Evaluation of viral inactivation efficacy of a continuous flow ultraviolet-C reactor (UVivatec)

Korean Journal of Microbiology and Biotechnology

Volumn 37, Issue 4, 2009, Pages 377-382

  Bae, Jung Eun ^a   Jeong, Eun Kyo ^a   Lee, Jae Il ^a   Lee, Jeong Im ^a   Kim, In Seop ^a   Kim, Jong Su ^b  

^a Hannam University   (South Korea)

^b CHA University   (South Korea)

Author keywords

Biopharmaceuticals; Log reduction factor; UVC irradiation; UVivatec; Virus inactivation

Indexed keywords

ARTICLE; BOCAVIRUS; BOVINE DIARRHEA VIRUS; BOVINE HERPES VIRUS; CONTINUOUS FLOW ULTRAVIOLET C REACTOR; CONTROLLED STUDY; HEPATITIS A VIRUS; HUMAN IMMUNODEFICIENCY VIRUS; MAMMALIAN ORTHOREOVIRUS; NONHUMAN; PARAINFLUENZA VIRUS 3; PARVOVIRUS; PORCINE PARVOVIRUS; RADIATION DOSE; RADIATION EXPOSURE; REACTOR; ULTRAVIOLET C RADIATION; ULTRAVIOLET RADIATION; VIRUS INACTIVATION;

ANIMALIA; BOVINAE; BOVINE PARAINFLUENZA VIRUS 3; BOVINE PARVOVIRUS; BOVINE VIRAL DIARRHEA VIRUS 1; HEPATITIS A VIRUS; HERPESVIRIDAE; HUMAN IMMUNODEFICIENCY VIRUS; MAMMALIAN ORTHOREOVIRUS 3; MINUTE VIRUS OF MICE; PORCINE PARVOVIRUS;

EID: 75649109719     PISSN: 1598642X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (27)

