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Current Trends in Biotechnology and Pharmacy Vol. 6 (2) 229-240 April 2012, ISSN 0973-8916 (Print), 2230-7303 (Online) Acknowledgement The authors thank Dr Parvin Shariati for critical reading of the manuscript. Funding: We gratefully acknowledge the financial grant received from the National Institute of Genetic Engineering and Biotechnology (No. 298). References 1. Baker, D.P., Lin, E.Y., Lin, K., Pellegrini, M., Petter, R.C., Chen, L.L., Arduini, R.M.,Brickelmaier, M., Wen, D., Hess, D.M., Chen, L., Grant, D., Whitty, A., Gill, A., Lindner, D.J. and Pepinsky, R.B. (2006). N-Terminally PEGylated Human Interferonβ-1a with Improved Pharmacokinetic Properties and in Vivo Efficacy in a Melanoma Angiogenesis Model. Bioconj Chem, 17(1):179-188. 2. Chevaliez, S. and Pawlotsky, J.M. (2007). Interferon-based therapy of hepatitis C. Adv Drug Del Rev, 59(12):1222-1241. 3. Souvignet, C., Lejeune, O. and Trepo, C. (2007). Interferon-based treatment of chronic hepatitis C. Biochimie, 89(6-7):894- 898. 4. Tayal, V. and Kalra, B.S. (2008). Cytokines and anti-cytokines as therapeutics—an update. Eur J Pharmaco, 579(1-3):1-12. 5. Esmata, G. and Abdel Fattah, S. (2009). Evaluation of a novel pegylated interferon alpha-2a in Egyptian patients with chronic hepatitis C– genotype 4. Digest Liver Dis, Suppl. 3:17-19. 6. Van Beers, M.M.C., Sauerborn, M., Gilli, F., Hermeling, S., Brinks, V., Schellekens, H. and Jiskoo, W. (2010). Hybrid transgenic immune tolerant mouse model for assessing the breaking of B cell tolerance Ahmad Abolhasani et al 238 by human interferon beta. J Immunol Methods, 352(1-2):32-37. 7. Harris, J.M. and Chess, R.B. (2003). Effect of pegylation on pharmaceuticals. Nat Rev Drug Discov, 2(3):214-221. 8. Veronese, F.M. and Pasut, G. (2005). PEGylation, successful approach to drug delivery. Drug Discov Today, 10(21):1451- 1458. 9. Roberts, M.J., Bentley, M.D. and Harris, J.M. (2002). Chemistry for peptide and protein PEGylation. Adv Drug Deli Rev, 54(4):459-476. 10. Caliceti, P. and Veronese, F.M. (2003). Pharmacokinetic and biodistribution properties of poly(ethylene glycol)-protein conjugates. Adv Drug Del Rev, 55:1261- 1277. 11. Na, D.H., Youn, Y.S., Lee, I.B., Park, E.J., Park, C.J. and Lee, K.C. (2006). Effect of molecular size of PEGylated recombinant human epidermal growth factor on the biological activity and stability in rat wound tissue. Pharm Dev Technol, 11:513-519. 12. Monkarsh, S.P., Ma, Y., Aglione, A., Bailon, P., Ciolek, D., Debarbieri, B., Graves, M. C., Hollfelder, K., Michel, H., Palleroni, A., Porter, J.E., Russoman, E., Roy, S. and Pan, Y.C. (1997). Positional isomers of monopegylated interferon alpha-2a: isolation, characterization, and biological activity. Anal Biochem, 247:434-440. 13. Bailon, P., Palleroni, A., Schaffer, C.A., Spence, C.L., Fung, W.J., Porter, J.E., Ehrlich, G.K., Pan, W., Xu, Z.X., Modi, M.W., Farid, A., Berthold, W. and Graves, M. (2001). Rational design of a potent, longlasting form of interferon: a 40 kDa branched polyethylene glycol conjugated interferon alpha-2a for the treatment of hepatitis C. Bioconj Chem, 12:195-202.
