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Volumn 30, Issue 6, 2014, Pages 1341-1347

Virus elimination during the purification of monoclonal antibodies by column chromatography and additional steps

Author keywords

Gel sanitization; Monoclonal antibody purification; Virus elimination

Indexed keywords

CHLORINE COMPOUNDS; COLUMN CHROMATOGRAPHY; CONTAMINATION; ION EXCHANGE; MONOCLONAL ANTIBODIES; PURIFICATION; SODIUM HYDROXIDE; SURFACE PLASMON RESONANCE;

EID: 84914096114     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1984     Document Type: Article
Times cited : (20)

References (35)
  • 1
    • 77952692589 scopus 로고    scopus 로고
    • Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus
    • Victoria JG, Wang C, Jones MS, Jaing C, McLoughlin K, Gardner S, Delward EL. Viral nucleic acids in live-attenuated vaccines: detection of minority variants and an adventitious virus. J Virol. 2010;84:6033-6040.
    • (2010) J Virol , vol.84 , pp. 6033-6040
    • Victoria, J.G.1    Wang, C.2    Jones, M.S.3    Jaing, C.4    McLoughlin, K.5    Gardner, S.6    Delward, E.L.7
  • 2
    • 0032573874 scopus 로고    scopus 로고
    • Contamination of poliovirus vaccines with simian virus 40 (1955-1963) and subsequent cancer rates
    • Strickler HD, Rosenberg PS, Devesa SS, Hertel J, Fraumeni JF, Goedert JJ. Contamination of poliovirus vaccines with simian virus 40 (1955-1963) and subsequent cancer rates. JAMA. 1998;279:292-295.
    • (1998) JAMA , vol.279 , pp. 292-295
    • Strickler, H.D.1    Rosenberg, P.S.2    Devesa, S.S.3    Hertel, J.4    Fraumeni, J.F.5    Goedert, J.J.6
  • 4
    • 77951293218 scopus 로고    scopus 로고
    • US Food and Drug Administration. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use
    • US Food and Drug Administration; .
    • Centre for Biological Evaluation and Research (CBER), US Food and Drug Administration. Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. US Food and Drug Administration; 1997.
    • (1997)
  • 5
    • 0003724261 scopus 로고    scopus 로고
    • Requirements for the Use of Animal Cells as Invitro Substrates for the Production of Biologicals
    • WHO Technical Report Series; ;.
    • World Health Organisation (WHO). Requirements for the Use of Animal Cells as Invitro Substrates for the Production of Biologicals. WHO Technical Report Series; 1998;878.
    • (1998) , pp. 878
  • 6
    • 70349328625 scopus 로고    scopus 로고
    • Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
    • ICH Guideline ;Q5A(R1).
    • International Conference on Harmonisation (ICH). Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin. ICH Guideline 1999;Q5A(R1).
    • (1999)
  • 8
    • 4243611775 scopus 로고
    • Human therapeutic monoclonal Anti-D antibody produced in long-term hollow-fibre culture. I. The relationship between antibody productivity and metabolic parameters
    • In: Beuvery EC, Griffiths JB, Zeijlemaker WP, editors. . The Netherlands: Kluwer Academic Publishers; :-.
    • st Century. The Netherlands: Kluwer Academic Publishers; 1995:149-153.
    • (1995) st Century , pp. 149-153
    • Davis, J.M.1    Lavender, C.M.2    Bowes, K.J.3    Hana, J.A.J.4    Combridge, B.S.5    Kingsland, S.L.6
  • 9
    • 77956845120 scopus 로고
    • Validation of a primary capture process for production of human therapeutic monoclonal antibodies
    • In: Pyle DL, editor. . Royal Society of Chemistry. ; :-.
    • Baker RM, Brady AM, Combridge BS, Ejim SL, Kingsland SL, Lloyd DA, Roberts PL. Validation of a primary capture process for production of human therapeutic monoclonal antibodies. In: Pyle DL, editor. Seperations for Biotechnology. Royal Society of Chemistry. 1994; 3:53-59.
    • (1994) Seperations for Biotechnology , vol.3 , pp. 53-59
    • Baker, R.M.1    Brady, A.M.2    Combridge, B.S.3    Ejim, S.L.4    Kingsland, S.L.5    Lloyd, D.A.6    Roberts, P.L.7
  • 11
    • 77958589701 scopus 로고    scopus 로고
    • Recovery and purification process development for monoclonal antibody production
    • Liu H, Ma J, Winter C, Bayer R. Recovery and purification process development for monoclonal antibody production. MAbs. 2010;2:480-499.
