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Volumn 30, Issue 17, 2012, Pages 2715-2727

Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines

Author keywords

Cell bank characterisation; Cell substrates; Live attenuated virus vaccines; Oncogenicity; Regulations; Tumourigenicity

Indexed keywords

ALPHA INTERFERON; BETA INTERFERON; DIPLOID CELL VACCINE; LIVE VACCINE; MODIFIED VACCINIA VIRUS ANKARA 5T4 VACCINE; ROTAVIRUS VACCINE; VACCINE; VIRUS VACCINE;

EID: 84858700318     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2012.02.015     Document Type: Review
Times cited : (51)

References (114)
  • 1
    • 84858700826 scopus 로고    scopus 로고
    • Pandemic influenza vaccines: current status, pandemic (H1N1) 2009 briefing note 11; 24 September
    • Pandemic influenza vaccines: current status, pandemic (H1N1) 2009 briefing note 11; 24 September 2009. http://www.who.int/csr/disease/swineflu/notes/pandemic_influenza_vaccines_20090924/en/index.html.
    • (2009)
  • 2
    • 84858702955 scopus 로고    scopus 로고
    • Vaccines: preventive and therapeutic vaccines and adjuvants on the rise
    • Hess R.D., Ghosh P. Vaccines: preventive and therapeutic vaccines and adjuvants on the rise. J Clin Studies 2009, 40-43.
    • (2009) J Clin Studies , pp. 40-43
    • Hess, R.D.1    Ghosh, P.2
  • 4
    • 0001927825 scopus 로고
    • Clinical influenza virus and the embryonated hen's egg
    • Robertson J.S. Clinical influenza virus and the embryonated hen's egg. Rev Med Virol 1993, 3:97-106.
    • (1993) Rev Med Virol , vol.3 , pp. 97-106
    • Robertson, J.S.1
  • 7
    • 84858702756 scopus 로고    scopus 로고
    • USP-NF <1235> Vaccines for human use-general considerations.
    • USP-NF <1235> Vaccines for human use-general considerations.
  • 8
    • 84858702755 scopus 로고    scopus 로고
    • USP-NF <1237> Virology test methods.
    • USP-NF <1237> Virology test methods.
  • 9
    • 84858697794 scopus 로고    scopus 로고
    • USP-NF <1050> Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
    • USP-NF <1050> Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin.
  • 10
    • 84858700827 scopus 로고    scopus 로고
    • CBER 2001: United States of America, Food and Drug Administration Center for Biologics Evaluation and Research, Vaccines and related Biologicals Products Advisory Committee, Meeting Wednesday; May 16,
    • CBER 2001: United States of America, Food and Drug Administration Center for Biologics Evaluation and Research, Vaccines and related Biologicals Products Advisory Committee, Meeting Wednesday; May 16, 2001. http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf.
    • (2001)
  • 11
    • 33745344073 scopus 로고    scopus 로고
    • Development of novel E1-complementary cells for adenoviral production free of replication-competent adenovirus
    • Farson D., Tao L., Ko D., Li Q., Brignetti D., Segawa K., et al. Development of novel E1-complementary cells for adenoviral production free of replication-competent adenovirus. Mol Ther 2006, 14(2):305-311.
    • (2006) Mol Ther , vol.14 , Issue.2 , pp. 305-311
    • Farson, D.1    Tao, L.2    Ko, D.3    Li, Q.4    Brignetti, D.5    Segawa, K.6
  • 12
    • 84858697798 scopus 로고    scopus 로고
    • Guidance for industry: characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases. Draft Guidance US CBER; September
    • Guidance for industry: characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention and treatment of infectious diseases. Draft Guidance US CBER; September 2006. , . http://tinyurl.com/6h6xssk.
    • (2006)
  • 13
    • 84858706634 scopus 로고    scopus 로고
    • Guidance for industry: characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications; February
    • Guidance for industry: characterization and qualification of cell substrates and other biological materials used in the production of viral vaccines for infectious disease indications; February 2010. http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/vaccines/ucm202439.pdf.
    • (2010)
  • 15
    • 84858706633 scopus 로고    scopus 로고
    • EudraLex Good manufacturing practice (GMP) guidelines.
    • EudraLex-Volume 4, Good manufacturing practice (GMP) guidelines. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm.
    • , vol.1
  • 16
    • 84858697796 scopus 로고    scopus 로고
    • European Pharmacopoeia (EP) 01/2009:0153 Vaccines for human use.
    • European Pharmacopoeia (EP) 01/2009:0153 Vaccines for human use.
    • (2009)
  • 17
    • 84858706632 scopus 로고    scopus 로고
    • European Pharmacopoeia (EP) 5.1.7. Viral safety.
    • European Pharmacopoeia (EP) 5.1.7. Viral safety.
  • 18
    • 84858697795 scopus 로고    scopus 로고
    • European Pharmacopoeia (EP) 5.2.2. Chicken flocks free from specific pathogens for the production and quality control of vaccines.
    • European Pharmacopoeia (EP) 5.2.2. Chicken flocks free from specific pathogens for the production and quality control of vaccines.
  • 19
    • 84858700831 scopus 로고    scopus 로고
    • European Pharmacopoeia (EP) 5.2.3. Cell substrate for the production of vaccines for human use.
    • European Pharmacopoeia (EP) 5.2.3. Cell substrate for the production of vaccines for human use.
  • 20
    • 84858700828 scopus 로고    scopus 로고
    • European Pharmacopoeia (EP) 2.6.16. Tests for extraneous agents in viral vaccines for human use.
    • European Pharmacopoeia (EP) 2.6.16. Tests for extraneous agents in viral vaccines for human use.
  • 21
    • 84858706628 scopus 로고    scopus 로고
    • EMEA/CPMP/BWP/2289/01. Points to consider on the development of live attenuated influenza vaccines.
