Aggregation of recombinant human botulinum protein antigen serotype c in varying solution conditions: Implications of conformational stability for aggregation kinetics

Journal of Pharmaceutical Sciences

Volumn 100, Issue 3, 2011, Pages 836-848

  Bai, Shujun ^a,d   Manning, Mark Cornell ^b   Randolph, Theodore W ^c   Carpenter, John F ^a  

^a UNIVERSITY OF COLORADO   (United States)

^b Legacy BioDesign LLC   (United States)

^c UCB 450   (United States)

^d BIOGEN   (United States)

Author keywords

Biophysical models; Circular dichroism; Fluorescence spectroscopy; Formulation; Protein aggregation; Protein folding refolding; Protein formulation; Protein structure; Solution calorimetry; Thermodynamics

Indexed keywords

BOTULINUM TOXIN; RECOMBINANT HUMAN BOTULINUM PROTEIN ANTIGEN SEROTYPE C; SODIUM CHLORIDE; TREHALOSE; UNCLASSIFIED DRUG; UREA;

ARTICLE; CIRCULAR DICHROISM; DIFFERENTIAL SCANNING CALORIMETRY; ENERGY; FLUORESCENCE; HEATING; KINETICS; PH; PROTEIN AGGREGATION; PROTEIN CONFORMATION; ULTRAVIOLET SPECTROSCOPY;

EID: 79251541171     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.22345     Document Type: Article

References (37)

