Preview

Fine Chemical Technologies

Advanced search

Bacterial endotoxins properties and methods of removing them from biopharmaceutical drugs

Full Text:

Abstract

The production of biopharmaceutical proteins by means of Escherichia coli cultivation leads to contamination with bacterial endotoxins which are very toxic and pyrogenic impurities. The final product purification from these impurities is one of the most important tasks in the production of biopharmaceutical drugs. However, isolation of proteins from cellular biomass results in the formation of strong endotoxin-protein complexes that considerably complicate the task of obtaining pharmaceutical safely drugs. The goal of the present mini-review consisted in considering and discussing effective methods of removing bacterial endotoxins from protein solutions on the basis of their chemical and biological properties.

About the Authors

A. S. Zhuravko
M.V. Lomonosov Moscow State University of Fine Chemical Technologies, 86, Vernadskogo pr., Moscow 119571
Russian Federation


V. I. Shvets
M.V. Lomonosov Moscow State University of Fine Chemical Technologies, 86, Vernadskogo pr., Moscow 119571
Russian Federation


References

1. Chen L., Mozier N. Comparison of Limulus amebocyte lysate test methods for endotoxin measurement in protein solutions // J. Pharm. & Biomed. Analysis. 2013. V. 80. P. 180-185.

2. Daneshiam M., Guenther A., Wendel A., Hartung T., Von Aulock S. In vitro pyrogen test for toxic or immunomodulatory drugs // J. Immunol. Meth. 2006. V. 313. P. 169-175.

3. Levin J., Bang F.B. The role of endotoxin in the extracellular coagulation of Limulus blood // Bull. Johns Hosp. 2004. V. 115. P. 265-274.

4. Erridge C., Bennett-Guerrero E., Poxton I.R. Structure and function of lipopolysaccharides // Microbes & Infection. 2005. V. 4. P. 837-851.

5. Ogikubo Y., Ogikubo Y., Norimatsu M., Noda K., Takahashi J., Inotsume M., Tsuchiya M. Evaluation of the bacterial endotoxin test for quantification of endotoxin contamination of porcine vaccines // Biologicals. 2004. V. 32. P. 88-93.

6. Fiske J.M., Ross A., Meid R.K., McMichael J.C., Arumugham M. Method for reducing endotoxin in Moraxella catarrhalis UspA2 protein preparations // J. Chrom. B. 2007. V. 753. P. 269-278.

7. Ситников А.Г., Травина Л.А., Багирова В.Л. ЛАЛ-тест. Современные подходы к определению пирогенности. М., 1997. 96 с.

8. Lin M.F., Williams C., Murray M.V., Ropp P.A. Removal of lipopolysaccharides from protein lipopolysaccharide complex by nonflammable solvents // J. Chrom. B. 2005. V. 816. P. 167-174.

9. Co T.U.I., Hope D., Scrift M.H., Powers J. Purified pyrogen from Eberthella typhosa. A preliminary report on its preparation and its chemical and biologic characterization // J. Lab. Clin. Med. 1944. V. 29. P. 58-62.

10. Magalhaes P.O., Lopes A.M., Mazzola P.G., Rangel-Yagui C., Penna T.C.V. Pessoa A.Jr. Methods of endotoxin removal from biological preparation: A review // J. Pharm. Pharmaceut. Sci. 2007. V. 10. P. 388-404.

11. Hirayama C., Sakata M. Chromatographic removal of endotoxin from protein solutions by polymer particles // J. Chrom. B. 2002. V. 781. P. 419-432.

12. Raetz C.R., Ulevitch R.J., Wright S.D., Sibley C.H., Ding A., Nathan C.F. Gram-negative endotoxin: Аn extraordinary lipid with profound effects on eukaryotic signal transduction // FASEB J. 1991. V. 5. № 12. P. 2652-2660.

13. Petsch D., Anspach F.B. Endotoxin removal from protein solutions // J. Biotechnol. 2005. V. 76. P. 97-119.

14. Ohno N., Morrison D.C. Lipopolysaccharide interaction with lysozyme: Binding of lipopolysaccharide to lysozyme and inhibition of lysozyme enzymatic activity // J. Biol. Chem. 1989. V. 264. P. 4434-4441.

15. Hou K.C., Zaniewski R. Depyrogenation by endotoxin removal with positively charged depth filter cartridge // J. Parenteral Sci. Technol. 1990. V. 44. P. 204-209.

16. Forehand J.R., Pabst M.J., Phillips W.A., Johnston J.B. Lipopolysaccharide priming of human neutrophils for an enhanced respiratory burst. Role of intracellular free calcium // J. Clin. Investig. 1989. V. 83. P. 74-83.

17. Rietschel E.T., Kirikae T., Schade F.U., Mamat U., Schmidt G, Loppnow H., Ulmer A.J., Zahringer U., Seydel U., Di Padova F. Bacterial endotoxin: Molecular relationships of structure to activity and function // FASEB J. 1994. V. 8. P. 217-225.

