Study on the effect of solution conditions on heat induced-aggregation of human alpha interferon

Iranian Journal of Pharmaceutical Research

Volumn 13, Issue SUPPL, 2014, Pages 27-34

  Salmannejad, Faranak ^a   Nafissi Varcheh, Nastaran ^a   Shafaati, Alireza ^a   Aboofazeli, Reza ^b  

^a SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES   (Iran)

^b SHAHID BEHESHTI UNIVERSITY OF MEDICAL SCIENCES   (Iran)

Author keywords

Interferon alpha2b; Optical density; SDS PAGE; SE HPLC; Thermal aggregation

Indexed keywords

ALPHA2B INTERFERON;

ARTICLE; DEGRADATION KINETICS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INCUBATION TEMPERATURE; LIGHT SCATTERING; OPTICAL DENSITY; PH; POLYACRYLAMIDE GEL ELECTROPHORESIS; PROTEIN AGGREGATION; PROTEIN STABILITY; SOLUTION AND SOLUBILITY; TEMPERATURE SENSITIVITY; TEMPERATURE STRESS; THERMAL AGGREGATION; TURBIDITY;

EID: 84894569252     PISSN: 17350328     EISSN: 17266890     Source Type: Journal    
DOI: None     Document Type: Article

References (33)

1. Aggarwal S. What's fueling the biotech engine-2007. Nat. Biotechnol. (2008) 26: 1227-1233.
2. Wang W, Singh S, Zeng DL, King K and Nema S. Antibody structure, instability and formulation. J. Pharm. Sci. (2007) 96: 1-26.
3. Gokarn YR, Kras E, Nodgaard C, Dharmavaram V, Fesinmeyer RM, Hultgen H, Brych S, Remmele RL, Jr Brems DN and Hershenson S. Self-buffering antibody formulations. J. Pharm. Sci. (2008) 97: 3051-366.
4. Carpenter JF, Cherney B and Rosenberg AS. The critical need for robust assays for quantitation and characterization of aggregates of therapeutic proteins. In: Mahler HC and Jiskoot W. (Eds.) Analysis of aggregates and particles in protein pharmaceuticals. New Jersey. John Wiley and Sons (2012) 1-7.
5. Nafissi-Varcheh N and Aboofazeli R. An approach to the design of a particulate system for oral protein delivery. II. Preparation and stability study of rhGH-loaded in simulated gastrointestinal fluids. Iran. J. Pharm. Res. (2011) 10: 183-192.
6. Sharma VK and Kalonia DS. Temperature-and pH-induced multiple partially unfolded states of recombinant human interferon-alpha2a: Possible implications in protein stability. Pharm. Res. (2003) 20: 1721-1729.
7. Ablinger E, Hellweger M, Leitgeb S and Zimmer A. Evaluating the effects of buffer conditions and extremolytes on thermostability of granulocyte colony-stimulating factor using high-throughput screening combined with design of experiments. Int. J. Pharm. (2012) 436: 744-752.
8. Eppler A, Weigandt M, Hanefeld A and Bunjes H. Relevant shaking stress conditions for antibody preformulation development. Eur. J. Pharm. Biopharm. (2010) 74: 139-147.
9. Nafissi-Varcheh N, Luginbuehl V, Aboofazeli R and Merkle HP. Preparing poly (lactide-co-glycolic acid) (PLGA) microspheres containing lysozyme-zinc precipitate using a modified double emulsion method. Iran. J. Pharm. Res. (2011) 10: 203-209.
10. Beldarrain A, Cruz Y, Cruz O, Navarro M and Gil M. Purification and conformational properties of a human interferon alpha2b produced in Escherichia coli. Biotechnol. Appl. Biochem. (2001) 33: 173-182.
11. Gitlin G, Tsarbopoulos A, Patel ST, Sydor W, Pramanik BN, Jacobs S, Westreich L, Mittelman S and Bausch JN. Isolation and characterization of a monomethioninesulfoxide variant of interferon alpha-2b. Pharm. Res. (1996) 13: 762-769.
12. Bordens R, Grossberg SE, Trotta PP and Nagabhushan TL. Molecular and biologic characterization of recombinant interferon-alpha2b. Semin. Oncol. (1997) 24: 41-51.
13. Yuen P and Kline D. Stable aqueous alpha interferon solution formulations. US Patent 5 766 582 (1998).
14. Isaacs A and Lindenmann J. Virus interference. I. The interferon. Proc. R. Soc. Lond. B. Biol. Sci. (1957) 147: 258-267.
