Preparation and characterization of monopegylated human granulocyte-macrophage colony-stimulating factor

Journal of Interferon and Cytokine Research

Volumn 28, Issue 2, 2008, Pages 101-112

  Lee, Darin L ^a   Sharif, Isha ^a   Kodihalli, Shantha ^a,b   Stewart, Donald I H ^a   Tsvetnitsky, Vadim ^a  

^a Cangene Corporation   (Canada)

^b Cangene Corporation   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

AMINE; GRANULOCYTE MACROPHAGE COLONY STIMULATING FACTOR; MACROGOL;

AMINO TERMINAL SEQUENCE; ANIMAL CELL; ANIMAL EXPERIMENT; ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; BIOASSAY; CELL PROLIFERATION; COLORIMETRY; CONTROLLED STUDY; GEL PERMEATION CHROMATOGRAPHY; HALF LIFE TIME; HUMAN; HUMAN CELL; IN VITRO STUDY; MALE; MASS SPECTROMETRY; MOLECULAR WEIGHT; NONHUMAN; PEPTIDE MAPPING; POLYACRYLAMIDE GEL ELECTROPHORESIS; PRIORITY JOURNAL; RAT; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

ANIMALS; BIOLOGICAL ASSAY; CELL PROLIFERATION; CHROMATOGRAPHY; GRANULOCYTE MACROPHAGE COLONY-STIMULATING FACTORS, RECOMBINANT; GRANULOCYTE-MACROPHAGE COLONY-STIMULATING FACTOR; HUMANS; MASS SPECTROMETRY; PEPTIDE MAPPING; POLYETHYLENE GLYCOLS; RATS;

RATTUS;

EID: 39449114209     PISSN: 10799907     EISSN: None     Source Type: Journal    
DOI: 10.1089/jir.2006.0167     Document Type: Article

References (51)