    • (2010) MAbs , vol.2 , pp. 480-499
    • Liu, H.1    Ma, J.2    Winter, C.3    Bayer, R.4
  • 12
    • 77953045118 scopus 로고    scopus 로고
    • Analysis of viral clearance unit operations for monoclonal antibodies
    • Miesegaes G, Lute S, Brorson K. Analysis of viral clearance unit operations for monoclonal antibodies. Biotechnol Bioeng. 2010;106:238-246.
    • (2010) Biotechnol Bioeng , vol.106 , pp. 238-246
    • Miesegaes, G.1    Lute, S.2    Brorson, K.3
  • 14
    • 33847174630 scopus 로고    scopus 로고
    • Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins
    • Kemp C, Stucki M, Boschetti N. Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins. Biologicals 2007;35:35-42.
    • (2007) Biologicals , vol.35 , pp. 35-42
    • Kemp, C.1    Stucki, M.2    Boschetti, N.3
  • 15
    • 0037420743 scopus 로고    scopus 로고
    • 2003. Bracketing generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins
    • Brorson K, Krejci S, Lee K, Hamilton E, Stein K, Xu Y. 2003. Bracketing generic inactivation of rodent retroviruses by low pH treatment for monoclonal antibodies and recombinant proteins. Biotechnol Bioeng. 2003;82:321-329.
    • (2003) Biotechnol Bioeng , vol.82 , pp. 321-329
    • Brorson, K.1    Krejci, S.2    Lee, K.3    Hamilton, E.4    Stein, K.5    Xu, Y.6
  • 16
    • 0027828722 scopus 로고
    • Chromatograpic removal of viruses from plasma derivatives
    • Burnouf T. Chromatograpic removal of viruses from plasma derivatives. Dev Biol Stand. 1993;81:199-209.
    • (1993) Dev Biol Stand , vol.81 , pp. 199-209
    • Burnouf, T.1
  • 17
    • 58149241256 scopus 로고    scopus 로고
    • Anion exchange chromatography provides a robust, predictable process to ensure viral safety of biotechnology products
    • Strauss DM, Gorrell J, Plancarte M, Blank GS, Chen Q, Yang B. Anion exchange chromatography provides a robust, predictable process to ensure viral safety of biotechnology products. Biotechnol Bioeng. 2009;102:168-175.
    • (2009) Biotechnol Bioeng , vol.102 , pp. 168-175
    • Strauss, D.M.1    Gorrell, J.2    Plancarte, M.3    Blank, G.S.4    Chen, Q.5    Yang, B.6
  • 18
    • 84893786829 scopus 로고    scopus 로고
    • Viral clearance by flow-through mode ion exchange columns and membrane adsorbers
    • Miesegaes GR, Lute SC, Read EK, Brorson KA. Viral clearance by flow-through mode ion exchange columns and membrane adsorbers. Biotechnol Prog. 2014;30:124-131.
    • (2014) Biotechnol Prog , vol.30 , pp. 124-131
    • Miesegaes, G.R.1    Lute, S.C.2    Read, E.K.3    Brorson, K.A.4
  • 20
    • 35248888115 scopus 로고    scopus 로고
    • Virus inactivation by protein denaturants used in affinity chromatography
    • Roberts PL, Lloyd D. Virus inactivation by protein denaturants used in affinity chromatography. Biologicals. 2007;35:343-347.
    • (2007) Biologicals , vol.35 , pp. 343-347
    • Roberts, P.L.1    Lloyd, D.2
  • 21
    • 0031444857 scopus 로고    scopus 로고
    • The removal of model viruses, poliovirus type 1 and canine parvovirus, during the purification of human albumin using ion-exchange chromatographic procedures
    • Cameron R, Davies J, Adcock W, MacGregor A, Barford JP, Cossart Y, Harbour C. The removal of model viruses, poliovirus type 1 and canine parvovirus, during the purification of human albumin using ion-exchange chromatographic procedures. Biologicals. 1997;25:391-401.
    • (1997) Biologicals , vol.25 , pp. 391-401
    • Cameron, R.1    Davies, J.2    Adcock, W.3    MacGregor, A.4    Barford, J.P.5    Cossart, Y.6    Harbour, C.7
  • 22
    • 84872486143 scopus 로고    scopus 로고
    • Use of sodium hydroxide for cleaning and sanitising chromatography media and systems
    • Application Note 18-1124-57, GE Healthcare Bio-Sciences, Sweden.
    • GE Healthcare. Use of sodium hydroxide for cleaning and sanitising chromatography media and systems. Application Note 18-1124-57, 2009, GE Healthcare Bio-Sciences, Sweden.
    • (2009)
  • 23
    • 0042510543 scopus 로고    scopus 로고
    • Stability of minute virus of mice against temperature and sodium hydroxide
