- Volume 51 Issue 3
DOI QR Code
TaqMan probe real-time PCR for quantitative detection of bovine adenovirus type 1 during the manufacture of biologics and medical devices using bovine-derived raw materials
소유래 성분 원재료 사용 생물의약품과 의료기기 제조 공정에서 bovine adenovirus type 1 정량 검출을 위한 TaqMan probe real-time PCR
- Ko, Woon Young (Center for Biopharmaceuticals Safety Validation, BioPS Co., Ltd. Daedeuk Valley Campus, Hannam University) ;
- Noh, Na Gyeong (Department of Biological Sciences and Biotechnology, Hannam University) ;
- Kim, In Seop (Department of Biological Sciences and Biotechnology, Hannam University)
- Received : 2015.08.19
- Accepted : 2015.09.11
- Published : 2015.09.30
Biologics and medical devices manufactured with bovine-derived raw materials have the risk of viral contamination. Therefore, viral validation study is essential to ensure the safety of the products. Bovine adenovirus type-1 (BAdV-1) is one of the common bovine viral pathogens. For quantitative detection of BAdV-1 during the manufacture of biologics and medical devices, a TaqMan probe real-time PCR method was developed. Specific primers and TaqMan probe for amplifying and detecting BAdV-1 DNA were designed. Specificity, limit of detection (LOD), and robustness of the method was validated according to international guideline on the validation of nucleic acid amplification tests for the pathogen detection. The sensitivity of the assay was found to be
biologics;bovine adenovirus;medical device;TaqMan probe real-time PCR;virus detection
Supported by : 한국연구재단
- Buckwalter, S.P., Sloan, L.M., Cunningham, S.A., Espy, M.J., Uhl, J.R., Jones, M.F., Vetter, E.A., Mandrekar, J., Cockerill III, F.R., Pritt, B.S., et al. 2014. Inhibition controls for qualitative real-time PCR assays: are they necessary for all specimen matrices?. J. Clin. Microbiol. 52, 2139-2143. https://doi.org/10.1128/JCM.03389-13
- Benko, M., Harrach, B., and Russell, W.C. 2000. Family Adenoviridae, pp. 227-238. In Van Regenmortel, M.H.V., Fauquet, C.M., Bishop, D.H.L., Carstens, E.B., Estes, M.K., Lemon, S.M., Maniloff, J., Mayo, M.A., McGeoch, D.J., Pringle, C.R., and Wickner, R.B. (eds.), Virus Taxonomy. Seventh Report of the International Committee on Taxonomy of Viruses. Academic Press, New York, San Diego, USA.
- Brennan, F.R., Baumann, A., Blaich, G., de Haan, L., Fagg, H., Kiessing, A., Kronenberg, S., Locher, M., Milton, M., Tibbitis, J., et al. 2015. Nonclinical safety testing of biopharmaceuticals - Addressing current challenges of these novel and emerging therapies. Regul. Toxicol. Pharmacol. 73, 265-275. https://doi.org/10.1016/j.yrtph.2015.07.019
- Celis, P. and Silvester, G. 2004. European regulatory guidance on virus safety of recombinant proteins, monoclonal antibodies and plasma derived medicinal products. Dev. Biol. Stand. 118, 3-10.
- Cho, H.M., Lee, D.H., Kim, H.M., and Kim, I.S. 2008. Real-time RT-PCR for quantitative detection of bovine viral diarrhoea virus during manufacture of biologics. Kor. J. Microbiol. Biotechnol. 36, 34-42.
- de Motes, C.M., Clemente-Casares, P., Hundesa, A., Martín, M., and Girones, R. 2004. Detection of bovine and porcine adenoviruses for tracing the source of fecal contamination. Appl. Environ. Microbiol. 70, 1448-1454. https://doi.org/10.1128/AEM.70.3.1448-1454.2004
- Delgado, L.M., Bayon, Y., Pandit, A., and Zeugolis, D.I. 2015. To cross-link or not to cross-link? Cross-linking associated foreign body response of collagen-based devices. Tissue Engin. Part B Rev. 21, 298-313. https://doi.org/10.1089/ten.teb.2014.0290
- Erickson, G.A., Bolin, S.R., and Landgraf, J.G. 1991. Viral contamination of fetal bovine serum used for tissue culture: risks and concerns. Dev. Biol. Stand. 75, 173-175.
