메뉴 건너뛰기




Volumn 436, Issue 2, 1999, Pages 137-156

Genotoxicity testing of biotechnology-derived products: Report of a GUM task force

Author keywords

Biotechnology products; Compilation of industry studies; Genotoxicity; Relevance; Review of literature

Indexed keywords

BIOLOGICAL PRODUCT; MUTAGENIC AGENT; RECOMBINANT PROTEIN;

EID: 0033093819     PISSN: 13835742     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1383-5742(99)00002-2     Document Type: Article
Times cited : (12)

References (50)
  • 1
    • 0030047346 scopus 로고    scopus 로고
    • The human inflammatory response
    • J.H. Levy, The human inflammatory response, J. Cardiovasc. Pharmacol. 27 (1996) S31-S37.
    • (1996) J. Cardiovasc. Pharmacol. , vol.27
    • Levy, J.H.1
  • 2
    • 0030581771 scopus 로고    scopus 로고
    • Genetic toxicity of cytokines
    • J.R. Lazutka, Genetic toxicity of cytokines, Mutat. Res. 361 (1996) 95-105.
    • (1996) Mutat. Res. , vol.361 , pp. 95-105
    • Lazutka, J.R.1
  • 3
    • 0025190374 scopus 로고
    • Effect of interleukin-2 on cell proliferation, sisterchromatid exchange induction, and nuclear stress protein phosphorylation in PHA-stimulated Fischer 344 rat spleen lymphocytes: Modulation by 2-mercaptoethanol, Environ
    • S.M. Morris, A. Aidoo, O.E. Domon, L.J. McGarrity, R.L. Kodell, H.M. Schol, W.O. Hinson, J.L. Pipkin, D.A. Casciano, Effect of interleukin-2 on cell proliferation, sisterchromatid exchange induction, and nuclear stress protein phosphorylation in PHA-stimulated Fischer 344 rat spleen lymphocytes: modulation by 2-mercaptoethanol, Environ. Mol. Mutagen. 15 (1990) 10-18.
    • (1990) Mol. Mutagen. , vol.15 , pp. 10-18
    • Morris, S.M.1    Aidoo, A.2    Domon, O.E.3    McGarrity, L.J.4    Kodell, R.L.5    Schol, H.M.6    Hinson, W.O.7    Pipkin, J.L.8    Casciano, D.A.9
  • 4
    • 0025882951 scopus 로고
    • Chromosomal aberrations during Interferon therapy for chronic myelogenous leukaemia
    • F. Hild, M. Freund, C. Fonatsch, Chromosomal aberrations during Interferon therapy for chronic myelogenous leukaemia, New Engl. J. Med. 325 (1991) 132.
    • (1991) New Engl. J. Med. , vol.325 , pp. 132
    • Hild, F.1    Freund, M.2    Fonatsch, C.3
  • 6
    • 33645718347 scopus 로고
    • Effects of cytokines and nitric oxide donors on insulin secretion, cyclic nucleotides, glucose metabolism and DNA damage: Relation to nitric oxide synthase activity and nitrite production in Insulin secretion and pancreatic B-cell research
    • P.R. Flatt, S. Lenzen (Eds.), UK.
    • I.C. Green, J.M. Cunningham, C.A. Delaney, M.A. Titheradge, J.G. Mabley, M.H.L. Green, Effects of cytokines and nitric oxide donors on insulin secretion, cyclic nucleotides, glucose metabolism and DNA damage: relation to nitric oxide synthase activity and nitrite production in Insulin secretion and pancreatic B-cell research, in: P.R. Flatt, S. Lenzen (Eds.), Smith-Gordon Publ., UK., 1994.
    • (1994) Smith-Gordon Publ.
    • Green, I.C.1    Cunningham, J.M.2    Delaney, C.A.3    Titheradge, M.A.4    Mabley, J.G.5    Green, M.H.L.6
  • 8
    • 0027428461 scopus 로고
    • Endogenous nitric oxide induced by interleukin-1 β in rats islets of Langerhans and HIT-T15 cells causes significant DNA damage as measured by the 'comet' assay
    • C.A. Delaney, M.H.L. Green, J.E. Löwe, I.C. Green, Endogenous nitric oxide induced by interleukin-1 β in rats islets of Langerhans and HIT-T15 cells causes significant DNA damage as measured by the 'comet' assay, FEBS 33 (1993) 291-295.
