Characterization of high-molecular-weight nonnative aggregates and aggregation kinetics by size exclusion chromatography with inline multi-angle laser light scattering

Journal of Pharmaceutical Sciences

Volumn 98, Issue 11, 2009, Pages 3997-4016

  Li, Yi ^a   Weiss IV, William F ^a   Roberts, Christopher J ^a  

^a Institute University of Delaware Newark   (United States)

Author keywords

Light scattering; Protein aggregation; Stability

Indexed keywords

CHYMOTRYPSINOGEN; SODIUM CHLORIDE;

ARTICLE; CIRCULAR DICHROISM; CONTROLLED STUDY; FLUORESCENCE SPECTROSCOPY; GEL PERMEATION CHROMATOGRAPHY; LIGHT SCATTERING; MOLECULAR WEIGHT; PROTEIN AGGREGATION; PROTEIN STABILITY; SIZE EXCLUSION CHROMATOGRAPHY WITH AN INLINE MULTI ANGLE LIGHT SCATTERING DETECTOR;

EID: 70349646469     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21726     Document Type: Article

References (56)

1. Dobson CM. 2004. Principles of protein folding, misfolding and aggregation. Semin Cell Dev Biol 15:3-16. (Pubitemid 38177363)
2. Roberts CJ. 2007. Non-native protein aggregation kinetics. Biotechnol Bioeng 98:927-938.
3. Weiss WF, Young TM, Roberts CJ. 2008. Principles, approaches, and challenges for predicting protein aggregation rates and shelf life. J Pharm Sci EarlyView 10.1002/jps.21521.
4. Fink AL. 1998. Protein aggregation: Folding aggregates, inclusion bodies and amyloid. Fold Des 3:R9-R23.
5. Chi EY, Krishnan S, Randolph TW, Carpenter JF. 2003. Physical stability of proteins in aqueous solution: Mechanism and driving forces in nonnative protein aggregation. Pharm Res 20:1325-1336. (Pubitemid 37164039)
6. Cromwell MEM, Hilario E, Jacobson F. 2006. Protein aggregation and bioprocessing. AAPS J 8:E572-E579.
7. Roberts CJ. 2006. Non-native protein aggregation: Pathways, kinetics, and shelf-life prediction. In: Murphy RM, Tsai AM, editors. Misbehaving proteins: Protein misfolding, aggregation, and stability. New York: Springer. pp 17-46.
8. Kopito RR. 2000. Aggresomes, inclusion bodies and protein aggregation. Trends Cell Biol 10:524-530.
9. Manning MC, Patel K, Borchardt RT. 1989. Stability of protein pharmaceuticals. Pharm Res 6:903-918.
10. Middaugh CR, Edwards KL. 1998. Recent advances in our understanding of protein conformational stability from a pharmaceutical perspective. Expert Opin Invest Drugs 7:1493-1500.
11. Shire SJ, Shahrokh Z, Liu J. 2004. Challenges in the development of high protein concentration formulations. J Pharm Sci 93:1390-1402. (Pubitemid 38725014)
12. Wang W. 2005. Protein aggregation and its inhibition in biopharmaceutics. Int J Pharm 289:1-30. (Pubitemid 40093537)
13. Shahrokh Z, Stratton PR, Eberlein GA, Wang YJ. 1994. Approaches to analysis of aggregates and demonstrating mass balance in pharmaceutical protein (basic fibroblast growth factor) formulations. J Pharm Sci 83:1645-1650.
14. Tatford OC, Gomme PT, Bertolini J. 2004. Analytical techniques for the evaluation of liquid protein therapeutics. Biotechnol Appl Biochem 40:67-81. (Pubitemid 39070910)
15. Andrews JM, Weiss WF, Roberts CJ. 2008. Nucleation, growth, and activation energies for seeded and unseeded aggregation of alpha- chymotrypsinogen A. Biochemistry 47:2397-2403.
16. Roberts CJ, Darrington RT, Whitley MB. 2003. Irreversible aggregation of recombinant bovine Granulocyte-Colony Stimulating Factor (bG-CSF) and implications for predicting protein shelf life. J Pharm Sci 92:1095-1111.