    • EMEA/CPMP/BWP/2289/01. Points to consider on the development of live attenuated influenza vaccines.
  • 22
    • 84858706629 scopus 로고    scopus 로고
    • CPMP/1100/02. Note for guidance for the development of vaccinia virus based vaccines against smallpox.
    • CPMP/1100/02. Note for guidance for the development of vaccinia virus based vaccines against smallpox.
  • 23
    • 84858706630 scopus 로고    scopus 로고
    • EMEA/CHMP/BWP/398498/2005-corr. Guideline on virus safety evaluation of biotechnological investigational medicinal products.
    • EMEA/CHMP/BWP/398498/2005-corr. Guideline on virus safety evaluation of biotechnological investigational medicinal products.
    • (2005)
  • 24
    • 84858700829 scopus 로고    scopus 로고
    • EMEA/CHMP/VWP/141697/2009. Draft guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines.
    • EMEA/CHMP/VWP/141697/2009. Draft guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines.
    • (2009)
  • 25
    • 84858700830 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R1).
    • ICH Harmonised Tripartite Guideline: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R1). http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.
  • 26
    • 84858706631 scopus 로고
    • ICH Harmonised Tripartite Guideline: quality of biotechnological products: analysis of the expression construct in cells used for production of r-DNA derived protein products, Guideline Q5B. Current Step 4 version; 30 November
    • ICH Harmonised Tripartite Guideline: quality of biotechnological products: analysis of the expression construct in cells used for production of r-DNA derived protein products, Guideline Q5B. Current Step 4 version; 30 November 1995. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.
    • (1995)
  • 27
    • 84858702754 scopus 로고    scopus 로고
    • ICH Harmonised Tripartite Guideline: derivation and characterization of cell substrates used for production of biotechnological/biological products Q5D. Current Step 4 version; 16 July
    • ICH Harmonised Tripartite Guideline: derivation and characterization of cell substrates used for production of biotechnological/biological products Q5D. Current Step 4 version; 16 July 1997. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html.
    • (1997)
  • 29
    • 41949119694 scopus 로고    scopus 로고
    • WHO Study Group on cell substrates for production of biologicals, Geneva, Switzerland, 11-12 June 2007
    • Knezevic I., Stacey G., Petricciani J. WHO Study Group on cell substrates for production of biologicals, Geneva, Switzerland, 11-12 June 2007. Biologicals 2008, 36:203-211.
    • (2008) Biologicals , vol.36 , pp. 203-211
    • Knezevic, I.1    Stacey, G.2    Petricciani, J.3
  • 31
    • 84858700825 scopus 로고    scopus 로고
    • Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Proposed replacement of TRS 878, Annex I.
    • Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. Proposed replacement of TRS 878, Annex I. http://www.who.int/biologicals/Cell_Substrates_clean_version_18_April.pdf.
  • 33
    • 84858702752 scopus 로고    scopus 로고
    • Technical report series: vaccines, .
    • Technical report series: vaccines, . http://tinyurl.com/6argpwl.
  • 34
    • 84858697792 scopus 로고    scopus 로고
    • EUDRALEX, guidelines for good manufacturing practice for medicinal products for human and veterinary use Draft Annex 2.
    • EUDRALEX, Volume 4EU guidelines for good manufacturing practice for medicinal products for human and veterinary use Draft Annex 2. http://ec.europa.eu/health/documents/latest_news/gmp_annex2_03-2010.pdf.
    • , vol.4 EU
  • 35
    • 0036657443 scopus 로고    scopus 로고
    • Good cell culture practice ECVAM good cell culture practice task force report 1
    • Hartung T., Balls M., Bardouille C., Blanck O., Coecke S., Gstraunthaler G., et al. Good cell culture practice ECVAM good cell culture practice task force report 1. ATLA 2002, 30:407-414.
    • (2002) ATLA , vol.30 , pp. 407-414
    • Hartung, T.1    Balls, M.2    Bardouille, C.3    Blanck, O.4    Coecke, S.5    Gstraunthaler, G.6
  • 36
    • 22044435932 scopus 로고    scopus 로고
    • Guidance on good cell culture practice, a report of the second ECVAM task force on good cell culture practice
    • Coecke S., Balls M., Bowe G., Davis J., Gstraunthaler G., Hartung T., et al. Guidance on good cell culture practice, a report of the second ECVAM task force on good cell culture practice. ATLA 2005, 33:261-287.
    • (2005) ATLA , vol.33 , pp. 261-287
    • Coecke, S.1    Balls, M.2    Bowe, G.3    Davis, J.4    Gstraunthaler, G.5    Hartung, T.6
  • 37
    • 84858702751 scopus 로고    scopus 로고
    • Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. WHO, Draft; 8 July
    • Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks. WHO, Draft; 8 July 2009. http://2009.ncnv.org/who.html.
    • (2009)
  • 38
    • 33644631842 scopus 로고    scopus 로고
    • Approaches to the release of a master cell bank of PER.C6 cells; a novel cell substrate for the manufacture of human vaccines
    • Lewis A.M., Brown E.L., Duncan P.A. Approaches to the release of a master cell bank of PER.C6 cells; a novel cell substrate for the manufacture of human vaccines. Dev Biol 2006, 123:165-176.
    • (2006) Dev Biol , vol.123 , pp. 165-176
    • Lewis, A.M.1    Brown, E.L.2    Duncan, P.A.3
  • 39
    • 33644622434 scopus 로고    scopus 로고
    • Tumourigenicity assessments of PER.C6 cells and of an Ad5-vectored HIV-1 vaccine produced on this continuous cell line
    • Ledwith B.J., Lanning C.L., Gumprecht L.A., Anderson C.A., Coleman J.B., Gatto N.T., et al. Tumourigenicity assessments of PER.C6 cells and of an Ad5-vectored HIV-1 vaccine produced on this continuous cell line. Dev Biol 2006, 123:251-263.
