Facile purification of mono-PEGylated interleukin-1 receptor antagonist and its characterization with multi-angle laser light scattering

Process Biochemistry

Volumn 42, Issue 6, 2007, Pages 971-977

  Yu, Pengzhan ^a,b   Zhang, Guicai ^c   Bi, Jingxiu ^a   Lu, Xiuling ^a   Wang, Yunshan ^a   Su, Zhiguo ^a  

^a INSTITUTE OF PROCESS ENGINEERING   (China)

^b UNIVERSITY OF CHINESE ACADEMY OF SCIENCES   (China)

^c Beijing Baiao Pharmaceuticals Co Ltd   (China)

Author keywords

Bioactivity; Cytokine; Multi angle laser light scattering; PEGylation; Recombinant human interleukin 1 receptor antagonist

Indexed keywords

BIOACTIVITY; CHROMATOGRAPHIC ANALYSIS; CONJUGATED POLYMERS; ION EXCHANGE; LIGHT SCATTERING; POLYETHYLENE GLYCOLS; PURIFICATION;

CYTOKINE; MULTI-ANGLE LASER LIGHT SCATTERING; PEGYLATION; RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST;

POLYPEPTIDES;

EID: 34247893872     PISSN: 13595113     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.procbio.2007.03.003     Document Type: Article

References (35)