17. Andrews JM, Roberts CJ. 2007. Non-native aggregation of alpha-chymotrypsinogen occurs through nucleation and growth with competing nucleus sizes and negative activation energies. Biochemistry 46:7558-7571.
18. Ferrone F. 1999. Analysis of protein aggregation kinetics. Methods Enzymol 309:256-274.
19. Lee CC, Nayak A, Sethuraman A, Belfort G, McRae GJ. 2007. A three-stage kinetic model of amyloid fibrillation. Biophys J 92:3448-3458. (Pubitemid 46698637)
20. Oosawa F, Asakura S. 1975. Thermodynamics of the polymerization of proteins. London: Academic Press.
21. Pallitto MM, Murphy RM. 2001. A mathematical model of the kinetics of beta-amyloid fibril growth from the denatured state. Biophys J 81:1805-1822.
22. Weiss WF, Hodgdon TK, Kaler EW, Lenhoff AM, Roberts CJ. 2007. Nonnative protein polymers: Structure, morphology, and relation to nucleation and growth. Biophys J 93:4392-4403.
23. Modler AJ, Gast K, Lutsch G, Damaschun G. 2003. Assembly of amyloid protofibrils via critical oligomers - A novel pathway of amyloid formation. J Mol Biol 325:135-148. (Pubitemid 36153003)
24. Speed MA, King J, Wang DIC. 1997. Polymerization mechanism of polypeptide chain aggregation. Biotechnol Bioeng 54:333-343. (Pubitemid 27197989)
25. Andrews JM, Roberts CJ. 2007. A Lumry-Eyring nucleated-polymerization model of protein aggregation kinetics I. Aggregation with pre-equilibrated unfolding. J Phys Chem B 111:7897-7913.
26. Shahi P, Sharma R, Sanger S, Kumar I, Jolly R. 2007. Formation of amyloid fibrils via longitudinal growth of oligomers. Biochemistry 46:7365-7373. (Pubitemid 46986363)
27. Tycko R. 2006. Molecular structure of amyloid fibrils: Insights from solid-state NMR. Q Rev Biophys 39:1-55. (Pubitemid 44566373)
28. Li Y, Roberts CJ. A Lumry-Eyring Nucleated-Polymerization (LENP)model of protein aggregation kinetics 2. Competing growth via condensation- and chain-polymerization. J Phys Chem B (submitted).
29. Liu J, Andya JD, Shire SJ. 2006. A critical review of analytical ultracentrifugation and field flow fractionation methods for measuring protein aggregation. AAPS J 8:E580-E589. (Pubitemid 44507669)
30. Gabrielson JP, Brader ML, Pekar AH, Mathis KB, Winter G, Carpenter JF, Randolph TW. 2007. Quantitation of aggregate levels in a recombinant humanized monoclonal antibody formulation by size-exclusion chromatography, asymmetrical flow field flow fractionation, and sedimentation velocity. J Pharm Sci 96:268-279. (Pubitemid 46363558)
31. Goetz H, Kuschel M, Wulff T, Sauber C, Miller C, Fisher S, Woodward C. 2004. Comparison of selected analytical techniques for protein sizing, quantitation and molecular weight determination. J Biochem Biophys Methods 60:281-293. (Pubitemid 39179383)
32. Philo JS. 2006. Is any measurement method optimal for all aggregate sizes and types? AAPS J 8:E564-E571.
33. Knobloch JE, Shaklee PN. 1997. Absolute molecular weight distribution of low-molecular-weight heparins by size-exclusion chromatography with multiangle laser light scattering detection. Anal Biochem 245:231-241.
34. Wyatt PJ. 1993. Light scattering and the absolute characterization of macromolecules. Anal Chim Acta 272:1.
35. Nguyen LT, Wiencek JM, Kirsch LE. 2003. Characterization methods for the physical stability of biopharmaceuticals. PDA J Pharm Sci Technol 57:429-445.
