606-16611

  Wang, Ying ^a   Lomakin, Aleksey ^a   Latypov, Ramil F ^b   Benedek, George B ^a,c  

^a MASSACHUSETTS INSTITUTE OF TECHNOLOGY   (United States)

^b AMGEN INC   (United States)

^c USA   (United States)

Author keywords

Biopharmaceuticals; Coexistence curve; Critical point; Cryoprecipitation; Immunoglobulin

Indexed keywords

HUMAN SERUM ALBUMIN; IMMUNOGLOBULIN G2; MONOCLONAL ANTIBODY; WATER;

ARTICLE; CRYOGLOBULINEMIA; LIGHT SCATTERING; LIQUID; PH; PHASE SEPARATION; POLYMERIZATION; PRIORITY JOURNAL; PROTEIN INTERACTION; THERMODYNAMICS;

ANTIBODIES, MONOCLONAL; BIOPHARMACEUTICS; CRYOGLOBULINEMIA; HUMANS; SERUM ALBUMIN; TEMPERATURE; THERMODYNAMICS;

EID: 80053630809     PISSN: 00278424     EISSN: 10916490     Source Type: Journal    
DOI: 10.1073/pnas.1112241108     Document Type: Article

References (28)

1. An Z (2009) Therapeutic monoclonal antibodies: from bench to clinic (John Wiley & Sons, Hoboken, NJ.).
2. Shire SJ, Shahrokh Z, Liu J (2009) Challenges in the development of high protein concentration formulations. Current trends in monoclonal antibody development and manufacturing, eds SJ Shire, W Gombotz, K Bechtold-Peters, and J Andya (Springer, New York), pp 131-147.
3. WangW, Roberts CJ (2010) Aggregation of therapeutic proteins (Wiley, Hoboken, NJ).
4. Rosenberg AS (2006) Effects of protein aggregates: an immunologic perspective. AAPS J 8:E501-507.
5. Chen S, Lau H, Brodsky Y, Kleemann GR, Latypov RF (2010) The use of native cationexchange chromatography to study aggregation and phase separation of monoclonal antibodies. Protein Sci 19:1191-1204.
6. Mason BD, Zhang-van Enk J, Zhang L, Remmele RL, Jr, Zhang J (2010) Liquid-liquid phase separation of a monoclonal antibody and nonmonotonic influence of Hofmeister anions. Biophys J 99:3792-3800.
7. Nishi H, et al. (2010) Phase separation of an IgG1 antibody solution under a low ionic strength condition. Pharm Res 27:1348-1360.
8. Lewus RA, Darcy PA, Lenhoff AM, Sandler SI (2011) Interactions and phase behavior of a monoclonal antibody. Biotechnol Progr 27:280-289.
9. Trilisky E, Gillespie R, Osslund TD, Vunnum S (2011) Crystallization and liquid-liquid phase separation of monoclonal antibodies and Fc-fusion proteins: screening results. Biotechnol Progr, 27 pp:1054-1067.
10. Charles ED, Dustin LB (2009) Hepatitis C virus-induced cryoglobulinemia. Kidney Int 76:818-824.
11. Fabris P, et al. (2003) Prevalence and clinical significance of circulating cryoglobulins in HIV-positive patients with and without Co-infection with hepatitis C virus. J Med Virol 69:339-343. (Pubitemid 36158313)
12. Dimopoulos MA, Alexanian R (1994) Waldenstroms macroglobulinemia. Blood 83:1452-1459.
13. Schurtenberger P, Chamberlin RA, Thurston GM, Thomson JA, Benedek GB (1989) Observation of critical phenomena in a protein-water solution. Phys Rev Lett 63:2064-2067.
14. Lomakin A, Asherie N, Benedek GB (1996) Monte Carlo study of phase separation in aqueous protein solutions. J Chem Phys 104:1646-1656. (Pubitemid 126747367)
15. Omenn GS (2006) Exploring the human plasma proteome (Wiley-VCH, Weinheim) p xxii, 372.
16. Wang Y, Lomakin A, McManus JJ, Ogun O, Benedek GB (2010) Phase behavior of mixtures of human lens proteins Gamma D and Beta B1. Proc Natl Acad Sci USA 107:13282-13287.
17. Lau H, et al. (2010) Investigation of degradation processes in IgG1 monoclonal antibodies by limited proteolysis coupled with weak cation-exchange HPLC. J Chromatogr B 878:868-876.
18. Broide ML, Berland CR, Pande J, Ogun OO, Benedek GB (1991) Binary-liquid phase separation of lens protein solutions. Proc Natl Acad Sci USA 88:5660-5664. (Pubitemid 21914805)
19. Liu C, et al. (1996) Phase separation in aqueous solutions of lens gamma-crystallins: special role of gamma s. Proc Natl Acad Sci USA 93:377-382.
20. Thomson JA, Schurtenberger P, Thurston GM, Benedek GB (1987) Binary liquid phase separation and critical phenomena in a protein/water solution. Proc Natl Acad Sci USA 84:7079-7083.
21. Delaye M, Clark JI, Benedek GB (1981) Coexistence curves for the phase separation in the calf lens cytoplasm. Biochem Biophys Res Commun 100:908-914.
22. Jion AI, Goh LT, Oh SK (2006) Crystallization of IgG1 by mapping its liquid-liquid phase separation curves. Biotechnol Bioeng 95:911-918. (Pubitemid 44863209)
23. Lomakin A, Asherie N, Benedek GB (1999) Aeolotopic interactions of globular proteins. Proc Nat'l Acad Sci USA 96:9465-9468. (Pubitemid 29398753)
24. Taratuta VG, Holschbach A, Thurston GM, Blankschtein D, Benedek GB (1990) Liquidliquid phase separation of aqueous lysozyme solutions-effects of pH and salt identity. J Phys Chem 94:2140-2144.
25. Sandin S, Ofverstedt LG, Wikstrom AC, Wrange O, Skoglund U (2004) Structure and flexibility of individual immunoglobulin G molecules in solution. Structure 12:409-415. (Pubitemid 38353062)
26. Harris LJ, Larson SB, Skaletsky E, McPherson A (1998) Comparison of the conformations of two intact monoclonal antibodies with hinges. Immunol Rev 163:35-43. (Pubitemid 28327860)
27. Landau LD, Lifshitz EM, Pitaevskii LP (1980) Statistical physics (Pergamon Press, Oxford; New York), 3d rev. and enl. Ed.
28. Silverton EW, Navia MA, Davies DR (1977) Three-dimensional structure of an intact human immunoglobulin. Proc Natl Acad Sci USA 74:5140-5144. (Pubitemid 8239062)