    • (1993) FEBS , vol.33 , pp. 291-295
    • Delaney, C.A.1    Green, M.H.L.2    Löwe, J.E.3    Green, I.C.4
  • 9
    • 0030068610 scopus 로고    scopus 로고
    • Tumor necrosis factora and interferony inhibit insulin secretion and cause DNA damage in unweaned-rat islets: Extent of nitric oxide involvement
    • A. Dunger, J.M. Cunningham, C.A. Delaney, J.E. Löwe, M.H.L. Green, A.J. Bone, I.C. Green, Tumor necrosis factora and interferony inhibit insulin secretion and cause DNA damage in unweaned-rat islets: extent of nitric oxide involvement, Diabetes 45 (1996) 183-189.
    • (1996) Diabetes , vol.45 , pp. 183-189
    • Dunger, A.1    Cunningham, J.M.2    Delaney, C.A.3    Löwe, J.E.4    Green, M.H.L.5    Bone, A.J.6    Green, I.C.7
  • 10
    • 0026751947 scopus 로고
    • The L-arginine:nitric oxide pathway
    • S. Moncada, The L-arginine:nitric oxide pathway, Acta Physiol. Scand. 145 (1992) 201-227.
    • (1992) Acta Physiol. Scand. , vol.145 , pp. 201-227
    • Moncada, S.1
  • 12
    • 0028218474 scopus 로고
    • Chronic infections and inflammatory processes as cancer risk factors: Possible role of nitric oxide in carcinogenesis
    • H. Ohshima, H. Bartsch, Chronic infections and inflammatory processes as cancer risk factors: possible role of nitric oxide in carcinogenesis, Mutat. Res. 305 (1994) 253-264.
    • (1994) Mutat. Res. , vol.305 , pp. 253-264
    • Ohshima, H.1    Bartsch, H.2
  • 13
    • 0026322159 scopus 로고
    • Nitric oxide generation from L-arginine is required for optimal human peripheral blood lymphocyte DNA synthesis
    • D.T. Efron, S.J. Kirk, M.C. Regan, H.L. Wasserkrug, A. Barbul, Nitric oxide generation from L-arginine is required for optimal human peripheral blood lymphocyte DNA synthesis, Surgery 110 (1991) 327-334.
    • (1991) Surgery , vol.110 , pp. 327-334
    • Efron, D.T.1    Kirk, S.J.2    Regan, M.C.3    Wasserkrug, H.L.4    Barbul, A.5
  • 14
    • 0027175574 scopus 로고
    • Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietins
    • N. Yajima, Y. Kurata, T. Sawai, Y. Takeshita, Comparative studies in induction of micronuclei by three genetically recombinant and urinary human erythropoietins, Mutagenesis 8 (1993) 237-241.
    • (1993) Mutagenesis , vol.8 , pp. 237-241
    • Yajima, N.1    Kurata, Y.2    Sawai, T.3    Takeshita, Y.4
  • 15
    • 0027215247 scopus 로고
    • Induction of micronucleated erythrocytes by recombinant human erythropoietin
    • N. Yajima, Y. Kurata, T. Sawai, Y. Takeshita, Induction of micronucleated erythrocytes by recombinant human erythropoietin, Mutagenesis 8 (1993) 221-229.
    • (1993) Mutagenesis , vol.8 , pp. 221-229
    • Yajima, N.1    Kurata, Y.2    Sawai, T.3    Takeshita, Y.4
  • 16
    • 0027175572 scopus 로고
    • Genotoxicity of genetic recombinant human erythropoietin in a novel test system
    • N. Yajima, Y. Kurata, T. Sawai, Y. Takeshita, Genotoxicity of genetic recombinant human erythropoietin in a novel test system, Mutagenesis 8 (3) (1993) 231-236.
    • (1993) Mutagenesis , vol.8 , Issue.3 , pp. 231-236
    • Yajima, N.1    Kurata, Y.2    Sawai, T.3    Takeshita, Y.4
  • 17
    • 0025943841 scopus 로고
    • Prior bleeding enhances the sensitivity of the in vivo micronucleus test
    • O. Hirai, Y. Miyamae, Y. Fujino, H. Izumi, A. Miyamoto, H. Noguchi, Prior bleeding enhances the sensitivity of the in vivo micronucleus test, Mutat. Res. 264 (1991) 109-114.
