Disaggregation of high-molecular weight species during downstream processing to recover functional monomer

Biotechnology Progress

Volumn 26, Issue 3, 2010, Pages 717-726

  Xu, Xuankuo ^a   Didio, David M ^a,b   Leister, Kirk J ^a   Ghose, Sanchayita ^a  

^a BRISTOL MYERS SQUIBB COMPANY   (United States)

^b ALLERGAN INC   (United States)

Author keywords

Chaotrope; Diaggregation; Downstream processing; Monomer

Indexed keywords

AGGREGATED PROTEIN; ANALYTICAL RESULTS; BATCH STUDIES; BOUND PROTEINS; CHAOTROPE; CHAOTROPIC AGENTS; DISAGGREGATION; DOWNSTREAM-PROCESSING; FUNCTIONAL MONOMER; FUSION PROTEINS; HIGH MOLECULAR WEIGHT; MOLECULAR MECHANISM; PHARMACOKINETIC PROPERTIES; PROTEIN A CHROMATOGRAPHY; PROTEIN AGGREGATION; PROTEIN RECOVERY;

COLUMN CHROMATOGRAPHY; MOLECULAR WEIGHT; MONOMERS; RECOVERY;

PROTEINS;

GUANIDINE; HYBRID PROTEIN; IMMUNOGLOBULIN FC FRAGMENT; INORGANIC SALT; THIOCYANATE SODIUM; THIOCYANIC ACID DERIVATIVE; UREA;

AFFINITY CHROMATOGRAPHY; ANIMAL; ARTICLE; CHEMISTRY; CHO CELL; CRICETULUS; HAMSTER; ISOLATION AND PURIFICATION; KINETICS; METABOLISM; METHODOLOGY; MOLECULAR WEIGHT; PH; PROTEIN MULTIMERIZATION; CHO CELL LINE; PROCEDURES;

ANIMALS; CHO CELLS; CHROMATOGRAPHY, AFFINITY; CRICETINAE; CRICETULUS; GUANIDINE; HYDROGEN-ION CONCENTRATION; IMMUNOGLOBULIN FC FRAGMENTS; KINETICS; MOLECULAR WEIGHT; PROTEIN MULTIMERIZATION; RECOMBINANT FUSION PROTEINS; SALTS; THIOCYANATES; UREA;

EID: 77954694854     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.373     Document Type: Article

References (44)