Current Trends in Biotechnology and Pharmacy Vol. 6 (2) 229-240 April 2012, ISSN 0973-8916 (Print), 2230-7303 (Online) 14. Wang, Y.S., Youngster, S., Grace, M., Bausch, J., Bordens, R. and Wyss, D.F. (2002). Structural and biological characterization of pegylated recombinant interferon alpha-2b and its therapeutic implications. Adv Drug Del Rev, 54:547- 570. 15. Reddy, K.R., Modi, M.W. and Pedder, S. (2002). Use of peginterferon alfa-2a (40 KD) (Pegasys) for the treatment of hepatitis C. Adv Drug Del Rev, 54:571-586. 16. Daruich, J. (2010). Chronic hepatitis C treatment in native patient. J Annals Hepatol, 9:S65-S71. 17. Caserman, S., Kusterle, M., Kunstelj, M., Milunovic´, T., Schiefermeier, M., Jevševar, S. B. and Porekar, V.G. (2009). Correlations between in vitro potency of polyethylene glycol–protein conjugates and their chromatographic behavior. Anal Biochem, 389:27–31. 18. Jo, Y.W., Youn, Y.S., Lee, S.H., Kim, B.M., Kang, S.H., Yoo, M., Choi, E.C. and Lee, K.C. (2006). Long-acting interferon-alpha 2a modified with a trimer-structured polyethylene glycol: preparation, in vitro bioactivity, in vivo stability and pharmacokinetics. Int J Pharm, 309:87-93. 19. Na, D.H., Park, E.J., Jo, Y.W. and Lee, K.C. (2008). Capillary electrophoretic separation of high-molecular-weight poly(ethylene glycol)-modified proteins. Anal Biochem, 373:207-212. 20. Pepinsky, R.B., Lepage, D.J., Gill, A., Chakraborty, A., Vaidyanathan, S., Green, M., Baker, D.P., Whalley, E., Hochman, P.S. and Martin, P. (2001). Improved pharmacokinetic properties of a polyethylene glycol-modified form of interferon-ß-1a with preserved in Vitro bioactivity. J Pharmacol Exp Ther, 297:1059-1066. Interferon Beta-1a PEGylation 239 21. Pepinsky, R.B., Lepage, D.J., Gill, A., Chakraborty, A., Vaidyanathan, S., Green, M., Baker, D.P., Whalley, E., Hochman, P.S. and Martin, P. (2001). Improved pharmacokinetic properties of a polyethylene glycol- modified form of interferon-ß-1a with preserved in vitro bioactivity. J Pharmacol Exp Ther, 297:1059-1066. 22. Katre, N. and Knauf, M.J. (1990). Solubilization of immunotoxins for pharmaceutical compositions using polymer conjugation. U. S. Patent. 4,917,888. 23. Arduini, R.M., Li, Z., Rapoza, A., Gronke, R., Hess, D.M., Wen, D., Miatkowski, K., Coots, C., Kaffashan, A., Viseux N., Delaney J., Domon B., Young, C.N., Boynton, R., Chen, L.L., Chen, L., Betzenhauser, M., Miller, S., Gill, A., Pepinsky, R.B., Hochman, P. S. and Baker, D.P. (2004). Expression, purification, and characterization of rat interferon-b,and preparation of an N-terminally PEGylated form with improved pharmacokinetic parameters. Protein Exp Purif, 34:229-242. 24. Mager, D.E., Neuteboom, B. and Jusko, W.J. (2005). Pharmacokinetics and pharmacodynamics of PEGylated IFN-ß- 1a following subcutaneous administration in monkeys. Pharm Res, 22:58-61. 25. Basu, A., Yang, K., Wang, M., Liu, S., Chintala, R., Palm, T., Zhao, H., Peng, P., Wu, D., Zhang, Z., Hua, J., Hsieh, M.C., Zhou, J., Petti, G., Li, X., Janjua, A., Mendez, M., Liu, J., Longley, C., Zhang, Z., Mehlig, M., Borowski, V., Viswanathan, M. and Filpula, D. (2006). Structure-function engineering of interferon-â-1a for improving stability, solubility, potency, immunogenicity, and pharmacokinetics properties by siteselective mono-PEGylation. Bioconj Chem, 17:618-630.
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