18. Schromm A.B., Brandenburg K., Loppnow H., Moran A.P., Koch M.H.J., Rietschel E.T., Seydel U. Biological activities of lipopolysaccharides are determined by the shape of their lipid A portion // Eur. J. Biochem. 2000. V. 267. P. 2008-2013.

19. Sharma S.K. Endotoxin detection and elimination in biotechnology // Biotechnol. Appl. Biochem. 1986. V. 1. P. 5-22.

20. Reichelt P., Schwarz C., Donzeau M. Single step protocol to purify recombinant proteins with low endotoxin contents // Protein Expr. Purif. 2006. V. 46. P. 483-488.

21. Sweadner K.J., Forte M., Nelsen L.L. Filtration removal of endotoxin [pyrogens] in solution in different states of aggregation // Appl. Environ. Microbiol. 1977. V. 34. № 4. P. 382-385.

22. Berthold W., Walter J. Protein purification: Aspects of processes for pharmaceutical products // Biologicals. 1994. V. 22. P. 135-150.

23. Гусаров Д.А. Способы очистки биофармацевтических белков от эндотоксинов клеточной стенки // Биофарм. журн. 2009. Т. 1. № 3. С. 10-17.

24. Shukla A.K., Schauer R. Determination of 3-deoxy-D-manno-octulosonic acid (KDO), N-acetylneuraminic acid, and their derivatives by ion-exchange liquid chromatography // Carbohydrate Res. 1985. V. 140. P. 1-8.

25. Chen R.H., Huang C.-Jr., Newton B.S., Ritter G., Old L.J., Batt C.A. Factors affecting endotoxin removal from recombinant therapeutic proteins by anion exchange chromatography // Protein Expr. & Purif. 2009. V. 64. № 1. P. 76-81.

26. Brass D.M., Savov J.D., Whitehead G.S., Maxwell A.B., Schwartz D.A. LPS binding protein is important in the airway response to inhaled endotoxin // J. Allergy & Clin. Immunol. 2004. V.114. № 3. P. 586-592.

27. Wilson M.J., Haggart C.L., Gallagher S.P., Walsh D. Removal of tightly bound endotoxin from biological products // J. Biotechnol. 2001. V. 88. № 1. P. 67-75.

28. Dismer F., Hubbuch J. 3D structure-based protein retention prediction for ion-exchange chromatography // J. Chromatogr. A. 2010. V. 1217. № 8. P. 1343-1353.

29. Oelmeier S.A., Dismer, F., Hubbuch J. Molecular dynamics simulations on aqueous two-phase systems - Single PEG-molecules in solution // BMC Biophys. 2012. V. 5. P. 1-14.

30. Anspach F.B. Endotoxin removal by affinity sorbents // J. Biochem. & Biophys. Meth. 2001. V. 49. P. 665-681.

31. Hjelmeland L.M., Klee W.A., Osborne J.C. A new class of nonionic detergents with a gluconamide polar group // Anal. Biochem. 1983. V. 15. № 130. P. 485-490.

32. Kang Y., Luo R. G. Effects of ionic strength and pH on endotoxin removal efficiency and protein recovery in an affinity chromatography // Process Biochem. 2000. V. 36. № 1-2. P. 85-92.

33. Molvig J., Baek L. Removal of endotoxin from culture media by a polymyxin B sepharose column // J. Immunol. 1987. V. 26. P. 611-619.

34. Issekutz A. Removal of gram-negative endotoxin from solutions by affinity chromatography // J. Immunol. Meth. 1983. V. 61. P. 275-281.

35. Wei Z., Huang W., Li J., Hou G., Fang J., Yuan Z. Studies on endotoxin removal mechanism of adsorbents with amino acid ligands // J. Chrom. B. 2007. V. 852. P. 288-292.

36. Мартынов В.Б. Экстракция органическими кислотами и их щелочами. М.: Энергоатомиздат, 1989. 272 c.

37. Зотов Ю.А. Экстракция внутрикомплексных соединений. М.: Наука. 1968. 313 c.

38. Liu C.L., Kamei D.T., King J.A., Wang D.I.C., Blankschtein D. Separation of proteins and viruses using two-aqueous micellar systems // J. Chrom B. 1998. V. 711. P. 127-138.

39. Lopes A.M., Magalhaes P.O., Mazzola P.G., Rangel-Yagui C., Penna T.C.V. Pessoa A. LPS removal from an E. coli fermentation broth using aqueous two-phase micellar system // Biotechnol. Prog. 2010. V. 26. № 6. P. 1644-1653.

40. Liu C.L., Nikas Y.J., Blankschtein D. Novel bioseparations using two-phase aqueous micellar systems // Biotechnol. Bioeng. 1996. V. 52. P. 185-192.

41. Aida Y., Pabst M.J. Removal of endotoxin from protein solutions by phase separation using Triton X-114 // J. Immunol. Meth. 1990. V. 14. № 6. P. 191-195.


For citation:


Zhuravko A.S., Shvets V.I. Bacterial endotoxins properties and methods of removing them from biopharmaceutical drugs. Fine Chemical Technologies. 2014;9(4):27-33. (In Russ.)

Views: 73


Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.


ISSN 2410-6593 (Print)
ISSN 2686-7575 (Online)