    • (2006) Dev Biol , vol.123 , pp. 251-263
    • Ledwith, B.J.1    Lanning, C.L.2    Gumprecht, L.A.3    Anderson, C.A.4    Coleman, J.B.5    Gatto, N.T.6
  • 40
    • 84858706625 scopus 로고    scopus 로고
    • Vaccines and related biological products advisory committee, meeting, May 16, on designer cells as substrates for the manufacture of viral vaccines.
    • Vaccines and related biological products advisory committee, meeting, May 16, 2001, on designer cells as substrates for the manufacture of viral vaccines. http://www.fda.gov/ohrms/dockets/ac/01/briefing/3750b1_01.htm.
    • (2001)
  • 41
    • 78149319046 scopus 로고    scopus 로고
    • The avian EB66(R) cell line, application to vaccines, and therapeutic protein production
    • Braun S.W., Mehtali M. The avian EB66(R) cell line, application to vaccines, and therapeutic protein production. PDA J Pharm Sci Technol 2010, 64(5):419-425.
    • (2010) PDA J Pharm Sci Technol , vol.64 , Issue.5 , pp. 419-425
    • Braun, S.W.1    Mehtali, M.2
  • 42
    • 58249123674 scopus 로고    scopus 로고
    • An avian cell line designed for production of highly attenuated viruses
    • Jordan I., Vos A., Beilfuss S., Neubert A., Breul S., Sandig V. An avian cell line designed for production of highly attenuated viruses. Vaccine 2009, 27(5):748-756.
    • (2009) Vaccine , vol.27 , Issue.5 , pp. 748-756
    • Jordan, I.1    Vos, A.2    Beilfuss, S.3    Neubert, A.4    Breul, S.5    Sandig, V.6
  • 43
    • 67650430190 scopus 로고    scopus 로고
    • New avian suspension cell lines provide production of influenza virus and MVA in serum-free media: studies on growth, metabolism and virus propagation
    • Lohr V., Rath A., Genzel Y., Jordan I., Sandig V., Reichl U. New avian suspension cell lines provide production of influenza virus and MVA in serum-free media: studies on growth, metabolism and virus propagation. Vaccine 2009, 6(27):4975-4982.
    • (2009) Vaccine , vol.6 , Issue.27 , pp. 4975-4982
    • Lohr, V.1    Rath, A.2    Genzel, Y.3    Jordan, I.4    Sandig, V.5    Reichl, U.6
  • 44
    • 84858697791 scopus 로고    scopus 로고
    • US Patent Application, No. 2010/0021499 A1, .
    • US Patent Application, No. 2010/0021499 A1, . http://ip.com/patapp/US20100021499.
  • 45
    • 0017710978 scopus 로고
    • Characteristics of a human cell line transformed by DNA from human adenovirus type 5
    • Graham F.L., Smiley J., Russell W.C., Nairn R. Characteristics of a human cell line transformed by DNA from human adenovirus type 5. J Gen Virol 1977, 36:59-74.
    • (1977) J Gen Virol , vol.36 , pp. 59-74
    • Graham, F.L.1    Smiley, J.2    Russell, W.C.3    Nairn, R.4
  • 46
    • 0035135747 scopus 로고    scopus 로고
    • Viral vectors for gene therapy: the art of turning infectious agents into vehicles of therapeutics
    • Kay M.A., Glorioso J.C., Naldini L. Viral vectors for gene therapy: the art of turning infectious agents into vehicles of therapeutics. Nat Med 2001, 7:33-40.
    • (2001) Nat Med , vol.7 , pp. 33-40
    • Kay, M.A.1    Glorioso, J.C.2    Naldini, L.3
  • 47
    • 0036903118 scopus 로고    scopus 로고
    • The oncolytic virotherapy treatment platform for cancer: unique biological and biosafety points to consider
    • Vile R., Ando D., Kirn D. The oncolytic virotherapy treatment platform for cancer: unique biological and biosafety points to consider. Cancer Gene Ther 2002, 9:1062-1067.
    • (2002) Cancer Gene Ther , vol.9 , pp. 1062-1067
    • Vile, R.1    Ando, D.2    Kirn, D.3
  • 48
    • 43949099690 scopus 로고    scopus 로고
    • Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults
    • Priddy F.H., Brown D., Kublin J., Monahan K., Wright D.P., Lalezari J., et al. Safety and immunogenicity of a replication-incompetent adenovirus type 5 HIV-1 clade B gag/pol/nef vaccine in healthy adults. Clin Infect Dis 2008, 46(11):1769-1781.
    • (2008) Clin Infect Dis , vol.46 , Issue.11 , pp. 1769-1781
    • Priddy, F.H.1    Brown, D.2    Kublin, J.3    Monahan, K.4    Wright, D.P.5    Lalezari, J.6
  • 49
    • 0035226167 scopus 로고    scopus 로고
    • A defined-risks approach to the regulatory assessment of the use of neoplastic cells as substrates for viral vaccine manufacturer
    • Lewis A.M. A defined-risks approach to the regulatory assessment of the use of neoplastic cells as substrates for viral vaccine manufacturer. Dev Biol 2001, 106:513-535.
    • (2001) Dev Biol , vol.106 , pp. 513-535
    • Lewis, A.M.1
  • 52
    • 84858706627 scopus 로고    scopus 로고
    • P53 in normal and neoplastic tissue: analysis and function
    • [review]
    • Hess R.D., Brandner G. p53 in normal and neoplastic tissue: analysis and function. EI J Pathol Histol 1996, 961-1007. [review].
