Multivariate calibration of covalent aggregate fraction to the Raman spectrum of regular human insulin

Journal of Pharmaceutical Sciences

Volumn 97, Issue 9, 2008, Pages 3727-3734

  Gryniewicz, Connie M ^a   Kauffman, John F ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Multivariate analysis; Protein aggregation; Proteins; Raman spectroscopy; Spectroscopy

Indexed keywords

HUMAN INSULIN; INSULIN;

AGITATION; ARTICLE; GEL PERMEATION CHROMATOGRAPHY; METHODOLOGY; RAMAN SPECTROMETRY; TEMPERATURE;

EID: 53549121957     PISSN: 00223549     EISSN: 15206017     Source Type: Journal    
DOI: 10.1002/jps.21326     Document Type: Article

References (23)

1. Wang W. 1995. Instability, stabilization, and formulation of liquid protein pharmaceuticals. Int J Pharm 185:129-188.
2. Nguyen LT, Wiencek JM, Kirsch LE. 2003. Characterization methods for the physical stability of biopharmaceuticals. PDA J Pharm Sci Technol 57:429-445.
3. Brange J, Langkjaer L. 1995. Insulin structure and stability. Pharm Biotechnol 5:315-350.
4. Garriques LN, Frokjaer S, Carpenter JF, Brange J. 2002. The effect of mutations on the structure of insulin fibrils studied by fourier transform infrared (FTIR) spectroscopy and electron microscopy. J Pharm Sci 91:2473-2480.
5. 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.
6. Carpenter JF, Kendrick BS, Chang BS, Manning MC, Randolph TW. 1999. Inhibition of stress-induced aggregation of proteins. Methods Enzymol 309:236-255.
7. Cleland JL, Powell MF, Shire SJ. 1993. The development of stable protein formulations: A closer look at protein aggregation, deamidation, and oxidation. Crit Rev Ther Drug Carrier Syst 10:307-377.
8. Sluzky V, Klibanov AM, Langer R. 1992. Mechanism of isulin aggregation and stabilization in agitated aqueous solutions. Biotechnol Bioeng 40:895-903.
9. Brange J, Langkjaer L, Havelund S, Volund A. 1992. Chemical stability of insulin: 1. Hydrolytic degradation during storage of pharmaceutical preparations. Pharm Res 9:715-726.
10. Brange J, Havelund S, Hougaard P. 1992. Chemical stability of insulin: 2. Formation of higher molecular weight transformation products during storage of pharmaceutical insulin Preparations. Pharm Res 9:727-734.
11. United States Pharmacopeia and National Formulary (USP 29-NF 24). 2006. Rockville, MD: United States Pharmacopeia Convention. p 1136.
12. Novo Nordisk Pharmaceuticals. 1999. Novolin R package insert. Princeton, NJ: Novo Nordisk Pharmaceuticals.
13. Pelton JT, McLean LR. 2000. Spectroscopic methods for analysis of protein secondary structure. Anal Biochem 277:167-176.
14. Tatford OC, Gomme PT, Bertolini J. 2004. Analytical techniques for the evaluation of liquid protein therapuetics. Biotechnol Appl Biochem 40: 67-81.
15. Ye H. 2006. Simultaneous determination of protein aggregation, degradation, and absolute molecular weight by size exclusion chromatography-multiangle laser light scattering. Anal Biochem 356: 76-85.
16. Chi Z, Chen XG, Holtz JSW, Asher SA. 1998. UV resonance Raman selective amide vibrational enhancement: Quantitative methodology for determining protein secondary structure. Biochemistry 37:2854-2864.
17. Yu NY, Liu CS, O'Shea DC. 1972. Laser Raman spectroscopy and the conformation of insulin and proinsulin. J Mol Biol 70:117-132.
18. Ortiz C, Zhang D, Xie Y, Davisson VJ, Ben-Amotz D. 2004. Indentification of insulin variants using Raman spectroscopy. Anal Biochem 332:245-252.
19. Zhang D, Xie Y, Mrozek MF, Ortiz C, Davisson VJ, Ben-Amotz D. 2003. Raman detection of proteomic analytes. Anal Chem 75:5703-5709.
20. Ortiz C, Zhang D, Xie Y, Ribbe AE, Ben-Amotz D. 2006. Validation of the drop coating deposition Raman method for protein analysis. Anal Biochem 353:157-166.
21. Lougheed WD, Woulfe-Flanagan H, Clement JR, Albisser AM. 1980. Insulin aggregation in artificial delivery systems. Diabetologia 19:1-9.
22. Bohidar HB. 1989. Dynamic light scattering study of heat aggregation of insulin. Colloid Polym Sci 267:159-166.
23. Oliva A, Fariña JB, Llabrés M. 1996. Influence of temperature and shaking on stability of insulin preparations: Degradation kinetics. Int J Pharm 143:163-170.