- Hawkes, P.W. 2015 Fetal bovine serum: geographic origin and regulatory relevance of viral contamination. Bioresour. Bioprocess. 2, 34. https://doi.org/10.1186/s40643-015-0063-7
- Horaud, F. 1991. Introductory remark: viral safety of biologicals. Dev. Biol. Stand. 75, 3-7.
- ICH Expert Working Group. 1998. International conference on harmonization; guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin; availability. Fed. Resist. 63, 51074-51084.
- Ill, C.R. and Dehghani, H. 2009. Risk reduction in biotherapeutic products. Curr. Opin. Drug. Discov. Devel. 12, 296-304.
- Korea Food and Drug Administration. 2003. Guidance on the validation of nucleic acid amplification tests.
- Lee, D.H., Cho, H.M., Kim, H.M., Lee, J., and Kim, I.S. 2008a. 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.
- Lee, D.H., Jeong, H.S., Kim, T.E., Oh, S.H., Lee, J.S., and Kim, I.S. 2008b. Real-Time RT-PCR for validation of reovirus type 3 safety during the manufacture of mammalian cell culturederived biopharmaceuticals. Kor. J. Microbiol. 44, 228-236.
- Lee, D.H., Jeong, H.S., Lee, J.H., Kim, T.E., Lee, J., and Kim, I.S. 2008c. Real-time PCR for quantitative detection of bovine herpesvirus type 1. Kor. J. Microbiol. 44, 14-21.
- Lee, D.H., Lee, J.H., Kim, C.K., Kim, T.E., Bae, J.E., and Kim, I.S. 2008d. Real-time RT-PCR for quantitative detection of bovine parvovirus during manufacture of biologics. Kor. J. Microbiol. Biotechnol. 36, 173-181.
- Lee, J.I. and Kim, I.S. 2014. TaqMan probe real-time PCR for quantitative detection of mycoplasma during manufacture of biologics. Kor. Soc. Biotechnol. Bioeng. 29, 361-371.
- Lim, J.O. 2015. Regulation policy on cell- and tissue-based therapy products in Korea. Tissue Eng. Part A (Article in press)
- Marcus-Sekura, C., Richardson, J.C., Harston, R.K., Sane, N., and Sheets, R.L. 2011. Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products. Biologicals 39, 359-369. https://doi.org/10.1016/j.biologicals.2011.08.003
- Merten, O.W. 2002. Virus contamination of cell cultures-a biotechnological view. Cytotechnol. 39, 91-116. https://doi.org/10.1023/A:1022969101804
- Moon, J.W., Sohn, D.S., Heo, J.U., and Kim, J.S. 2015. Comparison of two kinds of bovine bone in maxillary sinus augmentation: a histomorphometric study. Implant Dent. 24, 19-24. https://doi.org/10.1097/ID.0000000000000187
- Motitschke, A., Ottiger, H.P., and Jungback, C. 2010. Evaluation of the sensitivity of PCR methods for the detection of extraneous agents and comparison with in vivo testing. Biologicals 38, 389-392. https://doi.org/10.1016/j.biologicals.2010.01.002
- Nims, R.W. 2006. Detection of adventitious viruses in biologicals-a rare occurrence. Dev. Biol. 123, 153-164.
- Oh, S.H., Bae, J.E., and Kim, I.S. 2012. Multiplex reverse transcription-PCR for simultaneous detection of reovirus, bovine viral diarrhea virus, and bovine parainfluenza virus during the manufacture of cell culture-derived biopharmaceuticals. Kor. J. Microbiol. Biotechnol. 40, 339-347. https://doi.org/10.4014/kjmb.1210.10008
- Parkman, P.D. 1996. Safety of biopharmaceuticals: a current perspective. Dev. Biol. Stand. 88, 5-7.
- Schiff, L.J. 2005. Review: production, characterization, and testing of banked mammalian cell substrates used to produce biological products. In Vitro Cell Dev. Biol. Anim. 41, 65-70. https://doi.org/10.1290/0503024.1
- Vaegler, M., Daum, L., Maurer, S., Stenzl, A., Busch, S., and Sievert, K.D. 2015. A bovine collagen type I-based biodegradable matrix as a carrier for tissue-engineered urothelium. J. Stem Cell Res. Ther. 5, 275.
- Wong, K. and Xagoraraki, I. 2010. Quantitative PCR assays to survey the bovine adenovirus levels in environmental samples. J. Appl. Micobiol. 109, 605-612.