    • (1996) EI J Pathol Histol , pp. 961-1007
    • Hess, R.D.1    Brandner, G.2
  • 53
    • 59349107940 scopus 로고    scopus 로고
    • The common mechanisms of transformation by the small DNA tumour viruses: the inactivation of tumour suppressor gene products: p53
    • Levine A.J. The common mechanisms of transformation by the small DNA tumour viruses: the inactivation of tumour suppressor gene products: p53. Virology 2009, 384:285-293.
    • (2009) Virology , vol.384 , pp. 285-293
    • Levine, A.J.1
  • 54
    • 33845810482 scopus 로고    scopus 로고
    • Adenovirus type 5 early region 1B 156R protein promotes cell transformation independently of repression of p53-stimulated transcription
    • Sieber T., Dobner T. Adenovirus type 5 early region 1B 156R protein promotes cell transformation independently of repression of p53-stimulated transcription. J Virol 2007, 81:95-105.
    • (2007) J Virol , vol.81 , pp. 95-105
    • Sieber, T.1    Dobner, T.2
  • 56
    • 0037227584 scopus 로고    scopus 로고
    • Evaluation of a genetically modified reassortant H5N1 influenza A virus vaccine candidate generated by plasmid-based reverse genetics
    • Subbarao K., Chen H., Swayne D., Mingay L., Fodor E., Brownlee G., et al. Evaluation of a genetically modified reassortant H5N1 influenza A virus vaccine candidate generated by plasmid-based reverse genetics. Virology 2003, 305:192-200.
    • (2003) Virology , vol.305 , pp. 192-200
    • Subbarao, K.1    Chen, H.2    Swayne, D.3    Mingay, L.4    Fodor, E.5    Brownlee, G.6
  • 57
    • 47349125949 scopus 로고    scopus 로고
    • Cell-based influenza vaccines: progress to date
    • Audsley J.M., Tannock G.A. Cell-based influenza vaccines: progress to date. Drugs 2008, 68:1483-1491.
    • (2008) Drugs , vol.68 , pp. 1483-1491
    • Audsley, J.M.1    Tannock, G.A.2
  • 58
    • 84858702753 scopus 로고    scopus 로고
    • Generation of live attenuated novel influenza A/California/7/09 (H1N1) vaccines with high yield in embryonated chicken eggs
    • [28 October, Epub ahead of print]
    • Chen Z., Wang W., Zhou H., Suguitan A.L., Shambaugh C., Kim L., et al. Generation of live attenuated novel influenza A/California/7/09 (H1N1) vaccines with high yield in embryonated chicken eggs. J Virol 2009, [28 October, Epub ahead of print].
    • (2009) J Virol
    • Chen, Z.1    Wang, W.2    Zhou, H.3    Suguitan, A.L.4    Shambaugh, C.5    Kim, L.6
  • 59
    • 0034767753 scopus 로고    scopus 로고
    • Antiviral actions of interferons
    • Samuel C.E. Antiviral actions of interferons. Clin Microbiol Rev 2001, 14:778-809.
    • (2001) Clin Microbiol Rev , vol.14 , pp. 778-809
    • Samuel, C.E.1
  • 60
    • 33646752347 scopus 로고    scopus 로고
    • Differentially regulated interferon response determines the outcome of Newcastle disease virus infection in normal and tumor cell lines
    • Krishnamurthy S., Takimoto T., Scroggs R.A., Portner A. Differentially regulated interferon response determines the outcome of Newcastle disease virus infection in normal and tumor cell lines. J Virol 2006, 80:5145-5155.
    • (2006) J Virol , vol.80 , pp. 5145-5155
    • Krishnamurthy, S.1    Takimoto, T.2    Scroggs, R.A.3    Portner, A.4
  • 61
    • 0033929057 scopus 로고    scopus 로고
    • Exploiting tumor-specific defects in the interferon pathway with a previously unknown oncolytic virus
    • Stojdl D.F., Lichty B., Knowles S., Marius R., Atkins H., Sonenberg N., et al. Exploiting tumor-specific defects in the interferon pathway with a previously unknown oncolytic virus. Nat Med 2000, 6:821-825.
    • (2000) Nat Med , vol.6 , pp. 821-825
    • Stojdl, D.F.1    Lichty, B.2    Knowles, S.3    Marius, R.4    Atkins, H.5    Sonenberg, N.6
  • 62
    • 33646167291 scopus 로고    scopus 로고
    • Negative regulation of the alpha interferon-induced antiviral response by the Ras/Raf/MEK pathway
    • Battcock S.M., Collier T.W., Zu D., Hirasawa K. Negative regulation of the alpha interferon-induced antiviral response by the Ras/Raf/MEK pathway. J Virol 2006, 80:4422-4430.
    • (2006) J Virol , vol.80 , pp. 4422-4430
    • Battcock, S.M.1    Collier, T.W.2    Zu, D.3    Hirasawa, K.4
  • 63
    • 0026481080 scopus 로고
    • Oncogenic ras induces an inhibitor of double-stranded RNA-dependent eukaryotic initiation factor 2 alpha-kinase activation
    • Mundschau L.J., Faller D.V. Oncogenic ras induces an inhibitor of double-stranded RNA-dependent eukaryotic initiation factor 2 alpha-kinase activation. J Biol Chem 1992, 267:23092-23098.
    • (1992) J Biol Chem , vol.267 , pp. 23092-23098
    • Mundschau, L.J.1    Faller, D.V.2
  • 64
    • 0032526693 scopus 로고    scopus 로고
    • The molecular basis of viral oncolysis: usurpation of the Ras signaling pathway by reovirus
    • Strong J.E., Coffey M.C., Tang D., Sabinin P., Lee P.W. The molecular basis of viral oncolysis: usurpation of the Ras signaling pathway by reovirus. J EMBO 1998, 17:3351-3362.