1. Stefani M, Dobson CM. 2003. Protein aggregation and aggregate toxicity: New insights into protein folding, misfolding diseases and biological evolution. J Mol Med 81:678-699.
2. Koo EH, Lansbury PT. 1999. Amyloid diseases: Abnormal protein aggregation in neurodegeneration. Proc Natl Acad Sci U S A 96:9989-9990.
3. Manning MC, Patel K, Borchardt RT. 1989. Stability of protein pharmaceuticals. Pharm Res 6:903-918.
4. Cromwell ME, Hilario E, Jacobonson F. 2006. Protein aggregation and bioprocessing. AAPS J 15:E572-E579.
5. Townsend MW, Peluca PP. 1990. Stability of ribonuclease A in solution and the freeze-dried state. J Pharm Sci 79:1083-1086.
6. Runkel L, Meier W, Pepinsky RB. 1998. Structural and functional differences between glycosylated and non-glycosylated forms of human interferon-β (IFN-β). Pharm Res 15:641-649.
7. Yon JM. 1996. The specificity of protein aggregation. Nat Biotechnol 14:1231-1239.
8. Schellekens H. 2002. Bioequivalence and the immunogenicity of biopharmaceutical. Nat Res Drug Discov 1:457-462.
9. Rosenberg AS. 2006. Effects of protein aggregates: An immunological perspective. AAPS J 8:E501-E507.
10. Lumry R, Eyring H. 1954. Conformational changes in proteins. J Phys Chem 58:110-120.
11. 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.
12. Brange J, Andersen L. 1997. Toward understanding insulin fibrillation. J Pharm Sci 86:517-525.
13. Booth DR, Sunder M. 1997. Instability, unfolding and aggregation of human lysozyme variants underlying amyloid fibrillogenesis. Nature 385:787-793.
14. Bam NB, Cleland JL. 1996. Molten globule intermediate of recombinant human growth hormone: Stabilization with surfactants. Biotechnol Prog 12:801-809.
15. Webb JN, Webb SD, Cleland JL, Carpenter JF, Randolph TW. 2001. Partial molar volume, surface area, and hydration changes for equilibrium unfolding and formation of aggregation transition state: high-pressure and cosolute studies on recombinant human IFN-gamma. Proc Natl Acad Sci U S A 98:7259-7264.
16. Kendrick BS, Cleland JL, Lam X, Nguyen T, Randolph TW, Manning MC, Carpenter JF. 1998. Aggregation of recombinant human interferon gamma: Kinetics and structural transitions. J Pharm Sci 87:1069-1076.
17. Krishnan S, Chi EY, Webb JN, Chang BS, Shan D, Goldenberg M, Manning MC, Randolph TW, Carpenter JF. 2002. Aggregation of granulocyte colony stimulating factor under physiological conditions: characterization and thermodynamic inhibition. Biochemistry 41:6422-6431.
18. Chi EY, Krishnan S, Kendrick BS, Chang BS, Carpenter JF, Randolph TW. 2003. Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor. Protein Sci 12:903-913.
19. Brandau DT, Jones LS, Wiethoff CM, Rexroad J, Middaugh CR. 2003. Thermal stability of vaccines. J Pharm Sci 92:218-231.
20. Gill DM. 1982. Bacterial toxins: A table of lethal amounts. Microbiol Rev 46:86-94.
21. Lamanna C. 1959. The most poisonous poison. Science 130:763-772.
22. Comella C, Pullman S. 2004. Botulinum toxins in neurological disease. Muscle Nerve 29:628-644.
23. Smith LA, Jensen MJ, Montgomery VA, Brown DR, Ahmed SA, Smith TJ. 2004. Roads from vaccines to therapies. Mov Disord 19:S48-S52.
24. Kueltzo LA, Ersoy B, Ralston JP, Middaugh CR. 2003. Derivative absorbance spectroscopy and protein phase diagrams as tools for comprehensive protein characterization: A bGCSF case study. J Pharm Sci 92:1805-20.
25. Johnson M, Frasier S. 1985. Nonlinear least-squares analysis. Methods Enzymol 117:301-342.
26. Sanchez-Ruiz JM, Lopez-lacomba JL, Cortijo M, Mateo PL. 1988. Differential scanning calorimetry of the irreversible thermal denaturation of thermolysin. Biochemistry 27:1648-1652.
27. Lepock JR, Ritchie KP, Kolios MC, Rodahl AM, Heinz KA, Kruuv J. 1992. Influence of transition rates and scan rate on kinetic simulations of differential scanning calorimetry profiles of reversible and irreversible protein denaturation. Biochemistry 31:12706-12712.
28. Sanchez-Ruiz JM. 1992. Theoretical analysis of Lumry-Eyring models in differential scanning calorimetry. Biophys J 61:921-935.
29. Wu J, Yang JT, Wu CS. 1992. Beta-II conformation of all-beta proteins can be distinguished from unordered form by circular dichroism. Anal Biochem 200:359-364.
30. Manning MC, Woody RW. 1989. Theoretical study of the contribution of aromatic side chains to the circular dichroism of basic bovine pancreatic trypsin inhibitor. Biochemistry 28:8609-8613.
31. Pace CN, Laurents DV, Thomson JA. 1990. pH dependence of the urea and guanidine hydrochloride denaturation of ribonuclease A and ribonuclease T1. Biochemistry 29:2564-2572.
32. Pace CN, Laurents DV, Erickson RE. 1992. Urea denaturation of barnase: pH dependence and characterization of the unfolded state. Biochemistry 31:2728-2734.
33. Pace CN, Shirley BA, McNutt M, Gajiwala K. 1996. Forces contributing to the conformational stability of proteins. FASEB J 10:75-83.
34. Pace CN, Alston RW, Shaw KL. 2000. Charge-charge interactions influence the denatured state ensemble and contribute to protein stability. Protein Sci 9:1395-1398.
35. Luisi LL, Raleigh DP. 2000. pH-dependent interactions and the stability and folding kinetics of the N-terminal domain of L9. Electrostatic interactions are only weakly formed in the transition state of folding. J Mol Biol 299:1091-1100.
36. Myers JK, Pace CN, Scholtzd JM. 1995. Denaturant m values and heat capacity changes: Relation to changes in accessible surface areas of protein unfolding. Protein Sci 4:2138-2148.
37. Roy S, Henderson I, Nayar R, Randolph TW, Carpenter JF. 2008. Effect of pH on stability of recombinant botulinum serotype A vaccine in aqueous solution and during storage of freeze-dried formulations. J Pharm Sci 97:5132-5146.