1. Alvarez P, Buscaglia CA, Campetella O. 2004. Improving protein pharmacokinetics by genetic fusion to simple amino acid sequences. J Biol Chem 279:3375-3381.
2. Arellano M, K Waller E. 2004. Granulocyte-macrophage colony-stimulating factor and other cytokines: as adjuncts to cancer immunotherapy, stem cell transplantation, and vaccines. Curr Hematol Rep 3:424-431.
3. Armitage JO. 1998. Emerging applications of recombinant human granulocyte-macrophage colony-stimulating factor. Blood 92:4491-4508.
4. Bailon P, Palleroni A, Schaffer CA, Spence CL, Fung WJ, Porter JE, Ehrlich GK, Pan W, Xu ZX, Modi MW, Farid A, Berthold W, Graves M. 2001. Rational design of a potent, long-lasting form of interferon: a 40 kDa branched polyethylene glycol-conjugated interferon alpha-2a for the treatment of hepatitis C. Bioconjug Chem 12:195-202.
5. Brown PA, Angel PA. 2005. Granulocyte-macrophage colony-stimulating factor as an immune-based therapy in HIV infection. J Immune Based Ther Vaccines 3:3.
6. Caliceti P, Veronese FM. 2003. Pharmacokinetic and biodistribution properties of poly(ethylene glycol)-protein conjugates. Adv Drug Deliv Rev 55:1261-1277.
7. Clark-Lewis I, Lopez AF, To LB, Vadas MA, Schrader JW, Hood LE, Kent SB. 1988. Structure-function studies of human granulocyte-macrophage colony-stimulating factor. Identification of residues required for activity. J Immunol 141:881-889.
8. Cottler-Fox MH, Lapitot T, Petit I, Kollet O, Dipersio JF, Link D Devine S. 2003. Stem cell mobilization. Hematology 419-437.
9. high murine dendritic cells in vivo: a comparative analysis with Flt3 ligand. J Immunol 165:49-58.
10. Deb G, Donfrancesco A, Sio LD, Cozza R, Castellano A, Paole F, Helson L. 1998. Shortened time to recovery from chemotherapy induced neutropenia in pediatric patients with high dose combined cytokines. Anticancer Res 18:489-492.
11. Dhalluin C, Ross A, Leuthold LA, Foser S, Gsell B, Müller F, Senn H. 2005. Structural and biophysical characterization of the 40 kDa PEG-interferon-alpha2a and its individual positional isomers. Bioconjug Chem 16:504-517.
12. Doherty DH, Rosendahl MS, Smith DJ, Hughes JM, Chlipala EA, Cox GN. 2005. Site-specific PEGylation of engineered cysteine analogues of recombinant human granulocyte-macrophage colony-stimulating factor. Bioconjug Chem 16:1291-1298.
13. Duttaroy A, Kanakaraj P, Olsborn BL, Schneider H, Pickeral OK, Chen C, Ahang G, Kaithamana S, Singh M, Chulingkamp R, Crossan D, Bock J, Kaufman TE, Reavey P, Carey-Barber M, Krishnan SR, Garcia A, Murphy K, Siskind JK, Mclean MA, Cheng S, Ruben S, Birse CE, Blondel O. 2005. Development of a long-acting insulin analog using albumin fusion technology. Diabetes 54:251-258.
14. Eberhardt MO, Frank R, Kratje R, Etcheverrigaray M. 2003. Identification of two potential receptor-binding sites for hGM-CSF. Braz J Chem Eng 20:15-20.
15. Edwards CK, Martin SW, Seely J, Kinstler O, Buckel S, Bendele AM, Ellen Cosenza M, Feige U, Kohno T. 2003. Design of PEGylated soluble tumor necrosis factor receptor type I (PEG-sTNF-RI) for chronic inflammatory diseases. Adv Drug Deliv Rev 55:1315-1336.
16. Foser S, Schacher A, Weyer KA, Brugger D, Dietel E, Marti S, Schreitmuller T. 2003. Isolation, structural characterization, and antiviral activity of positional isomers of monopegylated interferon alpha-2a (PEGASYS). Protein Expr Purif 30:78-87.
17. Francis GE, Fisher D, Delgado C, Malik F, Gardiner A, Neale D. 1998. PEGylation of cytokines and other therapeutic proteins and peptides: the importance of biological optimisation of coupling techniques. Int J Hematol 68:1-18.
18. Gerlier D, Thomasset N. 1986. Use of MTT colorimetric assay to measure cell activation. J Immunol Methods 94:57-63.
19. Grace MJ, Cutler D. 2004. Pegylating IFNs at his-34 improves the in vitro antiviral activity through the JAK/STAT pathway. Antivir Chem Chemother 15:287-297.
20. Grace M, Youngster S, Gitlin G, Sydor W, Xie L, Westereich L, Jacobs S, Brassard D, Bausch, Borderns R. 2001. Structural and biologic characterization of pegylated recombinant IFN-α2b. J Interferon Cytokine Res 21:1103-1115.
21. Groves RW, Schmidt-Lucke JA. 2000. Recombinant human GM-CSF in the treatment of poorly healing wounds. Adv Skin Wound Care 13:107-112.
22. Guerra PI, Acklin C, Kosky AA, Davis JM, Treuheit MJ, Brems DN. 1998. PEGylation prevents the N-terminal degradation of megakaryocyte growth and development factor. Pharm Res 15:1822-1827.
23. Hamilton JA. 2002. GM-CSF in inflammation and autoimmunity. Trends Immunol 23:403-408.
24. Harris JM, Chess RB. 2003. Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov 2:214-221.
25. Kinstler OB, Brems DN, Lauren SL, Paige AG, Hamburger JB, Treuheit MJ. 1996. Characterization and stability of N-terminally PEGylated rhG-CSF. Pharm Res 13:996-1002.