    • (1998) J EMBO , vol.17 , pp. 3351-3362
    • Strong, J.E.1    Coffey, M.C.2    Tang, D.3    Sabinin, P.4    Lee, P.W.5
  • 65
    • 1642553650 scopus 로고    scopus 로고
    • Defective translational control facilitates vesicularstomatitis virus oncolysis
    • Balachandran S., Barber G.N. Defective translational control facilitates vesicularstomatitis virus oncolysis. Cancer Cell 2004, 5:51-65.
    • (2004) Cancer Cell , vol.5 , pp. 51-65
    • Balachandran, S.1    Barber, G.N.2
  • 66
    • 0032515141 scopus 로고    scopus 로고
    • Reovirus therapy of tumors with activated Ras pathway
    • Coffey M.C., Strong J.E., Forsyth P.A., Lee P.W. Reovirus therapy of tumors with activated Ras pathway. Science 1998, 282:1332-1334.
    • (1998) Science , vol.282 , pp. 1332-1334
    • Coffey, M.C.1    Strong, J.E.2    Forsyth, P.A.3    Lee, P.W.4
  • 67
    • 0024368324 scopus 로고
    • Polio and rabies vaccines produced in continuous cell lines: a reality for Vero cell line
    • Montagnon B.J. Polio and rabies vaccines produced in continuous cell lines: a reality for Vero cell line. Dev Biol Stand 1989, 70:27-47.
    • (1989) Dev Biol Stand , vol.70 , pp. 27-47
    • Montagnon, B.J.1
  • 68
    • 65649125562 scopus 로고    scopus 로고
    • Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines
    • Barrett P.N., Mundt W., Kistner O., Howard M.K. Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines. Expert Rev Vaccines 2009, 8:607-618.
    • (2009) Expert Rev Vaccines , vol.8 , pp. 607-618
    • Barrett, P.N.1    Mundt, W.2    Kistner, O.3    Howard, M.K.4
  • 69
    • 0014340574 scopus 로고
    • Defectiveness of interferon production and of rubella virus interference in a line of African green monkey kidney cells (Vero)
    • Desmyter J., Melnick J.L., Rawls W.E. Defectiveness of interferon production and of rubella virus interference in a line of African green monkey kidney cells (Vero). J Virol 1968, 2:955-961.
    • (1968) J Virol , vol.2 , pp. 955-961
    • Desmyter, J.1    Melnick, J.L.2    Rawls, W.E.3
  • 70
    • 0018756890 scopus 로고
    • Regulation of the interferon system: evidence that Vero cells have a genetic defect in interferon production
    • Emeny J.M., Morgan M.J. Regulation of the interferon system: evidence that Vero cells have a genetic defect in interferon production. J Gen Virol 1979, 43:247-252.
    • (1979) J Gen Virol , vol.43 , pp. 247-252
    • Emeny, J.M.1    Morgan, M.J.2
  • 71
    • 0001122795 scopus 로고
    • Homozygous deletion of the alpha- and beta 1-interferon genes in human leukemia and derived cell lines
    • Diaz M.O., Ziemin S., Le Beau M.M., Pitha P., Smith S.D., Chilcote R.R., et al. Homozygous deletion of the alpha- and beta 1-interferon genes in human leukemia and derived cell lines. Proc Natl Acad Sci U S A 1988, 85:5259-5263.
    • (1988) Proc Natl Acad Sci U S A , vol.85 , pp. 5259-5263
    • Diaz, M.O.1    Ziemin, S.2    Le Beau, M.M.3    Pitha, P.4    Smith, S.D.5    Chilcote, R.R.6
  • 72
    • 0022725646 scopus 로고
    • Transcriptional and posttranscriptional regulation of exogenous human beta interferon gene in simian cells defective in interferon synthesis
    • Mosca J.D., Pitha P.M. Transcriptional and posttranscriptional regulation of exogenous human beta interferon gene in simian cells defective in interferon synthesis. Mol Cell Biol 1986, 6:2279-2283.
    • (1986) Mol Cell Biol , vol.6 , pp. 2279-2283
    • Mosca, J.D.1    Pitha, P.M.2
  • 73
    • 52649178760 scopus 로고    scopus 로고
    • T7 RNA polymerase-dependent and -independent systems for cDNA-based rescue of Rift Valley fever virus
    • Habjan M., Penski N., Spiegel M., Weber F. T7 RNA polymerase-dependent and -independent systems for cDNA-based rescue of Rift Valley fever virus. J Gen Virol 2008, 89:2157-2166.
    • (2008) J Gen Virol , vol.89 , pp. 2157-2166
    • Habjan, M.1    Penski, N.2    Spiegel, M.3    Weber, F.4
  • 74
    • 13944253573 scopus 로고    scopus 로고
    • Regulating intracellular antiviral defense and permissiveness to hepatitis C virus RNA replication through a cellular RNA helicase, RIG-I
    • Sumpter R., Loo Y.M., Foy E., Li K., Yoneyama M., Fujita T., et al. Regulating intracellular antiviral defense and permissiveness to hepatitis C virus RNA replication through a cellular RNA helicase, RIG-I. J Virol 2005, 79:2689-2699.
    • (2005) J Virol , vol.79 , pp. 2689-2699
    • Sumpter, R.1    Loo, Y.M.2    Foy, E.3    Li, K.4    Yoneyama, M.5    Fujita, T.6
  • 76
    • 36348940608 scopus 로고    scopus 로고
    • Interferons and viruses: an interplay between induction, signalling, antiviral responses and virus countermeasures
    • Randall R.E., Goodbourn S. Interferons and viruses: an interplay between induction, signalling, antiviral responses and virus countermeasures. J Gen Virol 2008, 89:1-47.
    • (2008) J Gen Virol , vol.89 , pp. 1-47
    • Randall, R.E.1    Goodbourn, S.2
  • 77
    • 77955413296 scopus 로고    scopus 로고
    • Viral tricks to grid-lock the type I interferon system
    • Versteeg G.A., Garcia-Sastre A. Viral tricks to grid-lock the type I interferon system. Curr Opin Microbiol 2010, 13:508-516.
