Effects of additives on heat denaturation of rhDNase in solutions

Pharmaceutical Research

Volumn 13, Issue 5, 1996, Pages 756-761

  Chan, Hak Kim ^a,b   Au Yeung, Kwok Leung ^a,c   Gonda, Igor ^a,d  

^a GENENTECH INC   (United States)

^b UNIVERSITY OF SYDNEY   (Australia)

^c University of California   (United States)

^d ARADIGM CORPORATION   (United States)

Author keywords

Additives; Calorimetry; Heat denaturation; Protein; rhDNase

Indexed keywords

CALCIUM CHLORIDE; DISACCHARIDE; DIVALENT CATION; DORNASE ALFA; DRUG ADDITIVE; GUANIDINE; HYDROCHLORIC ACID; LACTOSE; MAGNESIUM CHLORIDE; MANGANESE CHLORIDE; MANNITOL; SODIUM CHLORIDE; SODIUM HYDROXIDE; SUCROSE; SUGAR; TREHALOSE; UREA;

ARTICLE; DIFFERENTIAL SCANNING CALORIMETRY; ENTHALPY; GEL PERMEATION CHROMATOGRAPHY; PH; PRIORITY JOURNAL; PROTEIN DENATURATION; THERMOSTABILITY;

CALCIUM CHLORIDE; CALORIMETRY, DIFFERENTIAL SCANNING; CATIONS; CHROMATOGRAPHY, GEL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DEOXYRIBONUCLEASE I; HEAT; HUMANS; HYDROGEN-ION CONCENTRATION; PROTEIN DENATURATION; RECOMBINANT PROTEINS; SOLUTIONS;

EID: 0029889389     PISSN: 07248741     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1016007818575     Document Type: Article

References (21)

1. Privalov P L and Potekhin S A, Scanning microcalorimetry in studying temperature-induced changes in proteins. Methods Enzymol. 131:4-51 (1986).
2. A. M. Boctor and S. C. Mehta. Enhancement of the stability of thrombin by polyols: microcalorimetric studies. J Pharm. Pharmacol. 44:600-603 (1992).
3. S. Shak, D. J. Capon, R. Hellmiss, S. A. Marsters, C. L. Baker. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum, Proc. Natl. Acad. Sci. USA 87:9188-92 (1990).
4. H. J. Fuchs, D. S. Borowitz, D. H. Christiansen, E. M. Morris, M. L. Nash, B. W. Ramsey, B. J. Rosenstein, A. L. Smith and M. L. Wohl. Effect of aerosolized recombinant human DNase on exacerbations of respiratory symptoms and on pulmonary function in patients with cystic fibrosis, New Engl. J. Med. 331:637-642 (1994).
5. D. C. Cipolla, I. Gonda, K. C. Meserve, S. Week and S. J. Shire. Formulation and aerosol delivery of recombinant deoxyribonucleic acid derived human deoxyribonuclease I, in ACS Symposium Series No. 567 Formulation and Delivery of Proteins and Peptides, J. L. Cleland and R. Langer (eds), Am. Chem. Soc., Washington DC, 1994, pp. 322-342.
6. D. Cipolla, A. R. Clark, H.-K. Chan, I. Gonda and S. J. Shire. Assessment of aerosol delivery systems for recombinant human deoxyribonuclease. S.T.P. Pharma. Sci. 4:50-62 (1994).
7. W. Pfeil. Unfolding of proteins. In H.-J. Hinz (ed.), Thermodynamic Data for Biochemistry and Biotechnology, Springer-Verlag, Berlin, 1986, pp. 366-370.
8. J. Cacia, C. P. Quan, M. Vasser, M. B. Sliwkowski and J. Frenz. Protein sorting by high-performance liquid chromatography. I. Biomimetic interaction chromatography of recombinant human deoxyribonuclease I on polyionic stationary phase. J. Chromatogr. 634:229-239 (1993).
9. J. F. Back, D. Oakenfull and M. B. Smith, Increased thermal stability of proteins in the presence of sugars and polyols Biochemistry 18:5191-5196 (1979).
10. K. Gekko, Calorimetric study on thermal denaturation of lysozyme in polyol-water mixtures, J. Bioichem. 91:1197-1204 (1982).
11. T. Arakawa and S. N. Timasheff. Stabilization of protein structure by sugars, Biochemists 21:6536-6544 (1982).
12. P. A. Price, W. H. Stein and S. Moore. Effect of divalent cations on the reduction and re-formation of the disulfide bonds of deoxyribonuclease, J. Biol. Chem. 244:929-932 (1969).
13. 2+ in the activity of bovine pancreatic deoxyribonuclease, J. Biol. Chem. 250:1981-1986 (1975).
14. S. J. Shire. Stability characterization and formulation development of recombinant human deoxyribonuclease I [Pulmozyme®, (Dornase Alpha)]. In R. Pearlman and J. Wang (eds.). Stability and Characterization of Protein Drugs: Case Studies II, Plenum Press, New York, to be published.
15. P. A. Price, S. Moore and W. H. Stein. Alkylation of a histidine residue at the active site of bovine pancreatic deoxyribonuclease. J. Biol. Chem. 244:924-928 (1969).
16. T. L. Poulos and P. A. Price. Some effects of calcium ions on the structure of bovine pancreatic deoxyribonuclease A. J. Biol. Chem. 247:2900-2904.
17. 2+ on pH-induced hydrodynamic changes of bovine pancreatic deoxyribonucleade A, J. Biol. Chem. 253:3191-3196 (1978).
18. D. Suck and C. Oefner. Structure of DNase I at 2.0 A resolution suggests a mechanism for binding to and cutting DNA. Nature 321:620-625 (1986).
19. J. D. Love and R. R. Hewitt. The relationship between human serum and human pancreatic DNase I. J. Biol. Chem. 254:12588-12594 (1979).
20. T. Arakawa and S. N. Timasheff. Preferential interactions of proteins with salts in concentrated solutions, Biochemistry 21:6545-6552 (1982).
21. S. N. Timasheff and T. Arakawa in Protein Structure A Practical Approach, Creighton T E (ed), IRL Press, Oxford, 1990, pp. 331-345.