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Volumn 20, Issue 1, 2007, Pages 46-55

A revalidation study of viral clearance in the purification of monoclonal antibody CB.Hep-1

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; HYDROCHLORIC ACID; MONOCLONAL ANTIBODY; MONOCLONAL ANTIBODY CB HEP 1; UNCLASSIFIED DRUG;

EID: 33846414322     PISSN: 1542166X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (3)

References (23)
  • 1
    • 0000090105 scopus 로고
    • High purity recombinant human alpha-2 interferon free from oligomeric forms in E. Coli. Highlights Modern
    • Quiñones Y, Agraz A, Silva A, Padrón G, Mella C, Díaz R, et al. High purity recombinant human alpha-2 interferon free from oligomeric forms in E. Coli. Highlights Modern Biochem 1989; 2:1237-1246.
    • (1989) Biochem , vol.2 , pp. 1237-1246
    • Quiñones, Y.1    Agraz, A.2    Silva, A.3    Padrón, G.4    Mella, C.5    Díaz, R.6
  • 2
    • 0022632219 scopus 로고
    • Isolation y characterization of single chain urokinase (prourokinase) and urokinasa-inhibitor complex
    • Stum DC, Thienpont M, Collen D. Isolation y characterization of single chain urokinase (prourokinase) and urokinasa-inhibitor complex. J. Biological Chemistry 1986; 261:1267-1273.
    • (1986) J. Biological Chemistry , vol.261 , pp. 1267-1273
    • Stum, D.C.1    Thienpont, M.2    Collen, D.3
  • 3
    • 0025459195 scopus 로고
    • Viral contamination of monoclonal antibody preparations: Potential problems and possible solutions
    • Harbour C, Woodhouse G. Viral contamination of monoclonal antibody preparations: potential problems and possible solutions. Cytotechnology 1990; 4:3-12.
    • (1990) Cytotechnology , vol.4 , pp. 3-12
    • Harbour, C.1    Woodhouse, G.2
  • 4
    • 0029269285 scopus 로고
    • Transmissible spongioform encephalopathies
    • Hart CA. Transmissible spongioform encephalopathies. J Med Microbiol. 1995; 42:153-155.
    • (1995) J Med Microbiol , vol.42 , pp. 153-155
    • Hart, C.A.1
  • 5
    • 0032173017 scopus 로고    scopus 로고
    • Inactivation kinetics of model and relevant bloodborne viruses by treatment with sodium hydroxide and heat
    • Borovec S, Broumis C, Adcock W, Fang R, Uren E. Inactivation kinetics of model and relevant bloodborne viruses by treatment with sodium hydroxide and heat. Biologicals 1998; 26, 3:237-244.
    • (1998) Biologicals , vol.26 , Issue.3 , pp. 237-244
    • Borovec, S.1    Broumis, C.2    Adcock, W.3    Fang, R.4    Uren, E.5
  • 6
    • 85066231345 scopus 로고
    • EEC regulatory document, note for guidance: Validation of viral removal and inactivation procedure
    • Committee for Proprietary Medicinal Products
    • Committee for Proprietary Medicinal Products. EEC regulatory document, note for guidance: Validation of viral removal and inactivation procedure. Biological, 1991; 19:247-25.
    • (1991) Biological , vol.19 , pp. 247-225
  • 7
    • 0029852635 scopus 로고    scopus 로고
    • Process validation for virus removal
    • Darling JA, Spaltro JJ. Process validation for virus removal. Biopharm 1996; 10:42-50.
    • (1996) Biopharm , vol.10 , pp. 42-50
    • Darling, J.A.1    Spaltro, J.J.2
  • 8
    • 0024329357 scopus 로고
    • Adventitious viral agents in biological product
    • Minor P. Adventitious viral agents in biological product. Develop. Biol. Standard 1989; 70:173-179.
    • (1989) Develop. Biol. Standard , vol.70 , pp. 173-179
    • Minor, P.1
  • 10
    • 0003766994 scopus 로고
    • Juran JM, Gryna MF, editors, 4th ed. New York: McGraw-Hill;
    • Juran JM, Gryna MF, editors Juran's quality control handbook, 4th ed. New York: McGraw-Hill; 1988.
    • (1988) Juran's quality control handbook
  • 11
    • 33846436220 scopus 로고    scopus 로고
    • Validation: Ensuring the accuracy of scaled-down chromatography method
    • Sofer G. Validation: ensuring the accuracy of scaled-down chromatography method. Biopharm 1998; 10:51-54.
    • (1998) Biopharm , vol.10 , pp. 51-54
    • Sofer, G.1
  • 12
    • 0001828027 scopus 로고
    • A mouse hybridoma cell line secreting IgG and IgM with specificity for the Hepatitis B surface antigen virus requirements for biological substances
    • Fontirrochi G, Dueñas M, Fernández E, Fuentes P Pérez M, Mainet D, et al., A mouse hybridoma cell line secreting IgG and IgM with specificity for the Hepatitis B surface antigen virus requirements for biological substances. Biotecnología Aplicada 1993; 10:25-30.