    • (1991) Mutat. Res. , vol.264 , pp. 109-114
    • Hirai, O.1    Miyamae, Y.2    Fujino, Y.3    Izumi, H.4    Miyamoto, A.5    Noguchi, H.6
  • 18
    • 0021885136 scopus 로고
    • Evaluation of nongenotoxic and genotoxic factors modulating the frequency of micronucleated erythrocytes in the peripheral blood of mice
    • G. Steinheider, R. Neth, H. Marquardt, Evaluation of nongenotoxic and genotoxic factors modulating the frequency of micronucleated erythrocytes in the peripheral blood of mice, Cell. Biol. Toxicol. 1 (1985) 197-211.
    • (1985) Cell. Biol. Toxicol. , vol.1 , pp. 197-211
    • Steinheider, G.1    Neth, R.2    Marquardt, H.3
  • 19
    • 0031968927 scopus 로고    scopus 로고
    • Phenolphthalein: A sheep in wolf's clothing?
    • H.E. Holden, Phenolphthalein: a sheep in wolf's clothing?, Environ. Mol. Mutagen. 31 (1998) 103-104.
    • (1998) Environ. Mol. Mutagen. , vol.31 , pp. 103-104
    • Holden, H.E.1
  • 20
    • 0021261468 scopus 로고
    • Clastogenic effects of biosynthetic human growth hormone in Snell dwarf mice and CHO cells in vitro
    • P.P.W. van Buul, P. van Buul-Offers, Clastogenic effects of biosynthetic human growth hormone in Snell dwarf mice and CHO cells in vitro, Mutat. Res. 127 (1984) 61-64.
    • (1984) Mutat. Res. , vol.127 , pp. 61-64
    • Van Buul, P.P.W.1    Van Buul-Offers, P.2
  • 22
    • 0030659547 scopus 로고    scopus 로고
    • Risk of leukemia in children treated with human growth hormone: Review and reanalysis
    • D.B. Allen, A.C. Rundle, D.A. Graves, S.L. Blethen, Risk of leukemia in children treated with human growth hormone: review and reanalysis, J. Pediatr. 131 (1997) S32-S36.
    • (1997) J. Pediatr. , vol.131
    • Allen, D.B.1    Rundle, A.C.2    Graves, D.A.3    Blethen, S.L.4
  • 24
    • 0030952928 scopus 로고    scopus 로고
    • Comparative studies of the mitogenic effects of epidermal growth factor and transforming growth factor-alpha and the expression of various growth factors in neoplastic and non-neoplastic prostatic cell lines
    • H.E. Jones, C.L. Eaton, D. Barrow, C.M. Dutkowski, J.M. Gee, K. Griffiths, Comparative studies of the mitogenic effects of epidermal growth factor and transforming growth factor-alpha and the expression of various growth factors in neoplastic and non-neoplastic prostatic cell lines, Prostate 30 (1997) 219-231.
    • (1997) Prostate , vol.30 , pp. 219-231
    • Jones, H.E.1    Eaton, C.L.2    Barrow, D.3    Dutkowski, C.M.4    Gee, J.M.5    Griffiths, K.6
  • 25
    • 0025163524 scopus 로고
    • Too many rodent carcinogens: Mitogenesis increases mutagenesis
    • B.N. Ames, L.S. Gold, Too many rodent carcinogens: mitogenesis increases mutagenesis, Science 249 (1990) 970-971.
    • (1990) Science , vol.249 , pp. 970-971
    • Ames, B.N.1    Gold, L.S.2
  • 26
    • 0030697270 scopus 로고    scopus 로고
    • Frequencies of polycentric chromosomes following combinational treatments of Chinese hamster ovary cells with restriction endonucleases and X-rays, bleomycin or DNase I
    • C. Johannes, W.D. Heller, P. Eke, G. Obe, Frequencies of polycentric chromosomes following combinational treatments of Chinese hamster ovary cells with restriction endonucleases and X-rays, bleomycin or DNase I, Mutat. Res. 373 (1997)237-244.