    • (2010) Curr Opin Microbiol , vol.13 , pp. 508-516
    • Versteeg, G.A.1    Garcia-Sastre, A.2
  • 78
    • 34347227416 scopus 로고    scopus 로고
    • Viral suppression of the interferon system
    • Weber F., Haller O. Viral suppression of the interferon system. Biochimie 2007, 89(6-7):836-842.
    • (2007) Biochimie , vol.89 , Issue.6-7 , pp. 836-842
    • Weber, F.1    Haller, O.2
  • 79
    • 38449091907 scopus 로고    scopus 로고
    • Differential type I IFN-inducing abilities of wild-type versus vaccine strains of measles virus
    • Shingai M., Ebihara T., Begum N.A., Kato A., Honma T., Matsumoto K., et al. Differential type I IFN-inducing abilities of wild-type versus vaccine strains of measles virus. J Immunol 2007, 179:6123-6133.
    • (2007) J Immunol , vol.179 , pp. 6123-6133
    • Shingai, M.1    Ebihara, T.2    Begum, N.A.3    Kato, A.4    Honma, T.5    Matsumoto, K.6
  • 80
    • 70350443463 scopus 로고    scopus 로고
    • Mumps virus Enders strain is sensitive to interferon (IFN) despite encoding a functional IFN antagonist
    • Young D.F., Galiano M.C., Lemon K., Chen H.Y., Andrejeva J., Duprex W.P., et al. Mumps virus Enders strain is sensitive to interferon (IFN) despite encoding a functional IFN antagonist. J Gen Virol 2009, 90:2731-2738.
    • (2009) J Gen Virol , vol.90 , pp. 2731-2738
    • Young, D.F.1    Galiano, M.C.2    Lemon, K.3    Chen, H.Y.4    Andrejeva, J.5    Duprex, W.P.6
  • 81
    • 0016721708 scopus 로고
    • Passage history, properties, and applicability of the attenuated vaccinia virus strain MVA
    • Mayr A., Hochstein-Mintzel V., Stickl H. Abstammung, Eigenschaften und Verwendung des attenuierten vaccinia-stammes MVA. Infection 1975, 3:6-14.
    • (1975) Infection , vol.3 , pp. 6-14
    • Mayr, A.1    Hochstein-Mintzel, V.2    Stickl, H.3
  • 82
    • 0025876805 scopus 로고
    • Mapping of deletions in the genome of the highly attenuated vaccinia virus MVA and their influence on virulence
    • Meyer H., Sutter G., Mayr A. Mapping of deletions in the genome of the highly attenuated vaccinia virus MVA and their influence on virulence. J Gen Virol 1991, 72:1031-1038.
    • (1991) J Gen Virol , vol.72 , pp. 1031-1038
    • Meyer, H.1    Sutter, G.2    Mayr, A.3
  • 83
    • 0032503233 scopus 로고    scopus 로고
    • The complete genomic sequence of the modified vaccinia Ankara strain: comparison with other orthopoxviruses
    • Antoine G., Scheiflinger F., Dorner F., Falkner F.G. The complete genomic sequence of the modified vaccinia Ankara strain: comparison with other orthopoxviruses. Virology 1998, 244:365-396.
    • (1998) Virology , vol.244 , pp. 365-396
    • Antoine, G.1    Scheiflinger, F.2    Dorner, F.3    Falkner, F.G.4
  • 84
    • 65549092767 scopus 로고    scopus 로고
    • Expanding the repertoire of modified vaccinia Ankara-based vaccine vectors via genetic complementation strategies
    • Garber D.A., O'Mara L.A., Zhao J., Gangadhara S., An I., Feinberg M.B. Expanding the repertoire of modified vaccinia Ankara-based vaccine vectors via genetic complementation strategies. PLoS One 2009, 4(5):e5445. 10.1371/journal.pone.0005445.
    • (2009) PLoS One , vol.4 , Issue.5
    • Garber, D.A.1    O'Mara, L.A.2    Zhao, J.3    Gangadhara, S.4    An, I.5    Feinberg, M.B.6
  • 85
    • 0031585552 scopus 로고    scopus 로고
    • Host range and cytopathogenicity of the highly attenuated MVA strain of vaccinia virus: propagation and generation of recombinant viruses in a nonhuman mammalian cell line
    • Carroll M.W., Moss B. Host range and cytopathogenicity of the highly attenuated MVA strain of vaccinia virus: propagation and generation of recombinant viruses in a nonhuman mammalian cell line. Virology 1997, 238:198-211.
    • (1997) Virology , vol.238 , pp. 198-211
    • Carroll, M.W.1    Moss, B.2
  • 86
    • 65249141684 scopus 로고    scopus 로고
    • Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in mycobacterium tuberculosis-infected individuals
    • Sander C.R., Pathan A.A., Beveridge N.E.R., Poulton I., Minassian A., Alder N., et al. Safety and immunogenicity of a new tuberculosis vaccine, MVA85A, in mycobacterium tuberculosis-infected individuals. Am J Respir Crit Care Med 2009, 179:724-733.
    • (2009) Am J Respir Crit Care Med , vol.179 , pp. 724-733
    • Sander, C.R.1    Pathan, A.A.2    Beveridge, N.E.R.3    Poulton, I.4    Minassian, A.5    Alder, N.6
  • 87
    • 58149396490 scopus 로고    scopus 로고
    • IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine
    • Kennedy J.S., Greenberg R.N. IMVAMUNE: modified vaccinia Ankara strain as an attenuated smallpox vaccine. Expert Rev Vaccines 2009, 8(1):13-24.