15. Streuli M, Nagata S and Weissmann C. At least three human type alpha interferons: Structure of alpha 2. Science. (1980) 209: 1343-1347.
16. Ruiz L, Reyes N, Duany L, Franco A, Aroche K and Hardy Rando E. Long-term stabilization of recombinant human interferon alpha 2b in aqueous solution without serum albumin. Int. J. Pharm. (2003) 264: 57-72.
17. Braun A, Kwee L, Labow MA and Alsenz J. Protein aggregates seem to play a key role among the parameters influencing the antigenicity of interferon alpha (IFN-alpha) in normal and transgenic mice. Pharm. Res. (1997) 14: 1472-1478.
18. Hermeling S, Aranha L, Damen JM, Slijper M, Schellekens H, Crommelin DJ and Jiskoot W. Structural characterization and immunogenicity in wild-type and immune tolerant mice of degraded recombinant human interferon alpha2b. Pharm. Res. (2005) 22: 1997-2006.
19. Kueltzo LA and Midddaugh CR. Ultraviolet absorption spectroscopy. In: Jiskoot W and Crommelin DJA, (eds.) Methods for structural analysis of protein pharmaceuticals. Biotechnology: Pharmaceutical aspects. AAPS. Press (2005) 1-25.
20. Esfandiary R and Middaugh CR. ultraviolet absorption spectroscopy. In: Mahler HC and jiskoot W (eds.). Analysis of aggregation and particles in protein pharamaceuticals. New Jersey. John Wiley & Sons (2012) 171-200.
21. Qian J, Tang Q, Cronin B, Markovich R and Rustum A. Development of a high performance size exclusion chromatography method to determine the stability of human serum albumin in a lyophilized formulation of interferon alfa-2b. J. Chromatogr. A. (2008) 1194: 48-56.
22. Sluzky V, Shahrokh Z, Stratton P, Eberlein G and Wang YJ. Chromatographic methods for quantitative analysis of native, denatured, and aggregated basic fibroblast growth factor in solution formulations. Pharm. Res. (1994) 11: 485-490.
23. Chiti F, Stefani M, Taddei N, Ramponi G and Dobson CM. Rationalization of the effects of mutations on peptide and protein aggregation rates. Nature. (2003) 424: 805-808.
24. DuBay KF, Pawar AP, Chiti F, Zurdo J, Dobson CM and Vendruscolo M. Prediction of the absolute aggregation rates of amyloidogenic polypeptide chains. J. Mol. Biol. (2004) 341: 1317-1326.
25. Militello V, Casarino C, Emanuele A, Giostra A, Pullara F and Leone M. Aggregation kinetics of bovine serum albumin studied by FTIR spectroscopy and light scattering. Biophys. Chem. (2004) 107: 175-187.
26. Giger K, Vanam RP, Seyrek E and Dubin PL. Suppression of insulin aggregation by heparin. Biomacromol. (2008) 9: 2338-2344.
27. Majhi PR, Ganta RR, Vanam RP, Seyrek E, Giger K and Dubin PL. Electrostatically driven protein aggregation: beta-lactoglobulin at low ionic strength. Langmuir. (2006) 22: 9150-9159.
28. Chi EY, Krishnan S, Kendrick BS, Chang BS, Carpenter JF and Randolph TW. Roles of conformational stability and colloidal stability in the aggregation of recombinant human granulocyte colony-stimulating factor. Protein. Sci. (2003) 12: 903-913.
29. Eberlein GA, Stratton PR and Wang YJ. Stability of rhbFGF as determined by UV spectroscopic measurements of turbidity. PDA. J. Pharm. Sci. Technol. (1994) 48: 224-230.
30. Paborji M, Pochopin NL, Coppola WP and Bogardus JB. Chemical and physical stability of chimeric L6, a mouse-human monoclonal antibody. Pharm. Res. (1994) 11: 764-771.
31. Pikal MJ, Dellerman KM, Roy ML and Riggin RM. The effects of formulation variables on the stability of freeze-dried human growth hormone. Pharm. Res. (1991) 8: 427-436.
32. Wang YJ, Shahrokh Z, Vemuri S, Eberlein G, Beylin I and Busch M. Characterization, stability, and formulations of basic fibroblast growth factor. Pharm. Biotechnol. (1996) 9: 141-180.
33. Raibekas AA, Bures EJ, Siska CC, Kohno T, Latypov RF and Kerwin BA. Anion binding and controlled aggregation of human interleukin-1 receptor antagonist. Biochem. (2005) 44: 9871-9879.