    • (1993) Biotecnología Aplicada , vol.10 , pp. 25-30
    • Fontirrochi, G.1    Dueñas, M.2    Fernández, E.3    Fuentes, P.4    Pérez, M.5    Mainet, D.6
  • 13
    • 0343314905 scopus 로고    scopus 로고
    • Large scale production of recombinant Hepatitis B surface antigen from Pichia pastoris
    • Hardy E, Martínez E, Diago D, Díaz R, González D, Herrera L. Large scale production of recombinant Hepatitis B surface antigen from Pichia pastoris. J. Biotechnology 2000; 17:155-157.
    • (2000) J. Biotechnology , vol.17 , pp. 155-157
    • Hardy, E.1    Martínez, E.2    Diago, D.3    Díaz, R.4    González, D.5    Herrera, L.6
  • 14
    • 0141654066 scopus 로고    scopus 로고
    • Antigen recognition characteristics and comparative performance in immunoaffinity purification of two monoclonal antibodies specific for the Hepatitis B virus surface antigen
    • Fernández ME, Díaz T, Galván A, Valdés R, González E, Ayala M, et al. Antigen recognition characteristics and comparative performance in immunoaffinity purification of two monoclonal antibodies specific for the Hepatitis B virus surface antigen. J Biotechnol. 1997; 56:69-80.
    • (1997) J Biotechnol , vol.56 , pp. 69-80
    • Fernández, M.E.1    Díaz, T.2    Galván, A.3    Valdés, R.4    González, E.5    Ayala, M.6
  • 15
    • 0037014561 scopus 로고    scopus 로고
    • Chromatographic removal combined with heat, acid and chaotropic inactivation of four model viruses
    • Valdés R, Ibarra N, Ruibal I, Bederraín A, Noa E, Herrera N, et al. Chromatographic removal combined with heat, acid and chaotropic inactivation of four model viruses. J. Biotechnology 2002; 96:251-258.
    • (2002) J. Biotechnology , vol.96 , pp. 251-258
    • Valdés, R.1    Ibarra, N.2    Ruibal, I.3    Bederraín, A.4    Noa, E.5    Herrera, N.6
  • 17
    • 0030696599 scopus 로고    scopus 로고
    • Demonstrating the process robustness for Chromatographie purification of a recombinant protein
    • Kelly DB, Jeening P, Wright R, Briaco C. Demonstrating the process robustness for Chromatographie purification of a recombinant protein. Biopharm 1997; 10:36-45.
    • (1997) Biopharm , vol.10 , pp. 36-45
    • Kelly, D.B.1    Jeening, P.2    Wright, R.3    Briaco, C.4
  • 18
    • 0027016748 scopus 로고
    • Experimental approaches to guarantee minimal risk of potential virus in purified monoclonal antibodies
    • Berthold W, Walter J, Werz W. Experimental approaches to guarantee minimal risk of potential virus in purified monoclonal antibodies. Cytotechnology 1992; 9:189-201.
    • (1992) Cytotechnology , vol.9 , pp. 189-201
    • Berthold, W.1    Walter, J.2    Werz, W.3
  • 19
    • 0014949207 scopus 로고
    • Cleavage of structural proteins during the assembly by bacteriophage T 4
    • Laemmli. UK. Cleavage of structural proteins during the assembly by bacteriophage T 4. Nature 1970; 270:680-685.
    • (1970) Nature , vol.270 , pp. 680-685
    • Laemmli, U.K.1
  • 20
    • 33745158157 scopus 로고
    • A simple method of estimating fifty per cent endpoints
    • Reed. LJ, Müench H. A simple method of estimating fifty per cent endpoints. Amer. J. Hyg. 1938; 27:493-487.
    • (1938) Amer. J. Hyg , vol.27 , pp. 493-487
    • Reed, L.J.1    Müench, H.2
  • 21
    • 0002625813 scopus 로고
    • Process validation for virus removal and inactivation
    • White EM, Grun BJ, Sur C-S, Sito FA. Process validation for virus removal and inactivation. BioPharm 1991; 4(5):30-33.
    • (1991) BioPharm , vol.4 , Issue.5 , pp. 30-33
    • White, E.M.1    Grun, B.J.2    Sur, C.-S.3    Sito, F.A.4
  • 23
    • 0031444857 scopus 로고    scopus 로고
    • The removal of model virus, poliovirus type 1 and canine parvovirus, during the purification of human albumin using ion-exchange chromatography procedures
    • Cameron R, Davies J, Adcock W, Mac Gregor A, Bargord RJ, Cossart Y, Harcour C. The removal of model virus, poliovirus type 1 and canine parvovirus, during the purification of human albumin using ion-exchange chromatography procedures. Biologicals 1997; 25:391-401.
    • (1997) Biologicals , vol.25 , pp. 391-401
    • Cameron, R.1    Davies, J.2    Adcock, W.3    Mac Gregor, A.4    Bargord, R.J.5    Cossart, Y.6    Harcour, C.7


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.