    • (2009) Expert Rev Vaccines , vol.8 , Issue.1 , pp. 13-24
    • Kennedy, J.S.1    Greenberg, R.N.2
  • 88
    • 0034016812 scopus 로고    scopus 로고
    • Simian virus 40, poliovirus vaccines, and human cancer: research progress versus media and public interests
    • Butel J.S. Simian virus 40, poliovirus vaccines, and human cancer: research progress versus media and public interests. Bull World Health Organ 2000, 78:195-198.
    • (2000) Bull World Health Organ , vol.78 , pp. 195-198
    • Butel, J.S.1
  • 89
    • 0028108229 scopus 로고
    • The cell binding carboxyterminal undecapeptide of SV40 tumour antigen provides protective cell-dependent immunity
    • Hanagarth H.G., Obert M., Hess R., Haessler C., Braun D.G., Brandner G. The cell binding carboxyterminal undecapeptide of SV40 tumour antigen provides protective cell-dependent immunity. Vaccine 1994, 12:1197-1202.
    • (1994) Vaccine , vol.12 , pp. 1197-1202
    • Hanagarth, H.G.1    Obert, M.2    Hess, R.3    Haessler, C.4    Braun, D.G.5    Brandner, G.6
  • 90
    • 0031986203 scopus 로고    scopus 로고
    • Protection of mice against SV40 tumours by Pam3Cys, MTP-PE and Pam3Cys conjugated with the SV40T antigen derived peptide K(698)-T(708)
    • Obert M., Pleuger H., Hanagth H.G., SchulteMönting J., Wiesmüller K.H., Braun D., et al. Protection of mice against SV40 tumours by Pam3Cys, MTP-PE and Pam3Cys conjugated with the SV40T antigen derived peptide K(698)-T(708). Vaccine 1998, 16:161-169.
    • (1998) Vaccine , vol.16 , pp. 161-169
    • Obert, M.1    Pleuger, H.2    Hanagth, H.G.3    SchulteMönting, J.4    Wiesmüller, K.H.5    Braun, D.6
  • 91
    • 0030831686 scopus 로고    scopus 로고
    • DNA-damage-inducible p53 activity in SV40-transformed cells
    • Hess R.D., Brandner G. DNA-damage-inducible p53 activity in SV40-transformed cells. Oncogene 1997, 15:2501-2504.
    • (1997) Oncogene , vol.15 , pp. 2501-2504
    • Hess, R.D.1    Brandner, G.2
  • 93
    • 0034114026 scopus 로고    scopus 로고
    • UKCCCR guidelines for the use of cell lines in cancer research
    • Masters J.R., Twentyman W., Arlett P., Daley C., Davis R., Doyle J., et al. UKCCCR guidelines for the use of cell lines in cancer research. Br J Cancer 2000, 82(9):1495-1499.
    • (2000) Br J Cancer , vol.82 , Issue.9 , pp. 1495-1499
    • Masters, J.R.1    Twentyman, W.2    Arlett, P.3    Daley, C.4    Davis, R.5    Doyle, J.6
  • 94
    • 0034934077 scopus 로고    scopus 로고
    • Short tandem repeat profiling provides an international reference standard for human cell lines
    • Masters J.R. Short tandem repeat profiling provides an international reference standard for human cell lines. Proc Natl Acad Sci U S A 2002, 98:8012-8017.
    • (2002) Proc Natl Acad Sci U S A , vol.98 , pp. 8012-8017
    • Masters, J.R.1
  • 95
    • 84858706626 scopus 로고    scopus 로고
    • US FDA, CBER, Vaccines and related biological products advisory committee meeting, Wednesday, 16 May
    • US FDA, CBER, Vaccines and related biological products advisory committee meeting, Wednesday, 16 May 2001. http://www.fda.gov/ohrms/dockets/ac/01/transcripts/3750t1_01.pdf.
    • (2001)
  • 96
    • 84858697793 scopus 로고    scopus 로고
    • WHO/DRAFT/4 May Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks Proposed replacement of TRS 878, Annex 1, .
    • WHO/DRAFT/4 May 2010 Recommendations for the evaluation of animal cell cultures as substrates for the manufacture of biological medicinal products and for the characterization of cell banks Proposed replacement of TRS 878, Annex 1, . http://www.who.int/biologicals/publications/trs/areas/vaccines/cells/Cell_Substrates_for_public_consultation_HK_4_May2.pdf.
    • (2010)
  • 97
    • 45849142510 scopus 로고    scopus 로고
    • The tumourigenicity diversification in human embryonic kidney 293 cell line cultured in vitro
    • Shen C., Gu M., Song C., Miao L., Hu L., Liang D., et al. The tumourigenicity diversification in human embryonic kidney 293 cell line cultured in vitro. Biologicals 2008, 36(4):263-268.
    • (2008) Biologicals , vol.36 , Issue.4 , pp. 263-268
    • Shen, C.1    Gu, M.2    Song, C.3    Miao, L.4    Hu, L.5    Liang, D.6
  • 98
    • 33644633299 scopus 로고    scopus 로고
    • Safety assessment of Madin Darby canine kidney cells as vaccine substrate
    • Medema J.K., Meijer J., Kersten A.J., Horton R. Safety assessment of Madin Darby canine kidney cells as vaccine substrate. Dev Biol 2006, 123:243-250.
    • (2006) Dev Biol , vol.123 , pp. 243-250
    • Medema, J.K.1    Meijer, J.2    Kersten, A.J.3    Horton, R.4
  • 99
    • 33644843641 scopus 로고    scopus 로고
    • Molecular mechanisms of human carcinogenesis
    • Coleman W.B., Tsongalis G.J. Molecular mechanisms of human carcinogenesis. EXS 2006, (96):321-349.