    • Boschetti N, Wyss K, Mischler A, Hostettler T, Kempf C. Stability of minute virus of mice against temperature and sodium hydroxide. Biologicals. 2003;31:181-185.
    • (2003) Biologicals , vol.31 , pp. 181-185
    • Boschetti, N.1    Wyss, K.2    Mischler, A.3    Hostettler, T.4    Kempf, C.5
  • 24
    • 0022382844 scopus 로고
    • Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri (n-butyl) phosphate detergent combinations
    • Horowitz B, Wiebe ME, Lippin A, Stryker MH. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri (n-butyl) phosphate detergent combinations. Transfusion. 1985;25:516-522.
    • (1985) Transfusion , vol.25 , pp. 516-522
    • Horowitz, B.1    Wiebe, M.E.2    Lippin, A.3    Stryker, M.H.4
  • 26
    • 50349084145 scopus 로고    scopus 로고
    • Virus inactivation by solvent/detergent treatment using Triton X-100 in a high purity factor VIII
    • Roberts PL. Virus inactivation by solvent/detergent treatment using Triton X-100 in a high purity factor VIII. Biologicals. 2008;36:330-335.
    • (2008) Biologicals , vol.36 , pp. 330-335
    • Roberts, P.L.1
  • 27
    • 0034003693 scopus 로고    scopus 로고
    • Resistance of vaccinia virus to inactivation by solvent/detergent treatment of blood products
    • Roberts P. Resistance of vaccinia virus to inactivation by solvent/detergent treatment of blood products. Biologicals. 2000;28:29-32.
    • (2000) Biologicals , vol.28 , pp. 29-32
    • Roberts, P.1
  • 28
    • 84893720682 scopus 로고    scopus 로고
    • Enveloped virus inactivation using neutral arginine solutions and application in therapeutic protein purification processes
    • McCue JT, Selvitelli K, Cecchini D, Brown R. Enveloped virus inactivation using neutral arginine solutions and application in therapeutic protein purification processes. Biotechnol Prog. 2014;30:108-112.
    • (2014) Biotechnol Prog , vol.30 , pp. 108-112
    • McCue, J.T.1    Selvitelli, K.2    Cecchini, D.3    Brown, R.4
  • 29
    • 84881612634 scopus 로고    scopus 로고
    • Safety of snake antivenom immunoglobulins. Efficacy of viral inactivation in a complete downstream process
    • Caricati C, Oliveira-Nascimento L, Yoshida J, Caricati A, Raw I, Stephano M. Safety of snake antivenom immunoglobulins. Efficacy of viral inactivation in a complete downstream process. Biotechnol Prog. 2013;29:972-979.
    • (2013) Biotechnol Prog , vol.29 , pp. 972-979
    • Caricati, C.1    Oliveira-Nascimento, L.2    Yoshida, J.3    Caricati, A.4    Raw, I.5    Stephano, M.6
  • 30
    • 0345634644 scopus 로고    scopus 로고
    • An overview of viral filtration in biopharmaceutical manufacturing
    • Carter J, Lutz H. An overview of viral filtration in biopharmaceutical manufacturing. Eur J Parenter Sci. 2002;7:72-78.
    • (2002) Eur J Parenter Sci , vol.7 , pp. 72-78
    • Carter, J.1    Lutz, H.2
  • 31
    • 0003101698 scopus 로고    scopus 로고
    • 1998. Filtration and the removal of viruses from biopharmaceuticals
    • In: Meltzer TH, Jornitz MW, editors. . New York: Marcel Dekker; :-.
    • Levy R, Phillips MW, Lutz H. 1998. Filtration and the removal of viruses from biopharmaceuticals. In: Meltzer TH, Jornitz MW, editors. Filtration in the Biopharmaceutical Industry. New York: Marcel Dekker; 1998:619-646.
    • (1998) Filtration in the Biopharmaceutical Industry , pp. 619-646
    • Levy, R.1    Phillips, M.W.2    Lutz, H.3
  • 33
    • 77649184862 scopus 로고    scopus 로고
    • Application of virus filters to biological products: practical and regulatory considerations
    • Roberts P. Application of virus filters to biological products: practical and regulatory considerations. Eur J Parenter Sci. 2000;5:3-9.
    • (2000) Eur J Parenter Sci , vol.5 , pp. 3-9
    • Roberts, P.1
  • 35
    • 84904054648 scopus 로고    scopus 로고
    • Virus elimination during the recycling of chromatographic columns used during the manufacture of coagulation factors
    • Roberts PL. Virus elimination during the recycling of chromatographic columns used during the manufacture of coagulation factors. Biologicals 2014;42:184-190.
    • (2014) Biologicals , vol.42 , pp. 184-190
    • Roberts, P.L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.