    • (1997) Mutat. Res. , vol.373 , pp. 237-244
    • Johannes, C.1    Heller, W.D.2    Eke, P.3    Obe, G.4
  • 27
    • 0030806585 scopus 로고    scopus 로고
    • Localisation of chromosome breakpoints induced by DNAse I in Chinese hamster ovary (CHO) cells
    • O.A. Folie, E. Boccardo, G. Obe, Localisation of chromosome breakpoints induced by DNAse I in Chinese hamster ovary (CHO) cells, Chromosoma 106 (1997) 391-399.
    • (1997) Chromosoma , vol.106 , pp. 391-399
    • Folie, O.A.1    Boccardo, E.2    Obe, G.3
  • 28
    • 0028241757 scopus 로고
    • Pharmaco-toxicological report: Pulmozyme rhDNAse Genentech Hum
    • J.D. Green, Pharmaco-toxicological report: pulmozyme rhDNAse Genentech Hum, Exp. Toxicol. 13 (1994) 1-42.
    • (1994) Exp. Toxicol. , vol.13 , pp. 1-42
    • Green, J.D.1
  • 29
    • 0029071573 scopus 로고
    • Bacterial ribonuclease: Mutagenic effect in bacterial test systems
    • O.N. Ilinskaya, O.B. Ivanchenko, N.S. Karamova, Bacterial ribonuclease: mutagenic effect in bacterial test systems, Mutagenesis 10(1995) 165-170.
    • (1995) Mutagenesis , vol.10 , pp. 165-170
    • Ilinskaya, O.N.1    Ivanchenko, O.B.2    Karamova, N.S.3
  • 32
    • 0028210378 scopus 로고
    • An overview of the safety evaluation of the Rhizomucor miehei lipase enzyme
    • A. Broadmeadow, C. Clare, A.S. De Boer, An overview of the safety evaluation of the Rhizomucor miehei lipase enzyme, Food Addit. Contam. 11 (1994) 105-119.
    • (1994) Food Addit. Contam. , vol.11 , pp. 105-119
    • Broadmeadow, A.1    Clare, C.2    De Boer, A.S.3
  • 33
    • 0023942667 scopus 로고
    • Safety evaluation of lipase from Mucor-Mihei for inter-esterification of edible oils and fats
    • M. Stavnsbjerg, A.S. DeBoer, B.F. Jensen, Safety evaluation of lipase from Mucor-Mihei for inter-esterification of edible oils and fats, Food Addit. Contam. 5 (1988) 251-265.
    • (1988) Food Addit. Contam. , vol.5 , pp. 251-265
    • Stavnsbjerg, M.1    Deboer, A.S.2    Jensen, B.F.3
  • 35
    • 0022254581 scopus 로고
    • Mutagenicity of β-glucuronidase in the Ames test
    • M. Cerna, Mutagenicity of β-glucuronidase in the Ames test, Mutat. Res. 143 (1985) 167-172.
    • (1985) Mutat. Res. , vol.143 , pp. 167-172
    • Cerna, M.1
  • 37
    • 0029552185 scopus 로고
    • Regulatory issues in the use of DNA vaccines
    • P.D. Minor, Regulatory issues in the use of DNA vaccines, Ann. NY Acad. Sei. 772 (1995) 170-177.
    • (1995) Ann. NY Acad. Sei. , vol.772 , pp. 170-177
    • Minor, P.D.1
  • 38
    • 33645722645 scopus 로고
    • Genotoxicity tesing of pharmaceuticals: The need for a rational test design
    • Nordwijkerhout
    • S.M. Galloway, Genotoxicity tesing of pharmaceuticals: the need for a rational test design, Presentation at the 25th Annual Meeting EEMS, Nordwijkerhout, 1995.
    • (1995) 25th Annual Meeting EEMS
    • Galloway, S.M.1
  • 39
    • 17444435761 scopus 로고    scopus 로고
    • Cellular cytotoxic response induced by DNA vaccination in HIV-1-infected patients
    • G. Calarota, S. Bratt, A.-C. Nordlund, V. Leandersson, B. Sandström, B. Wahren, Cellular cytotoxic response induced by DNA vaccination in HIV-1-infected patients, Lancet 351 (1998) 1320-1325.
