Real-Time PCR for Validation of Minute Virus of Mice Safety during the Manufacture of Mammalian Cell Culture-Derived Biopharmaceuticals |
Lee, Dong-Hyuck
(Department of Biological Sciences, Hannam University)
Cho, Hang-Mee (Department of Biological Sciences, Hannam University) Kim, Hyun-Mi (Department of Biological Sciences, Hannam University) Lee, Jung-Suk (Tissue Engineering Division, Research and Development Dept., Hans Daedeok R&D Center, Hans Biomed Corp.) Kim, In-Seop (Department of Biological Sciences, Hannam University) |
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 | Jeong, H.-S., J,-H. Shin, Y.-N. Park, J.-Y. Choi, Y.-L. Kim, B.-G. Kim, S.-R. Ryu, S.-Y. Baek, S.-H. Lee, and S.-N. Park. 2003. Development of real-time RT-PCR for evaluation of JEV clearance during purification of HPV type 16 L1 viruslike particles. Biologicals 31: 223-229 DOI ScienceOn |
3 | Kim, S. H and G. M. Lee. 2007. Differences in optimal pH and temperature for cell growth and antibody production between two Chinese hamster ovary clones derived from the same parental clone. J. Microbiol. Biotechnol. 17: 712-720 과학기술학회마을 |
4 | Park, S., J. Lee, B. Lee, and H. Kang. 2006. Production of humanised anti-hepatitis B antibody in butyrate-treated chinese hamster ovary cells. Kor. J. Microbiol. Biotechnol. 34: 47-51 과학기술학회마을 |
5 | Parkman, P. D. 1996. Safety of biopharmaceuticals: a current perspective. Dev. Biol. Stand. 88: 5-7 PUBMED |
6 | Shin, J. S., Y. W. Choi, H. M. Sung, Y.-W. Ryu, and I. S. Kim. 2006. Enhanced virus safety of a solvent/detergenttreated antihemophilic factor IX concentrate by dryheattreatment. Biotechnol. Bioprocess Eng. 11: 19-25 과학기술학회마을 DOI ScienceOn |
7 | Kraft, V. and B. Meyer. 1986. Diagnosis of murine infections in relation to test methods employed. Lab. Anim. Sci. 36: 271-276 PUBMED |
8 | Ryu, S.-R., J.-H. Shin, S.-Y. Baek, J.-O. Kim, K.-I. Min, B.- S. Min, B.-G. Kim, D.-K. Kim, M.-K. Park, M.-J. Ahn, K.- S. Chae, H.-S. Jeong, S.-H. Lee, and S.-N. Park. 2003 Evaluation of limit of detection and range of quantitation for RT-PCR, real-time RT-PCR and RT-PCR-ELISA detection of bovine viral diarrhea virus contamination in biologics derived from cell cultures. J. Bacteriol. Virol. 33: 161-168 |
9 | Cotmore, S. F. and P. Tattersall. 1987. The autonomously replicating parvoviruses of vertebrates. Adv. Virus Res. 33: 91-174 DOI |
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 | Chang, A., S. Havas, F. Borellini, J. M. Ostrove, and R. E. Bird. 1997. A rapid and simple procedure to detect the presence of MVM in conditioned cell fluids or culture media. Biologicals 25: 415-419 DOI ScienceOn |
12 | Kilham, L. and G. Margolis. 1971. Fetal infections of hamsters, rats, and mice induced with the minute virus of mice (MVM). Teratology 4: 43-61 DOI ScienceOn |
13 | Kilham, L. and G. Margolis. 1970. Pathogenicity of minute virus of mice (MVM) for rats, mice, and hamsters. Proc. Soc. Exp. Biol. Med. 133: 1447-1452 |
14 | Darling, A. 2002. Validation of biopharmaceutical purification process for virus clearance evaluation. Mol. Biotechnol. 21: 57-83 DOI ScienceOn |
15 | Garnick, R. L. 1998. Raw materials as a source of contamination in large-scale cell culture. Dev. Biol. Stand. 93: 21-29 PUBMED |
16 | Kajioka, J., R. Taguchi, and D. Nagaki. 1974. Plaque formation and replication of minute virus of mice. Kitasato Arch. Exp. Med. 47: 101-105 PUBMED |
17 | Zhan, D., M. R. Roy, C. Valera, J. Cardenas, J. C. Vennari, J. W. Che, and S. Liu. 2002. Detection of miute virus of mice using real time Quantitative PCR in assessment of virus clearance during the purification of mammalian cell substrate derived biotherapeutics. Biologicals 30: 259-270 DOI ScienceOn |
18 | Garnick, R. L. 1996. Experience with viral contamination in cell culture. Dev. Biol. Stand. 88: 49-56 PUBMED |
19 | Arden, N. and M. J. Betenbaugh. 2004. Life and death in mammalian cell culture: strategies for apoptosis inhibition. Trends Biotechnol. 22: 174-180. DOI ScienceOn |
20 | Celis, P. and G. Silvester. 2004. European regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products. Dev. Biol. Stand. 118: 3-10 |
21 | Kil, T. G., W. J. Kim, D. H. Lee, Y. Kang, H. M. Sung, S. H. Yoo, S.-N. Park, and I. S. Kim. 2005. Quantitative real-time PCR of porcine parvovirus as a model virus for cleaning validation of chromatography during manufacture of plasma derivatives. Kor. J. Microbiol. 41: 216-224 과학기술학회마을 |
22 | Parker, J. C., S. S. Cross, M. J. Collins Jr, and W. P. Rowe. 1970. Minute virus of mice : procedures for quantification and detection. J. Natl. Cancer Inst. 45: 2973-303 |
23 | Merten, O.-W. 2002. Virus contamination of cell cultures-a biotechnological view. Cytotechnol. 39: 91-116 DOI ScienceOn |
24 | Walsh, G. 2002. Proteins: Biochemistry and Biotechnology, pp. 196-209. John Wiley & Sons Ltd, Baffins Lane, Chichester, West Sussex, England |
25 | Horaud, F. 1991. Introductory remark: viral safety of biologicals. Dev. Biol. Stand. 75: 3-7 PUBMED |
26 | Boschetti, N., K. Wyss, A. Mischler, T. Hostettler, and C. Kempf. 2003. Stability of minute virus of mice against temperature and sodium hydroxide. Biologicals 31: 181-185 DOI ScienceOn |
27 | Nicklas, W., V. Kraft, and B. Meyer. 1993. Contamination of transplantable tumors, cell lines, and monoclonal antibodies with rodent viruses. Lab. Anim. Sci. 43: 296-300 PUBMED |
28 | Joung, J., S. Lee, S. Chang, J. Jeong, and Y. Sohn. Study for detection of adventious minute virus of mice from cell culture. Lab. Ani. Res. 21: 74-79 |