Effect of protamine on the solubility and deamidation of human growth hormone

International Journal of Pharmaceutics

Volumn 427, Issue 2, 2012, Pages 209-216

  Ablinger, Elisabeth ^a,b   Wegscheider, Stefan ^b   Keller, Walter ^b   Prassl, Ruth ^c   Zimmer, Andreas ^b  

^a RESEARCH CENTER PHARMACEUTICAL ENGINEERING GMBH   (Austria)

^b UNIVERSITY OF GRAZ   (Austria)

^c ERICH SCHMID INSTITUTE OF MATERIALS SCIENCE   (Austria)

Author keywords

Deamidation; Human growth hormone; pH; Protamine; Protein formulation; Protein solubility

Indexed keywords

DNA; HUMAN GROWTH HORMONE; PROTAMINE;

ARTICLE; CIRCULAR DICHROISM; DEAMINATION; ISOTHERMAL TITRATION CALORIMETRY; LIGHT SCATTERING; PH; PRIORITY JOURNAL; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SALMON; SOLUBILITY; SPERM; STATIC ELECTRICITY; SURFACE CHARGE; TURBIDITY; X RAY CRYSTALLOGRAPHY; ZETA POTENTIAL;

AMIDES; CALORIMETRY; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CIRCULAR DICHROISM; ELECTROCHEMISTRY; EXCIPIENTS; HUMAN GROWTH HORMONE; HUMANS; HYDROGEN-ION CONCENTRATION; ISOELECTRIC POINT; LIGHT; NEPHELOMETRY AND TURBIDIMETRY; PROTAMINES; SCATTERING, RADIATION; SCATTERING, SMALL ANGLE; SOLUBILITY; SPECTROPHOTOMETRY, ULTRAVIOLET; X-RAYS;

EID: 84859102682     PISSN: 03785173     EISSN: 18733476     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2012.01.061     Document Type: Article

References (37)