36. Oliva A, Llabres M, Farina JB. 2004. Applications of multi-angle laser light-scattering detection in the analysis of peptides and proteins. Curr Drug Discov Technol 1:229-242.
37. Millard MM. 1999. The hydrodynamic characterization of waxy maize amylopectin in 90% dimethyl sulfoxide/water by analytical ultracentrifugation, dynamic, and static light scattering. Carbohydr Polym 39:315.
38. Soltes L, Mendichi R, Lath D, Mach M, Bakos D. 2002. Molecular characteristics of some commercial high-molecular-weight hyaluronans. Biomed Chromatogr 16:459-462. (Pubitemid 35314923)
39. Wei Z, McEvoy M, Razinkov V, Polozova A, Li E, Casas-Finet J, Tous GI, Balu P, Pan AA, Mehta H, Schenerman MA. 2007. Biophysical characterization of influenza virus subpopulations using field flow fractionation and multiangle light scattering: Correlation of particle counts, size distribution and infectivity. J Virol Methods 144:122-132. (Pubitemid 47095043)
40. Sletmoen M, Stokke BT. 2005. Structural properties of poly C-scleroglucan complexes. Biopolymers 79:115-127. (Pubitemid 41652908)
41. Roberts CJ. 2003. Kinetics of irreversible protein aggregation: Analysis of extended Lumry-Eyring models and implications for predicting protein shelf life. J Phys Chem B 107:1194-1207.
42. Wilcox PE. 1970. Chymotrypsinogens-chymotrypsins. Methods Enzymol 19:64.
43. Smith MH. 1970. Peptides and proteins. In: Sober HA, editor. Handbook of Biochemistry, Sect C, 2nd edition. Cleveland, OH: The Chemical Rubber Co. pp 71-98.
44. Zimm BH. 1948. The scattering of light and the radial distribution function of high-polymer solutions. J Chem Phys 16:1093-1099.
45. Berry GC. 1966. Thermodynamic and conformational properties of polystyrene. I. Light-scattering studies on dilute solutions of linear polystyrenes. J Chem Phys 44:4550-4564.
46. Frisken BJ. 2001. Revisiting the method of cumulants for the analysis of dynamic light-scattering data. Appl Opt 40:4087.
47. Koppel DE. 1972. Analysis of macromolecular polydispersity in intensity correlation spectroscopy: The method of cumulants. J Chem Phys 57:4814.
48. Selser JC. 1979. A determination of polymer number-averaged andweight-averagedmolecularweight using photon correlation spectroscopy. Macromolecules 12:909.
49. Bartkowski RE, Kitchel R, Peckham NR, Margulis L. 2002. Aggregation of recombinant bovine granulocyte colony stimulating factor in solution. J Protein Chem 21:137-1143. (Pubitemid 34462767)
50. LeVine H III. 1993. Thioflavine T interaction with synthetic Alzheimer's disease beta-amyloid peptides: Detection of amyloid aggregation in solution. Protein Sci 2:404-410.
51. Frieden C. 2007. Protein aggregation processes: In search of the mechanism. Protein Sci 16:2334-2344.
52. Gregersen N, Bolund L, Bross P. 2003. Protein misfolding, aggregation, and degradation in disease. Methods Mol Biol 232:3-16.
53. Chu B, Liu J. 2000. Characterization of nanoparticles by scattering techniques. J Nanoparticle Res 2:29-41.
54. Harding SE. 1995. On the hydrodynamic analysis of macromolecular conformation. Biophys Chem 55:69-93.
55. Cleland JL, Wang DIC. 1990. Refolding and aggregation of bovine carbonic anhydrase-B - Quasielastic light-scattering analysis. Biochemistry 29:11072-11078.
56. Harper JD, Lansbury PT. 1997. Models of amyloid seeding in Alzheimier's disease and scrapie: Mechanistic truths and physiological consequences of the time-dependent solubility of amyloid proteins. Annu Rev Biochem 66:385-407.