    • (1998) Lancet , vol.351 , pp. 1320-1325
    • Calarota, G.1    Bratt, S.2    Nordlund, A.-C.3    Leandersson, V.4    Sandström, B.5    Wahren, B.6
  • 40
    • 0031423677 scopus 로고    scopus 로고
    • GH rank colocalization of antisense RNAs and ribozymes with their target mRNAs
    • G.M. Arndt, GH rank colocalization of antisense RNAs and ribozymes with their target mRNAs, Genome 40 (1997) 785-797.
    • (1997) Genome , vol.40 , pp. 785-797
    • Arndt, G.M.1
  • 41
    • 0030059301 scopus 로고    scopus 로고
    • Mutagenesis in mammalian cells induced by triple helix formation and transcription-coupled repair
    • G. Wang, M.M. Seidman, P.M. Glazer, Mutagenesis in mammalian cells induced by triple helix formation and transcription-coupled repair, Science 271 (1996) 802-805.
    • (1996) Science , vol.271 , pp. 802-805
    • Wang, G.1    Seidman, M.M.2    Glazer, P.M.3
  • 42
    • 0028596398 scopus 로고
    • Transcription-coupled repair and human disease
    • P.C. Hanawalt, Transcription-coupled repair and human disease, Science 266 (1994) 1957-1958.
    • (1994) Science , vol.266 , pp. 1957-1958
    • Hanawalt, P.C.1
  • 44
    • 0030560733 scopus 로고    scopus 로고
    • Anti-gene therapy: The use of ribozymes to inhibit gene function
    • L.A. Couture, D.T. Stinchcomb, Anti-gene therapy: the use of ribozymes to inhibit gene function, Trends Genet. 12 (1996) 510-515.
    • (1996) Trends Genet. , vol.12 , pp. 510-515
    • Couture, L.A.1    Stinchcomb, D.T.2
  • 45
    • 0029410699 scopus 로고
    • Group II intron ribozymes that cleave DNA and RNA linkages with similar efficiency, and lack contacts with substrate 2′-hydroxyl groups
    • E.A. Griffin Jr., Z. Qin, W.J. Michels Jr., A.M. Pyle, Group II intron ribozymes that cleave DNA and RNA linkages with similar efficiency, and lack contacts with substrate 2′-hydroxyl groups, Chem. Biol. 2 (1995) 761-770.
    • (1995) Chem. Biol. , vol.2 , pp. 761-770
    • Griffin Jr., E.A.1    Qin, Z.2    Michels Jr., W.J.3    Pyle, A.M.4
  • 46
    • 0029095541 scopus 로고
    • Special considerations for conducting genotoxicity tests with protein materials
    • D.J. Kirkland, N.N. Kim, Special considerations for conducting genotoxicity tests with protein materials, Mutagenesis 10 (1995) 393-398.
    • (1995) Mutagenesis , vol.10 , pp. 393-398
    • Kirkland, D.J.1    Kim, N.N.2
  • 47
    • 0031029532 scopus 로고    scopus 로고
    • Meeting report of the Industrial Genotoxicology Group. London, December 1995
    • S. Dean, Meeting report of the Industrial Genotoxicology Group. London, December 1995, Mutagenesis 12 (1997) 49-50.
    • (1997) Mutagenesis , vol.12 , pp. 49-50
    • Dean, S.1
  • 48
    • 5944226118 scopus 로고
    • Clearance of impurities from protein and peptide biotherapeutics, Pharmaceutical Technology Europe May
    • G. Sofer, Biotechnology product validation: Part 4. Clearance of impurities from protein and peptide biotherapeutics, Pharmaceutical Technology Europe (May 1994) 29-32.
    • (1994) Biotechnology Product Validation: Part 4 , pp. 29-32
    • Sofer, G.1
  • 50
    • 33645726585 scopus 로고    scopus 로고
    • Human biological relevance and the use of threshold arguments in regulatory genotoxicology assessment: Experience with pharmaceuticals
    • submitted
    • L. Müller, P. Kasper, Human biological relevance and the use of threshold arguments in regulatory genotoxicology assessment: experience with pharmaceuticals, Mutat. Res. (submitted).
    • Mutat. Res.
    • Müller, L.1    Kasper, P.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.