1. T. Ando, M. Yamasaki, and K. Suzuki Protamines: Isolation, Characterization, Structure and Function vol. 1 1973 Springer Verlag Berlin
2. V. Ball, and C. Maechling Isothermal microcalorimetry to investigate non specific interactions in biophysical chemistry Int. J. Mol. Sci. 10 2009 3283 3315
3. A.K. Banga Formulation of therapeutic peptides and proteins A.K. Banga, Therapeutic peptides and proteins Formulation, Processing and Delivery Systems 2009 Technomic Publishing Company Inc. Lancaster 81 129
4. B.M. Baynes, and B.L. Trout Rational design of solution additives for the prevention of protein aggregation Biophys. J. 87 2004 1631 1639
5. G.W. Becker, P.M. Tackitt, W.W. Bromer, D.S. Lefeber, and R.M. Riggin Isolation and characterization of a sulfoxide and a desamido derivative of biosynthetic human growth hormone Biotechnol. Appl. Biochem. 10 1988 326 337
6. T.A. Bewley, and C.H. Li Circular dichroism studies on human pituitary growth hormone and ovine pituitary lactogenic hormone Biochemistry 11 1972 884 888
7. W.R. Bowen, N.J. Hall, L. Pan, A.O. Sharif, and P.M. Williams The relevance of particle size and zeta-potential in protein processing Nat. Biotechnol. 16 1998 785 787
8. J. Brange, B. Skelbaek-Pedersen, L. Langkjaer, U. Damgaard, H. Ege, S. Hayelund, L.G. Heding, K.H. Jorgensen, J. Lykkeberg, J. Markussen, M. Pingel, and E. Rasmussen Galenics of Insulin - The Physico-Chemical and Pharmaceutical Aspects of Insulin and Insulin Preparations first ed. 1987 Springer Verlag Berlin
9. W.Q. Chen, A. Salmazo, M. Myllykoski, B. Sjoblom, M. Bidlingmaier, A. Pollak, P. Baumgaertel, K. Djionovic-Carugo, P. Kursula, and G. Lubec Purification of recombinant growth hormone by clear native gels for conformational analyses: preservation of conformation and receptor binding Amino Acids 39 2010 859 869
10. M. Cholewinski, B. Lückel, and H. Horn Degradation pathways, analytical characterization and formulation strategies of a peptide and a protein calcitonine and human growth hormone in comparison Pharm. Acta Helv. 71 1996 405 419
11. J.L. Cleland, M.F. Powell, and S.J. Shire The development of stable protein formulations: a close look at protein aggregation, deamidation, and oxidation Crit. Rev. Ther. Drug Carrier Syst. 10 1993 307 377
12. A.M. de Vos, M. Ultsch, and A.A. Kossiakoff Human growth hormone and extracellular domain of its receptor: crystal structure of the complex Science 255 1992 306 312
13. B.M. Eckhardt, J.Q. Oeswein, D.A. Yeung, T.D. Milby, and T.A. Bewley A turbidimetric method to determine visual appearance of protein solutions PDA J. Pharm. Sci. Technol. 48 1994 64 70
14. W. Friess, H.C. Mahler, and S. Jörg Highly concentrated protein formulations H.C. Mahler, G. Borchard, H.L. Luessen, Protein Pharmaceuticals - Formulation, Analytics and Delivery 2010 Editio Cantor Verlag Aulendorf 192 220
15. H. Hamada, T. Arakawa, and K. Shiraki Effect of additives on protein aggregation Curr. Pharm. Biotechnol. 10 2009 400 407
16. J.A. Hoffmann, R.E. Chance, and M.G. Johnson Purification and analysis of the major components of chum salmon protamine contained in insulin formulations using high-performance liquid chromatography Protein Expr. Purif. 1 1990 127 133
17. N. Jenkins, L. Murphy, and R. Tyther Post-translational modifications of recombinant proteins: significance for biopharmaceuticals Mol. Biotechnol. 39 2008 113 118
18. C. Kirchhoff Introduction to protein chemistry H.C. Mahler, G. Borchard, H.L. Luessen, Protein Pharmaceuticals - Formulation, Analytics and Delivery 2010 Editio Cantor Verlag Aulendorf 18 43
19. M. Kudou, K. Shiraki, S. Fujiwara, T. Imanaka, and M. Takagi Prevention of thermal inactivation and aggregation of lysozyme by polyamines Eur. J. Biochem. 270 2003 4547 4554
20. H.C. Mahler, W. Friess, U. Grauschopf, and S. Kiese Protein aggregation: pathways, induction factors and analysis J. Pharm. Sci. 98 2009 2909 2934
21. M.C. Manning, D.K. Chou, B.M. Murphy, R.W. Payne, and D.S. Katayama Stability of protein pharmaceuticals: an update Pharm. Res. 27 2010 544 575
22. M. Marian Growth hormones D.J.A. Crommelin, R.D. Sindelar, Pharmaceutical Biotechnology - An Introduction for Pharmacists and Pharmaceutical Scientists 2002 Taylor & Francis Abingdon 245 258
23. R.H. Müller, and R. Schuhmann Teilchengrößenmessung in der Laborpraxis first ed. 1996 Wissenschaftliche Verlagsgesellschaft mbh Stuttgart
24. E. Mylonas, and D.I. Svergun Accuracy of molecular mass determination of proteins in solution by small-angle X-ray scattering J. Appl. Crystallogr. 40 2007 S245 S249
25. K. Patel, and R.T. Borchardt Chemical pathways of peptide degradation. II. Kinetics of deamidation of an asparaginyl residue in a model hexapeptide Pharm. Res. 7 1990 703 711
26. R. Pearlman, and T.A. Bewley Stability and characterization of human growth hormone Y.J. Wang, R. Pearlman, Stability and Characterization of Protein and Peptide Drugs: Case Histories 1993 Plenum Press New York 1 58
27. Ph.Eur. 2.21, 2008. Clarity and Degree of Opalescense of Liquids, 6.2 edition. European Directorate for the Quality of Medicine, p. 23.
28. Ph.Eur. 6.0/0951, 2008. Somatropin, 6.2 edition. European Directorate for the Quality of Medicine, pp. 3937-3940.
29. R.M. Riggin, and N.A. Farid Analytical chemistry of therapeutic proteins C. Horvath, J.G. Nikelly, Analytical Biotechnology: Capillary Electrophoresis and Chromatography. 1990 American Chemical Society Washington DC 113 126
30. N.E. Robinson Structure-dependent nonenzymatic deamidation of glutaminyl and asparaginyl pentapeptides J. Peptide Res. 63 2004 426 436
31. C.P. Schneider, and B.L. Trout Investigation of cosolute-protein preferential interaction coefficients: new insight into the mechanism by which arginine inhibits aggregation J. Phys. Chem. B 113 2009 2050 2058
32. A. Schön, and A. Velazquez-Campoy Calorimetry W. Jiskoot, D.J.A. Crommelin, Methods for Structural Analysis of Protein Pharmaceuticals vol. 3 2005 AAPS Arlington, VA 573 589
33. D. Shukla, and B.L. Trout Interaction of arginine with proteins and the mechanism by which it inhibits aggregation J. Phys. Chem. B 114 2010 13426 13438
34. D.I. Svergun Determination of the regularization parameter in indirect-transform methods using perceptual criteria J. Appl. Crystallogr. 25 1992 495 503
35. D.I. Svergun, C. Barberato, and M.H.J. Koch CRYSOL - a program to evaluate X-ray solution scattering of biological macromolecules from atomic coordinates J. Appl. Crystallogr. 28 1995 768 773
36. L. Whitmore, and B.A. Wallace DICHROWEB, an online server for protein secondary structure analyses from circular dichroism spectroscopic data Nucleic Acids Res. 32 2004 W668 W673
37. K. Yasui, M. Uegaki, K. Shiraki, and T. Ishimizu Enhanced solubilization of membrane proteins by alkylamines and polyamines Protein Sci. 19 2010 486 493