    • (2006) EXS , Issue.96 , pp. 321-349
    • Coleman, W.B.1    Tsongalis, G.J.2
  • 100
    • 73349132626 scopus 로고    scopus 로고
    • Field effect in cancer-an update
    • Chai H., Brown R.E. Field effect in cancer-an update. Ann Clin Lab Sci 2009, 39:331-337.
    • (2009) Ann Clin Lab Sci , vol.39 , pp. 331-337
    • Chai, H.1    Brown, R.E.2
  • 101
    • 0037469079 scopus 로고    scopus 로고
    • Ras superfamily monomeric G proteins in carcinoma cell motility
    • Oxford G., Theodorescu D. Ras superfamily monomeric G proteins in carcinoma cell motility. Cancer Lett 2003, 189(2):117-128.
    • (2003) Cancer Lett , vol.189 , Issue.2 , pp. 117-128
    • Oxford, G.1    Theodorescu, D.2
  • 102
    • 38349099897 scopus 로고    scopus 로고
    • Assessing the tumorigenic phenotype of Vero cells in adult and newborn mice
    • Manohar M., Orrison B., Peden K., Lewis A.M. Assessing the tumorigenic phenotype of Vero cells in adult and newborn mice. Biologicals 2008, 36(1):65-72.
    • (2008) Biologicals , vol.36 , Issue.1 , pp. 65-72
    • Manohar, M.1    Orrison, B.2    Peden, K.3    Lewis, A.M.4
  • 103
    • 0000943342 scopus 로고
    • Agar suspension culture for the selective assay of cells transformed by polyoma virus
    • McPherson I., Montagnier I. Agar suspension culture for the selective assay of cells transformed by polyoma virus. Virology 1964, 23:291-294.
    • (1964) Virology , vol.23 , pp. 291-294
    • McPherson, I.1    Montagnier, I.2
  • 104
    • 0020962931 scopus 로고
    • Human muscle: a model for the study of human neoplasia
    • Petricciani J.C., Levenbook I., Locke R. Human muscle: a model for the study of human neoplasia. Invest New Drugs 1983, 1:297-302.
    • (1983) Invest New Drugs , vol.1 , pp. 297-302
    • Petricciani, J.C.1    Levenbook, I.2    Locke, R.3
  • 105
    • 0036549592 scopus 로고    scopus 로고
    • HeLa cells 50 years on: the good, the bad and the ugly
    • Masters J.R. HeLa cells 50 years on: the good, the bad and the ugly. Nat Rev Cancer 2002, 2:315-319.
    • (2002) Nat Rev Cancer , vol.2 , pp. 315-319
    • Masters, J.R.1
  • 106
    • 0023474361 scopus 로고
    • Risk of neoplastic transformation from cellular DNA: calculations using the oncogene model
    • Petricciani J.C., Regan P.J. Risk of neoplastic transformation from cellular DNA: calculations using the oncogene model. Dev Biol Stand 1987, 68:43-49.
    • (1987) Dev Biol Stand , vol.68 , pp. 43-49
    • Petricciani, J.C.1    Regan, P.J.2
  • 107
    • 84858700824 scopus 로고    scopus 로고
    • CPMP/BWP/1143/00 Position statement on the use of tumourigenic cells of human origin for the production of biological and biotechnological medicinal products.
    • CPMP/BWP/1143/00 Position statement on the use of tumourigenic cells of human origin for the production of biological and biotechnological medicinal products.
  • 109
    • 25144471241 scopus 로고    scopus 로고
    • Genomics: massively parallel sequencing
    • [published online 14 September 2005]
    • Rogers Y.H., Venter J.C. Genomics: massively parallel sequencing. Nature 15 September 2005, 437:326-327. [published online 14 September 2005]. 10.1038/437326a.
    • (2005) Nature , vol.437 , pp. 326-327
    • Rogers, Y.H.1    Venter, J.C.2
  • 110
    • 77952953556 scopus 로고    scopus 로고
    • Massively parallel sequencing, a new method for detecting adventitious agents
    • [24 March, Epub ahead of print]
    • Onions D., Kolman J. Massively parallel sequencing, a new method for detecting adventitious agents. Biologicals 2010, 38(3):377-380. [24 March, Epub ahead of print].
    • (2010) Biologicals , vol.38 , Issue.3 , pp. 377-380
    • Onions, D.1    Kolman, J.2
  • 111
    • 78650533823 scopus 로고    scopus 로고
    • Analysis of porcine circovirus type 1 detected in Rotarix vaccine
    • [18 November, Epub ahead of print]
    • Baylis S.A., Finsterbusch T., Bannert N., Blümel J., Mankertz A. Analysis of porcine circovirus type 1 detected in Rotarix vaccine. Vaccine 2011, 29(4):690-697. [18 November, Epub ahead of print].
    • (2011) Vaccine , vol.29 , Issue.4 , pp. 690-697
    • Baylis, S.A.1    Finsterbusch, T.2    Bannert, N.3    Blümel, J.4    Mankertz, A.5
  • 112
    • 63349084710 scopus 로고    scopus 로고
    • Cryopreservation and banking of mammalian cell lines
    • Stacey G.N., Masters J.R. Cryopreservation and banking of mammalian cell lines. Nat Protoc 2008, 12:1981-1989.
    • (2008) Nat Protoc , vol.12 , pp. 1981-1989
    • Stacey, G.N.1    Masters, J.R.2
  • 113
    • 84855564480 scopus 로고    scopus 로고
    • Introduction to workshop: adventitious viruses in biologics-detection and mitigation strategies
    • Khan A.S., Hughes P., Wiebe M. Introduction to workshop: adventitious viruses in biologics-detection and mitigation strategies. PDA J Pharm Sci Technol 2011, 65:544-546.
    • (2011) PDA J Pharm Sci Technol , vol.65 , pp. 544-546
    • Khan, A.S.1    Hughes, P.2    Wiebe, M.3


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