1. Adamson, S. R. 1999. Experiences of virus, retrovirus and retrovirus-like particles in Chinese hamster ovary (CHO) and hybridoma cells used for production of protein therapeutics. Dev. Biol. Stand. 93: 89-96.
2. Boschetti, N., I. Niederhauser, C. Kempf, A. Stuhler, J. Lower, and J. Blumel. 2004. Different susceptibility of B19 virus and mice minute virus to low pH treatment Transfusion 44: 1079-1086.
3. Chin, S. 1997. Virucidal treatment of blood protein products with UVC radiation. Photochem. Photobiol. 65: 423-435.
4. Choi, Y. W and I. S. Kim. 2008. Viral clearance during the manufacture of urokinase from human urine. Biotechnol. Bioprocess Eng. 13: 25-32.
5. Chudy, M., I. Budek, B. Keller-Stanislawski, K. A. McCaust-land, S. Neidhold, B. H. Robertson, C. M. Nubling, R. Seitz, and J. Lower. 1999. A new cluster of hepatitis A infection in hemophiliacs traced to a contaminated plasma pool. J. Med. Virol. 57: 91-99.
6. Committee for Proprietary Medicinal Products (CPMP), The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit. 1996. Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses (CPMP/BWP/268/95).
7. Garnick, R. L. 1996. Experience with viral contamination in cell culture. Dev. Biol. Stand. 88: 49-56.
8. Guertler, L. G. 2002. Virus safety of human blood, plasma, and derived products. Thromb. Res. 107: S39-S45.
9. Hart, H., K. Reid, and W. Hart. 1993. Inactivation of viruses during ultraviolet light treatment of human intravenous immunoglobulin and albumin. Vox Sang. 64: 82-88.
10. International Conference on Harmonisation. 1998. Guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability. Federal Resister 63: 51074-51084.
11. IL Kärber, J. 1931. Beitrag zur kollectiven Behandlung pharma-kologische Reihenversuche. Arch. Exp. Path. Pharmak. 162: 480-483.
12. Kim, I. S., Y. W. Choi, Y. Kang, H. M. Sung, and J. S. Shin. 2008. Dry-heat treatment process for enhancing viral safety of an antihemophilic factor VIII concentrate prepared from human plasma. J. Microbiol. Biotechnol. 18: 997-1003.
13. Kim, I .S., Y. W Choi, Y. Kang, H. M. Sung, K. W. Sohn, and Y-S. Kim. 2008. Improvement of virus safety of an anti-hemophilic factor IX by virus filtration process. J. Microbiol. Biotechnol. 18: 1317-1325.
14. Kleim, J. P., E. Bailly, K. E. Schneweis, H. H. Brackmann, U. Hammerstein, and P. Hanfland. 1990. Acute HIV-1 infection in patients with hemophilia treated with beta-propiolactone-UV-inactivated clotting factor. Thromb. Haemost. 64: 336-337.
15. Kupfer, B., J. Oldenburg, H. H. Brackmann, B. Matz, K. E. Schneweis, and R. Kaiser. 1995. Beta-propiolactone UV inactivated clotting factor concentrate is the source of HIV-infection of 8 hemophilia B patients: confirmed. Thromb. Haemost. 74: 1386-1387.
16. Laub, R. and P. Strengers. 2002. Parvovirus and blood products. Pathol. Biol. (Paris) b: 339-348.
17. Lawlor, E., S. Graham, E. Davidson, P. L. Yap, C. Cunningham, H. Daly, and I. J. Temperley. 1996. Hepatitis A transmission by factor IX concentrates. Vox Sang. 73: 189-190.
18. Lee, D. H., H. M. Cho, H. M. Kim, J. Lee, and I. S. Jim. 2008. Real-time PCR for validation of minute virus of mice safety during the manufacture of mammalian cell culture-derived biopharmaceuticals. Kor. J. Microbiol. Biotechnol. 36: 12-20.
19. Merten, O.-W. 2002. Virus contaminations of cell cultures - A biotechnological view. Cytotechnology 39: 91-116.
20. Murray, R., J. W Oliphant, J. T. Tripp, B. Hampil, F. Ratner, and W. C. L. Diefenbach. 1955. Effect of ultraviolet radiation on the infectivity of icterogenic plasma J. Am. Med. Assoc. 157: 8-14.
21. Robinson, S. M., H. Schwinn, and A. Smith. 1992. Clotting factors and hepatitis A. Lancet 340: 1465.
22. Rosenthal, N., F. A. Bassen, and S. R. Michael. 1950. Probable transmission of viral hepatitis by ultraviolet-irradiated plasma: report of three cases. J. Am. Med. Assoc. 144: 224-226.
23. Schmidt, S., J. Mora, S. Dolan, and J. Kauling. 2005. An integrated concept for robust and efficient virus clearance and contamination removal in biotech process. BioProcess Int. 3(September): 26-31.
24. Shin, J. S., Y. W. Choi, H. M. Sung, Y.-W Ryu, and I. S. Kim. 2006. Enhanced virus safety of a solvent/detergent-treated antihemophilic factor IX concentrate by dry-heat treatment. Biotech. Bioprocess Eng. 11: 19-25.
25. Wang, A. M., S.-F. Chao, K. Remington, R. Treckmann, K. Kaiser, D. Pifat, and J. Hotta. 2004. Virus inactivation and protein recovery in a novel ultraviolet-C reactor. Vox Sang. 86: 230-238.
26. Wang, S., C. Zinderman, R. Wise, and M. Braun. 2007. Infections and human tissue transplants: review of FDA MedWatch reports 2001-2004. Cell Tissue Banking 8: 211-219.
27. Wolf, A., J. Mason, W. J. Fitzpatrick, S. O. Schwartz, and S. O. Levinson. 1947. Ultraviolet irradiation of human plasma to control homologous serum jaundice. J. Am. Med. Assoc. 135: 476-477.