Quantitative Real-Time PCR of Porcine Parvovirus as a Model Virus for Cleaning Validation of Chromatography during Manufacture of Plasma Derivatives |
Kil Tae Gun
(Department of Biological Sciences, Hannam University)
Kim Won Jung (Department of Biological Sciences, Hannam University) Lee Dong Hyuk (Department of Biological Sciences, Hannam University) Kang Yong (Central Research Center, Green Cross Co.) Sung Hark Mo (Central Research Center, Green Cross Co.) Yoo Si Hyung (Blood Products Division, Biologics Evaluation Department Korea Food and Drug Administration) Park Sue-Nie (Blood Products Division, Biologics Evaluation Department Korea Food and Drug Administration) Kim In Seop (Department of Biological Sciences, Hannam University) |
1 | Willkommen, H., I. Schmidt, and J. Lower. 1999. Safety issues for plasma derivatives and benefit from NAT testing. Biologicals 27, 325-331 DOI ScienceOn |
2 | 김인섭. 2003. 바이러스 불활화 공정에 대한 hepatitis A virus와 murine encephalomyocarditis virus의 민감도 비교. 미생물학회지 39, 242-247 |
3 | Darling, A. 2002. Validation of biopharmaceutical purification process for virus clearance evaluation. Mol. Biotechnol. 21, 57-83 DOI ScienceOn |
4 | Horaud, F. 1991. Introductory remark: viral safety of biologicals. Dev. Biol. Stand. 75, 3-7 PUBMED |
5 | 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 virus-like particles. Biologicals 31, 223-229 DOI ScienceOn |
6 | Morrica, A., C. Nardini, A. Falbo, A. C. Bailey, and E. Bucci. 2003. Manufacturing process of Anti-thrombin III concentrate: viral safety validation studies and effect of column re-use on viral clearance. Biologicals 31, 1-9 DOI ScienceOn |
7 | Mosley, J.W. and J. Rakela. 1999. Foundling viruses and transfusion medicine. Transfusion 39, 1041-1044 DOI ScienceOn |
8 | Prowse, C., C.A. Ludlam, and P.L. Yap. 1997. Human parvovirus B19 and blood products. Vox Sang. 72, 1-10 DOI ScienceOn |
9 | Saldanha, J. 2001. Validation and standardisation of nucleic acid amplification technology (NAT) assays for the detection of viral contamination of blood and blood products. J. Clin. Virol. 20, 7-13 DOI ScienceOn |
10 | Kim, J. and C. Chae. 2003. Multiplex nested PCR compared with in situ hybridization for the differentiation of porcine circoviruses and porcine parvovirus from pigs with postweaning multisystematic wasting syndrome. Can. J. Vet. Res. 67, 133-137 |
11 | Boschetti, N. and A. Johnston. 2005. Virus elimination and validation. Methods Mol. Biol. 308, 209-220 |
12 | Kim, J., D.U. Han, C. Choi, and C. Chae. 2003. Simultaneous detection and differentiation between porcine circovirus and porcine parvovirus in boar semen by multiplex seminested polymerase chain reaction. J. Vet. Med. Sci. 65, 741-744 DOI ScienceOn |
13 | Schilt, U. 1989. Overview of viruses relevant to blood transfusion. Curr. Stud. Hematol. Blood Transf. 56, 1-8 |
14 | Horowitz, B. 1990. Blood protein derivative viral safety: observations and analysis. Yale J. Med. 63, 361-369 |
15 | The European Agency for the Evaluation of Medicinal Products: Human Medicines Evaluation Unit. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on plasma derived medicinal products (CPMP/BWP/269/95 rev2) |
16 | Burgoyne, R.F., M.C. Priest, K.L. Roche, and G. Vella. 1993. Systematic development and validation of sanitization protocols for a chromatography system designed for biotherapeutics purification. J. Pharm. Biomed. Anal. 11, 1317-1325 DOI ScienceOn |
17 | 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 |
18 | Arnauld, C., O. Legecy, Y. Laurian, R. Thiery, M. Denis, P. Blanchard, and A. Jestin. 1998. Development of a PCR-based method coupled with a microplate colorimetric assay for the detection of porcine parvovirus and application to diagnosis in piglet tissues and human plasma. Mol. Cell. Probes 12, 407-416 DOI ScienceOn |
19 | Roberts, P. 1996. Virus safety of plasma products. Rev. Med. Virol. 6, 25-38 DOI PUBMED ScienceOn |
20 | Active Pharmaceutical Ingredients Committee. 1999. Cleaning validation in active pharmaceutical ingredient manufacturing plants |
21 | 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 |
22 | Bronrson, K., J. Brown, E. Hamilton, and K.E. Stein. 2003. Identification of protein A media performance attributes that can be monitored as surrogates for retrovirus clearance during extended re-use. J. Chromatogr. A. 989, 155-163 DOI PUBMED ScienceOn |
23 | 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 |
24 | Kim, I.S., Y.W. Choi, S.R. Lee, Y. Kang, K.M. Lee, D.H. Park, H.S. Woo, and S. Lee. 2002. Removal and inactivation of hepatitis A virus during manufacture of urokinase from human urine. Biotechnol. Bioprocess Eng. 7, 340-346 DOI ScienceOn |
25 | Huang, C., J.-J. Hung, C.-Y. Wu, and M.-S. Chien. 2004. Multiplex PCR for rapid detection of pseudorabies virus, porcine parvovirus and porcine circoviruses. Vet. Microbiol. 101, 209-214 DOI ScienceOn |
26 | Parkman, P.D. 1996. Safety of biopharmaceuticals: a current perspective. Dev. Biol. Stand. 88, 5-7 PUBMED |
27 | Celis, P. and G. Silvester. 2004. European regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products. Dev. Biol. 118, 3-10 |
28 | Kleinman, S. 1999. Residual risk of transfusion transmitted viral infections among seronegative donors: application of the incidence/ window period model. Dev. Biol. Stand. 102, 61-65 |
29 | Cuthbertson, B., K.G. Reid, and P.R. Foster. 1991. Viral contamination of human plasma and procedures for preventing virus transmission by plasma products, p. 385-435. In J.R. Harris (ed.), Blood separation and plasma fractionation. Willey-Liss Inc., New York |
30 | Food and Drug Administration. 1993. Guide to inspection for validation of cleaning processes |
31 | Sofer, G. 2003. Current issues in validation of chromatography. Dev. Biol. 113, 61-64 |
32 | Sherwood, W.C. 1993. The significance of the blood-borne viruses: blood banking and transfusion medicine. Dev. Biol. Stand.81, 25-33 PUBMED |
33 | Farshid, M. 2004. Viral safety evaluation of plasma-derived therapeutic products. Dev. Biol. 118, 11-15 |