Size-exclusion chromatography based on silica-diol for the analysis of the proinsulin fusion protein

Journal of Chromatography A

Volumn 1176, Issue 1-2, 2007, Pages 157-162

  Gusarova, V ^a   Vorobjeva, T ^a   Gusarov, D ^a   Lasman, V ^a   Bayramashvili, D ^a  

^a SHEMYAKIN OVCHINNIKOV INSTITUTE OF BIOORGANIC CHEMISTRY   (Russian Federation)

Author keywords

Proinsulin fusion protein; Qualification; Size exclusion chromatography; Validation

Indexed keywords

BIOASSAY; INSULIN; ION EXCHANGE; ROBUSTNESS (CONTROL SYSTEMS); SILICA; SIZE EXCLUSION CHROMATOGRAPHY;

ION EXCHANGE PURIFICATION; PROINSULIN FUSION PROTEINS; QUALIFICATION; VALIDATION;

PROTEINS;

HYBRID PROTEIN; PROINSULIN; SILICON DIOXIDE;

ACCURACY; ARTICLE; GEL PERMEATION CHROMATOGRAPHY; ION EXCHANGE CHROMATOGRAPHY; MOLECULAR WEIGHT; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; PROTEIN ANALYSIS; SENSITIVITY AND SPECIFICITY; VALIDATION STUDY;

CHROMATOGRAPHY, GEL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; ELECTROPHORESIS, POLYACRYLAMIDE GEL; PROINSULIN; RECOMBINANT FUSION PROTEINS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY;

EID: 36649007046     PISSN: 00219673     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.chroma.2007.10.090     Document Type: Article

References (18)

1. Nilsson J., Jonasson P., Samuelsson E., Stahl S., and Uhlen M. J. Biotechnol. 48 (1996) 241
2. Kroeff E.P., Owens R.A., Campbell E.L., Johnson R.D., and Marks H.I. J. Chromatogr. 2 (1989) 45
3. Castellanos-Serra L.R., Hardly E., Ubieta R., Vispo N.S., Fernandez C., Besada V., Falcon V., Gonsalez M., Silva A., and Herrera L. J. Am. Chem. Soc. 378 (1996) 171
4. Kjeldsen T. Appl. Microbiol. Technol. 54 (2000) 277
5. Gusarov D., Lasman V., and Bayramashvili D. J. Chromatogr. B 853 (2007) 354
6. Cowley D.J., and Mackin R.B. FEBS Lett. 402 (1997) 124-130
7. Petrides D., Sapidou E., and Calandranis J. Biotechnol. Bioeng. 48 (1995) 529
8. Bayramashvili D. Russ. Chem. J. 1 (2005) 34
9. Oliva A., Farina J., and Llabres N. J. Chromatogr. B 749 (2000) 25
10. Brange J., Havelund S., and Hougaard P. Pharm. Res. 9 (1992) 727
11. Klyushnichenko V., and Wulfson A. Russ. J. Bioorg. Chem. 2 (1993) 174
12. British Pharmacopoeia 1988, H.M. Stationary Office, London, 1988, p. 312.
13. The United States Pharmacopeia, Philadelphia, PA, USA, 2000 (USP24), Suppl. 3.
14. A WHO Guide To Good Manufacturing Practice (GMP) Requirements, Part 2: Validation, World Health Organization, Geneva, 1997, pp. 1-100.
15. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Validation of Analytical Procedures: Text and Methodology (Q2(R1)), Geneva, November 2005.
16. L.I. Patrushev, D.I. Bayramashvili, A.I. Miroshnikov, Russ. Fed. Pat. 2267534 (2006).
17. Laemmli U.K. Nature 227 (1970) 680
18. Guidance for industry: Bioanalytical method validation, US Department of Health and Human Services, Food and Drug Administration, Rockville, MD, May 2001.