1. Kluczyk A., Cebrat M., Zbozień-Pacamaj R., Lisowski M., Stefanowicz P., Wieczorek Z., et al. On the peptide-antipiptide interactions in interleukin-1 receptor system. Acta Biochim Polonica 51 (2004) 57-66
2. Hannum C.H., Wilcox C.J., Arend W.P., Joslin F.G., Dripps D.J., Heimdal P.L., et al. Interleukin-1 receptor antagonist activity of a human interleukin-1 inhibitor. Nature 343 (1990) 336-340
3. Nicklin M.J., Hughes D.E., Barton J.L., Ure J.M., and Duff G.W. Arterial inflammation in mice lacking the interleukin 1 receptor antagonist gene. J Exp Med 191 (2000) 303-312
4. Schreuder H.A., JRondeau M., Tardif C., Soffientini A., Sarubbi E., Akeson A., et al. Refined crystal strcture of the interleukin-1 receptor antagonist presence of a disulfide link and a cis-proline. Eur J Biochem 227 (1995) 838-847
5. Eisenberg S.P., Evans R.J., Arend W.P., Verderber E., Brewer M.T., Hannum C.H., et al. Primary structure and functional expression from complementary DNA of a human interleukin-1 receptor antagonist. Nature 343 (1990) 341-346
6. Small R.E., Wixted M.A., and Roberts W.N. Anakinra An interleukin-1 receptor antagonist for treatment of rheumatoid arthritis. Formulation 36 (2001) 191-203
7. Cohen S.B., et al. A multicentre, double blind, randomized, placebo controlled trial of anakinra (kineret), a recombinant interleukin 1 receptor antagonist, in patients with rheumatoid arthritis treated with background methotrexate. Ann Rheum Dis 63 (2004) 1062-1068
8. Bresnihan B., Alvaro-Gracia J.M., Cobby M., Doherty M., Domljan Z., Emery P., et al. Treatment of rheumatoid arthritis with recombinant human interleukin-1 receptor antagonist. Arthritis Rheum 41 (1998) 2196-2204
9. Langer H.E., and Missler-karger B. Kineret: efficacy and safety in daily clinical practice: an interim analysis of the kineret response assessment initiative (kreative) protocol. Int J Clin Pharmacol Res 23 (2003) 119-128
10. Jiang Y., Genant H.K., Watt I., Cobby M., Bresnihan B., and Aitchison R. A multicenter, double-blind, dose-ranging, randomized, placebo-controlled study of recombinant human interleukin-1 receptor antagonist in patients with rheumatoid arthritis: radioligic progression and correlation of Genant and Larsen scores. Arthritis Rheum 43 (2000) 10001-10009
11. Bailon P., Palleroni A., Schaffer C.A., Spence C.L., Fung W.J., Porter J.E., et al. Rational design of a potent, long-lasting form of interferon: A 40 kDa branched polyethylene glycol-conjugated interferon α-2a from the treatment of hepatitis C. Bioconjugate Chem 12 (2001) 195-202
12. Grace M., Youngster S., Gitlin G., Sydor W., Xie L., Westreich L., et al. Structural and biological characterization of pegylated recombinant IFN-α2b. J Interferon Cytokine Res 21 (2001) 1103-1105
13. Horan T., Wen J., Narhi L., Parker V., Garcia A., Arakawa T., et al. Dimerization of the extracellular domain of granulocyte-colony stimulating factor receptor by ligand binding: a monovalent ligand induces 2:2 complexes. Biochemistry 35 (1996) 4886-4896
14. Kendrick B.S., Kerwin B.A., Chang B.S., and Philo J.S. Online size-exclusion high performance liquid chromatography light scattering and differential refractometry methods to determine degree of polymer conjugation to proteins and protein-protein or protein-ligand association states. Anal Biochem 299 (2001) 136-146
15. Miron T., and Wilchek M. A simplified method for the preparation of succinimidyl carbonate polyethylene glycol for coupling to protein. Bioconjugate Chem 4 (1993) 568-569
16. Zailipsky S., Seltzar R., and Menon-Rudolph S. Evaluation of a new reagent for covalent attachment of polyethylene glycol to proteins. Biotechnol Appl Biochem 15 (1992) 100-114
17. Sun K.E., Ling S.G., Song X.G., Han B.G., and Ma X.K. Cloning of human interleukin-1 receptor antagonist cDNA and its expression in E. coli. J Cell Mol Immunol 14 (1998) 5-7
18. Laemmli U.K. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 227 (1970) 680-685
19. Bradford M.M. A rapid and sensitive method for the quantitation of microgram quantities of protein utilizing the principle of protein-dye binding. Anal Biochem 7 (1976) 248-254
20. Arend W.P., Welgus H.G., Thompson R.C., and Eisenberg S.P. Biological properties of recombinant human monocyte-derived interleukin 1 receptor antagonist. J Clin Invest 85 (1990) 1694-1697
21. Debye P.J.W. Light scattering in solution. J Appl Phys 15 (1944) 338-342
22. 3 U/ml of interleukin-2. J Immunol Methods 99 (1987) 7-11
23. Mosmann T. Rapid colorimetric assay for cellular growth and survival: Application to proliferation and cytotoxicity assays. J Immunol Methods 65 (1983) 55-63
24. Boraschi D., Bossù P., Macchia G., Ruggiero P., and Tagliabue A. Structure-function relationship in the IL-1 family. Frontiers Biosci 1 (1995) 270-308
25. Zalipsky S., Seltzer R., and Menon-Rudolph S. Evaluation of a new reagent for covalent attachment of polyethylene glycol to proteins. Biotechnol Appl Biochem 15 (1992) 100-114
26. Roberts M.J., Bentley M.D., and Harris J.M. Chemistry for peptide and protein PEGylation. Adv Drug Delivery Rev 54 (2002) 459-476
27. Harris J.M., and Kozlowski A. Improvements in protein PEGylation: pegylated interferons for treatment of hepatitis C. J Controlled Release 72 (2001) 217-224
28. Wylie D.C., Voloch M., Lee S., Liu Y.H., Cannon-Carlson S., Cutler C., et al. Carboxyalkylated histidine is a pH-dependent product of pegylation with SC-PEG. Pharm Res 18 (2001) 1354-1360
29. Harris J.M., and Chess R.B. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov 2 (2003) 214-221
30. Molineux G. Pegylation: engineering inproved pharmaceuticals for enhanced therapy. Cancer Treat Rev Suppl. A (2002) 13-16
31. Oliva A., Farina J.B., and Llabrés M. Measurement of uncertainty in peptide molecular weight determination using size-exclusion chromatography with multi-angle laser light-scattering detection and matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. Anal Chim Acta 512 (2004) 103-110
32. Gong X.W., Wei D.Z., He M.L., and Xiong Y.C. Lowry method for the determination of pegylated proteins: the error, it reason, and a method for emilinating it. Anal Biochem 354 (2006) 157-158
33. Basu A., Yang K., Wang M.L., Liu S., Chintala R., Palm T., et al. Structure-function engineering of interferon-β-1b for improving stability, solubility, potency, immunogenicity, and pharmacokinetic properties by site-selective mono-PEgylation. Bioconjugate Chem 17 (2006) 618-630
34. Reddy K.R., Modi M.W., and Pedder S. Use of peginterferon alfa-2a (40 KD) (Pegasys) for the treatment of Hepatitis C. Adv Drug Delivery Rev 54 (2002) 571-586
35. Glue P., et al. Pegylated interferon-α2b: Pharmacokinetics, pharmacodynamics Safety and preliminary efficacy data. Clin Pharmacol Ther 68 (2000) 556-567