26. Kinstler O, Molineux G, Treuheit M, Ladd D, Gegg C. 2002. Mono-N-terminal poly(ethylene glycol) protein conjugates. Adv Drug Deliv Rev 54:477-485.
27. Kitamura T, Tange T, Terasawa T, Chiba S, Kuwaki T, Miyagawa K, Piao YF, Miyzaono K, Urabe A, Takaku F. 1989. Establishment and characerization of a unique human cell line that proliferates dependently on GM-CSF, IL-3 or erythropoietin. J Cell Physiol 140:323-334.
28. Knüsli C, Delgado C, Malik F, Domine M, Tejedor MC, Irvine AE, Fisher D, Francis, GE. 1992. Polyethylene glycol (PEG) modification of granulocyte-macrophage colony stimulating factor (GM-CSF) enhances neutrophil priming activity but not colony stimulating activity. Br J Haematol 82:654-663.
29. Korzenik JR, Dieck Graefe BK, Valentine JF, Hausman DF, Gilbert MJ. 2005. Sargramostim for active Crohn's disease. N Engl J Med 352:2193-2201.
30. Kurfürst MM. 1992. Detection and molecular weight determination of polyethylene glycol-modified hirudin by staining after sodium dodecyl sulfate-polyacrylamide gel electrophoresis. Anal Biochem 2000:244-248.
31. Laemmli UK. 1970. Cleavage of structural proteins during the assembly of the head of bacteriophage T4. Nature 227:680-685.
32. Lee F, Yokota T, Otsuka T, Giemmel L, Larson L, Luh J, Arai K-I, Rennick D. 1985. Isolation of cDNA for a human granulocyte-macrophage colony-stimulating factor by functional expression in mammalian cells. Proc Natl Acad Sci USA 82:4360-4364.
33. Lee H, Park TG. 2002. Preparation and characterization of mono-PEGylated epidermal growth factor: evaluation of in vitro biological activity. Pharm Res 19:845-851.
34. Lyne PD, Bamborough P, Duncan D, Richards WG. 1995. Molecular modeling of the GM-CSF and IL-3 receptor complexes. Protein Sci 4:2223-2233.
35. Malik F, Delgado C, Kņsli C, Irvine AE, Fisher D, Francis GE. 1992. Polyethylene glycol (PEG)-modified granulocyte-macrophage colony-stimulating factor (GM-CSF) with conserved biological activity. Exp Hematol 20:1028-1035.
36. Martinez-Moczygemba MM, Huston DP. 2003. Biology of common beta receptor-signaling cytokines: IL-3, IL-5, and GM-CSF. J Allergy Clin Immunol 112:653-665.
37. Mery L, Girot R, Aractingi S. 2004. Topical effectiveness of molgramostim (GM-CSF) in sickle cell leg ulcers. Dermatology 208:135-137.
38. Mire-Sluis AR, Das RG, Thorpe R. 1995. The international standard for granulocyte-macrophage colony stimulating factor (GM-CSF). Evaluation in an international collaborative study. J Immunol Methods 179:127-135.
39. Monfardini C, Kieber-Emmons T, Voet D, Godillot AP, Weiner DB, Williams WV. 1996. Rational design of granulocyte-macrophage colony-stimulating factor antagonist peptides. J Biol Chem 271(6):2966-2971.
40. Morpurgo M, Veronese FM. 2004. Conjugates of peptides and proteins to polyethylene glycols. Methods Mol Biol 283:45-70.
41. Nucci ML, Shorr R, Buchowski A. 1991. The therapeutic value of poly(ethylene glycol)-modified proteins. Adv Drug Deliv Rev 6:133-151.
42. Putney SD. 1998. Encapsulation of proteins for improved delivery. Curr Opin Chem Biol 2:548-552.
43. Roberts MJ, Bentley MD, Harris JM. 2002. Chemistry for peptide and protein PEGylation. Adv Drug Deliv Rev 54:459-476.
44. Robinson SN, Talmadge JE. 2002. Sustained release of growth factors. In Vivo 16:535-540.
45. Seely J, Richey C. 2001. Use of ion-exchange chromatography and hydrophobic interaction chromatography in the preparation and recovery of polyethylene glycol-linked proteins. J Chromatogr 908:235-241.
46. Sherman MR, Williams LD, Saifer MGP, French JA, Kwak LW, Oppenheim JJ. 1997. Conjugation of high molecular weight poly(ethylene glycol) to cytokines: granulocyte-macrophage colony-stimulating factors as model substrates. In: Harris JM, Zalipsky S, editors. Poly(ethylene glycol) Chemistry and Biological Applications. pp 155-169.
47. Sinclair AM, Elliott S. 2005. Glycoengineering: the effect of glycosylation on the properties of therapeutic proteins. J Pharm Sci 2005;94:1626-1635.
48. Sylvester RK. 2002. Clinical applications of colony-stimulating factors: a historical perspective. Am J Health Syst Pharm 59:S6-S12.
49. Walter MR, Cook WJ, Ealick SE, Nagabhushan TL, Trotta PP, Bugg CE. 1992. Three-dimensional structure of recombinant human granulocyte-macrophage colony-stimulating factor. J Mol Biol 224:1075-1085.
50. Wong SS. 1991. Reactive groups of proteins and their modifying agents. In: Chemistry of Protein Conjugation and Cross-Linking. Boca Raton: CRC Press. p, 13.
51. Yang BB, Lum PK, Hayashi MM, Roskos LK. 2004. Polyethylene glycol modification of filgrastim results in decreased renal clearance of the protein in rats. J Pharm Sci 93:1367-1373.