Optimization and validation of a virus filtration process for efficient removal of viruses from urokinase solution prepared from human urine

Journal of Microbiology and Biotechnology

Volumn 14, Issue 1, 2004, Pages 140-147

  Kim, In Seop ^a   Choi, Yong Woon ^b   Lee, Sung Rae ^b  

^a Hannam University   (South Korea)

^b Green Cross Company   (South Korea)

Author keywords

Filtration; Hepatitis A virus; Parvovirus; Urokinase; Validation; Virus removal

Indexed keywords

PLASMINOGEN ACTIVATOR; POLYVINYLIDENE FLUORIDE; UROKINASE;

ARTICLE; BIOCHEMISTRY; BIOFILTRATION; BOVINE DIARRHEA VIRUS; BOVINE HERPES VIRUS; CONTROLLED STUDY; ENZYME ISOLATION; EXPERIMENTAL MODEL; FIBRINOLYSIS; HEPATITIS A VIRUS; HUMAN; MALE; MEMBRANE FILTER; MURINE ENCEPHALOMYELITIS VIRUS; NONHUMAN; PHYSICAL CHEMISTRY; PORCINE PARVOVIRUS; PROCESS MODEL; PROCESS OPTIMIZATION; SCALE UP; URINE; VALIDATION PROCESS; VIRUS ENVELOPE; VIRUS VIRULENCE;

BOVINAE; BOVINE VIRAL DIARRHEA VIRUS 1; ENCEPHALOMYOCARDITIS VIRUS; HEPATITIS A VIRUS; HERPESVIRIDAE; HUMAN HEPATITIS A VIRUS; MURINAE; PARVOVIRUS; PORCINE PARVOVIRUS; SUIDAE;