1. Bondos SE, Bicknell A. Detection and prevention of protein aggregation before, during, and after purification. Anal Biochem. 2003;316:223-231.
2. Shukla AA, Gupta P, Han X. Protein aggregation kinetics during Protein A chromatography: case study for an Fc fusion protein. J Chromatogr A. 2007;1171:22-28.
3. Mirzaei H, Regnier F. Protein: protein aggregation induced by protein oxidation. J Chromatogr B. 2008;873:8-14.
4. Kohno T, Carmichael DF, Sommer A, Thompson RC. Refolding of recombinant proteins. Meth Enzymol. 1990;185:187-195.
5. Bermudez O, Forciniti D. Aggregation and denaturation of antibodoes: a capillary electrophoresis, dynamic light scattering, and aqueous two-phase partitioning study. J Chromatogr B. 2004;807:17-24.
6. Chen T. Formulation concerns of protein drugs. Drug Dev Ind Pharm. 1992;18:1311-1354.
7. Nicorescu I, Loisel C, Vial C, Riaublanc A, Djelveh G, Cuvelier G, Legrand J. Combined effect of dynamic heat treatment and ionic strength on denaturation and aggregation of whey proteins-part I. Food Res Int. 2008;41:707-713.
8. Graciá-Juliá A, René M, Cortés-Muñz M, Picart L, López-Pedemonte T, Chevalier D, Dumay E. Effect of dynamic high pressure on whey protein aggregation: a comparison with the effect of continuous short-time thermal treatments. Food Hydrocolloids. 2008;22:1014-1032.
9. Collins KD. Ions from the Hofmeister series and osmolytes: effects on proteins in solution and in the crystallization process. Methods. 2004;34:300-311.
10. Pace CN. Conformational stability of globular proteins. Trends Biochem Sci. 1990;15:14-17.
11. Dill KA. Dominant forces in protein folding. Biochemistry. 1990;29:7133.
12. Cellmer T, Douma R, Huebner A, Prausnitz JM, Blanch HW. Kinetic studies of protein L aggregation and disaggregation. Biophys Chem. 2007;125:350-359.
13. Seefeldt MB, Rosendahl MS, Cleland JL, Hesterberg LK. Application of high hydrostatic pressure to dissociate aggregates and refold protein. Curr Pharm Biotechnol. 2009;10:447-455.
14. Demeule B, Lawrence MJ, Drake AF, Gurny R, Arvinte T. Characterization of protein aggregation: the case of a therapeutic immunoglobulin. Biochim Biophys Acta. 2007;1774: 146-153.
15. Hermeling S, Crommelin DJ, Schellekens H, Jiskoot W. Structure-immunogenicity relationships of therapeutic proteins. Pharm Res. 2004;21:897-903.
16. Bucciantini M, Giannoni E, Chiti F, Baroni F, Formigli L, Zurdo J, Taddei N, Ramponi G, Dobson CM, Stefani M. Inherent toxicity of aggregates implies a common mechanism for protein misfolding diseases. Nature. 2002;416:507-511.
17. Rosenberg AS. Effects of protein aggregates: an immunologic perspective. AAPS J. 2006;8:E501-E507.
18. Jahn EM, Schneider CK. How to systematically evaluate immunogenicity of therapeutic proteins-regulatory considerations. New Biotechnol. 2009;25:280-286.
19. Philo JS, Arakawa T. Mechanisms of protein aggregation. Curr Pharm Biotechnol. 2009;10:348-351.
20. Famm K, Hansen L, Christ D, Winter G. Thermodynamically stable aggregation-resistant antibody domains through directed evolution. J Mol Biol. 2008;376:926-931.
21. Tsumoto K, Ejima D, Kumagai I, Arakawa T. Practical considerations in refolding proteins from inclusiion bodies. Protein Expr Purif. 2003;28:1-8.
22. Chung K, Kim J, Cho B-K, Ko B-J, Hwang B-Y, Kim B-G. How does dextran sulfate prevent heat induced aggregation of protein? The mechanism and its limitation as aggregation inhibitor. Biochim Biophys Acta. 2007;1774:249-257.
23. Arakawa T, Tsumoto K. The effects of arginine on refolding of aggregated proteins: not facilitate refolding, but suppress aggregation. Biochem Biophys Res Commun. 2003;304:148-152.
24. Clinkenbeard KD, Clinkenbeard PA, Waurzynial BJ. Chaotropic agents cause disaggregation and enhanced activity of Pasteurella haemolytica leukotoxin. Vet Microbiol. 1995;45:201-209.
25. Jaenicke R. Stability and folding of domain proteins. Prog Biophys Mol Biol. 1999;71:155-241.
26. Utsumi J, Yamazaki S, Kawaguchi K, Kimura S, Shimizu H. Stability of human interferon-ß1: oligomeric human interferonß1 is inactive but is reactivated by monomerization. Biochim Biophys Acta. 1989;998:167-172.
27. Seefeldt MB, Ouyang J, Froland WA, Carpenter JF, Randolph TW. High-pressure refolding of bikunin: efficacy and thermodynamics. Protein Sci. 2004;13:2639-2650.
28. St. John RJ, Carpenter JF, Balny C, Randolph TW. High pressure refolding of recombinant human growth hormone from insoluble aggregates. J Biol Chem. 2001;276:46856-46863.
29. Kendrick BS, Carpenter JF, Cleland JL, Randolph TW. A transient expansion of the native state precedes aggregation of recombinant human interferon-γ. Proc Natl Acad Sci USA. 1998;95:14142-14146.
30. Roberts CJ. Kinetics of irreversible protein aggregation: analysis of extended Lumry-Eyring models and implications for predicting protein shelf life. J Phys Chem B. 2003;107:1197-1207.
31. Cao X, Li J, Yang X, Duan Y, Liu Y, Wang C. Nonisothermal kinetic analysis of the effect of protein concentration on BSA aggregation at high concentration by DSC. Thermochim Acta. 2008;467:99-106.
32. Ferrone F. Analysis of protein aggregation kinetics. Meth Enzymol. 1999;309:256-274.
33. Chen SM, Ferrone F, Wetzel R. Huntington's disease age-ofonset linked to polyglutamine aggregation nucleation. Proc Natl Acad Sci USA. 2002;99:11884-11889.
34. Roberts CJ. Non-native protein aggregation kinetices. Biotechnol Bioeng. 2007;98:927-938.
35. Lumry R, Eyring H. Conformation changes of proteins. J Phys Chem. 1954;58:110-120.
36. Kendrick BS, Cleland JL, Lam X, Nguren T, Randolph TW, Manning MC, Carpenter JF. Aggregation of recombinant human interferon gamma: kinetics and structural transitions. J Pharm Sci. 1998;87:1069-1076.
37. Smith JS, Scholtz JM. Guanidine hydrochloride unfolding of peptide helices: separation of denaturant and salt effects. Biochemistry. 1996;35:7292-7297.
38. Dempsey CE, Piggot TJ, Mason PE. Dissecting contributions to the denaturant sensitivites of proteins. Biochemistry. 2005;44: 775-781.
39. Attanasio R, Stunz GW, Kennedy RC. Folding patterns of immunoglobulin molecules identified by urea gradient electrophoresis. J Biol Chem. 1994;269:1834-1838.
40. Yang T, Malmquist G, Johansson B-L, Maloisel J-L, Cramer S. Evaluation of multi-modal high salt binding ion exchange materials. J Chromatogr A. 2007;1157:171-177.
41. Narhi LO, Caughey DJ, Horan T, Kita Y, Chang D, Arakawa T. Effect of three elution buffers on the recovery and structure of monoclonal antibodies. Anal Biochem. 1997;253:236-245.
42. Narhi LO, Caughey DJ, Horan T, Kita Y, Chang D, Arakawa T. Fractionation and characterization of polyclonal antibodies using three progressively more chaotropic solvents. Anal Biochem. 1997;253:246-252.
43. Snyder LR, Kirkland JJ. Introduction to Modern Liquid Chromatography. New York: Wiley; 1979.
44. Carta G, Ubiera A, Pabst T. Protein mass transfer kinetics in ion exchange media: measurements and interpretations. Chem Eng Technol. 2005;28:1252.