EID: 1542375323     PISSN: 10177825     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. Andrewes, C. 1989. Andrewes Viruses of Vertebrates, pp. 120-145. Balliere Tindal, London, U.K.
2. Arahana, H. 2001. Viral clearance strategies for biopharmaceutical safety. Part 2: Filtration for viral clearance. Biol. Pharm. February: 32-43.
3. Aranha-Creado, H., J. Peterson, and P. Y. Huang. 1998. Clearance of murine leukaemia virus from monoclonal antibody solutions by a hydrophilic PVDF microporous membrane filter. Biologicals 26: 167-172.
4. Aranha-Creado, H., K. Oshima, S. Jafari, G. Honward, Jr. and H. Brandwein. 1997. Virus retention by a hydrophilic triple-layer PVDF microporous membrane filter. PDA J. Pharm. Sci. Technol. 51: 119-124.
5. max testing for practical microfiltration train scale-up in biopharmaceutical processing. Pharm. Technol. September: 64-76.
6. Bennion, D. W., L. J. Wright, R. A. Watt, A. A. Whiting, and J. F. Carlquist. 1998. Optimal recovery of cytomegalovirus from urine as a function of specimen preparation. Diagn. Microbiol. Infect. Dis. 31: 337-342.
7. Borovec, S., C. Broumis, W. Adcock, R. Fang, and E. Uren. 1998. Inactivation kinetics of model and relevant blood-borne viruses by treatment with sodium hydroxide and heat. Biologicals 26: 237-244.
8. Cao, X. J., J. H. Zhou, Z. H. Huang, X. Y. Wu, and B. K. Hur. 2002. Preparation of high-purity urokinase using single-step hydrophobic interaction chromatography with p-aminobenzamidine ligand. J. Microbiol. Biotechnol. 12: 196-203.
9. Coulepis, A. G., S. A. Locarnini, N. I. Lehmann, and I. D. Gust. 1980. Detection of hepatitis A virus in the feces of patients with naturally acquired infections. J. Infect. Dis. 141: 151-156.
10. Eibl, J., N. Barrett, T. Hämmerle, and F. Dorner. 1996. Nanofiltration of immunoglobulin with 35-nm filters fails to remove substantial amounts of HCV. Biologicals 24: 285-287.
11. Graf, E. G., E. Jander, A. West, H. Pora, and H. Aranha-Creado. 1999. Virus removal by filtration. Dev. Biol. Stand. 99: 84-89.
12. Kim, I. S., H. G. Eo, C. E. Chang, and S. Lee. 2000. Partitioning and inactivation of viruses by cold ethanol fractionation and pasteurization during manufacture of albumin from human plasma. J. Microbiol. Biotechnol. 10: 858-864.
13. Kim, I. S., Y. W. Choi, H. S. Woo, C. E. Chang, and S. Lee. 2000. Solvent/detergent inactivation and chromatographic removal of human immunodeficiency virus during the manufacturing of a high purity antihemophilic factor VIII concentrate. J. Microbiol. 38: 187-191.
14. Kim, I. S., Y. W. Choi, S. R. Lee, H. B. Cho, H. G. Eo, H. S. Woo, C. E. Chang, and S. Lee. 2001. Improvement of virus safety of a human intravenous immunoglobulin by low pH incubation. J. Microbiol. Biotechnol. 11: 619-627.
15. Kim, I. S., Y. W. Choi, S. R. Lee, H. S. Woo, and S. Lee. 2001. Removal and inactivation of viruses during manufacture of a high purity antihemophilic factor VIII concentrate from human plasma. J. Microbiol. Biotechnol. 11: 497-503.
16. Kim, I. S., Y. W. Choi, S. R. Lee, M. S. Lee, K. H. Huh, and S. Lee. 2001. Removal and inactivation of hepatitis A virus during manufacture of a high purity antihemophilic factor VIII concentrate from human plasma. J. Microbiol. 39: 67-73.
17. Levy, J. A., H. Fraenkel-Conrat, and R. A. Owens. 1994. Virology, pp. 153-160. 3rd ed. Prentice Hall, Englewood Cliffs, NJ, U.S.A.
18. Melchers, W. J., R. Schift, E. Stolz, J. Lindeman, and W. G. Quint. 1989. Human papillomavirus detection in urine samples from male patients by the polymerase chain reaction. J. Clin. Microbiol. 27: 1711-1714.
19. Mosley, J. W. and J. Rakela. 1999. Foundling viruses and transfusion medicine. Transfusion 39: 1041-1044.
20. Oshima, K. H., T. T. Evans-strickfaden, and A. K. Highsmith. 1998. Comparison of filtration properties of hepatitis B virus, hepatitis C virus and simian virus 40 using a polyvinylidene fluoride membrane filter. Vox Sang. 75: 181-188.
21. Oshima, K. H., T. T. Evans-strickfaden, A. K. Highsmith, and E. W. Ades. 1998. The use of a microporus polyvinylidene fluoride (PVDF) membrane filter to separate contaminating viral particles from biologically important proteins. Biologicals 24: 137-145.
22. Prowse, C., C. A. Ludlam, and P. L. Yap. 1997. Human parvovirus B19 and blood products. Vox Sang. 72: 1-10.
23. Roberts, P. 1996. Virus safety of plasma products. Rev. Med. Virol. 6: 25-38.
24. Roberts, P. 1997. Efficient removal of viruses by a novel polyvinylidene fluoride membrane filter. J. Virol. Methods 65: 27-31.
25. Schalasta, G., M. Eggers, M. Schmid, and G. Enders. 2000. Analysis of human cytomegalovirus DNA in urines of newborns and infants by means of a new ultrarapid real-time PCR-system. J. Clin. Virol. 19: 175-185.
26. Sherry, S. 1987. Thrombolytic therapy in acute myocardial infarction. A perspective. Drugs 33(Suppl 3): 1-12.
27. Troccoli, N., J. Mclver, A. Losikoff, and J. Poiley. 1998. Removal of viruses from human intravenous immune globulin by 35 nm nanofiltration. Biologicals 26: 321-329.
28. Yoon, S. J., M. A. Yu, G. S. Sim, S. T. Kwon, J. K. Hwang, J. K. Shin, I. K. Yeo, and Y. R. Pyun. 2002. Screening and characterization of microorganisms with fibrinolytic activity from fermented foods. J. Microbiol. Biotechnol. 12: 649-656.