메뉴 건너뛰기




Volumn 40, Issue 2, 2012, Pages 129-133

Low pH formulation of whole IgG antivenom: Impact on quality, safety, neutralizing potency and viral inactivation

Author keywords

Antivenom; Inactivation; Low pH; Virus

Indexed keywords

IMMUNOGLOBULIN; IMMUNOGLOBULIN G; OCTANOIC ACID; SORBITOL;

EID: 84858069341     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.11.006     Document Type: Article
Times cited : (17)

References (36)
  • 1
    • 56949102212 scopus 로고    scopus 로고
    • Preparation and use of therapeutic antibodies primarily of human origin
    • Stiehm E.R., Keller M.A., Vyas G.N. Preparation and use of therapeutic antibodies primarily of human origin. Biologicals 2008, 36:363-374.
    • (2008) Biologicals , vol.36 , pp. 363-374
    • Stiehm, E.R.1    Keller, M.A.2    Vyas, G.N.3
  • 2
    • 78650355088 scopus 로고    scopus 로고
    • Recombinant plasma proteins
    • Burnouf T. Recombinant plasma proteins. Vox Sang 2011, 100:68-83.
    • (2011) Vox Sang , vol.100 , pp. 68-83
    • Burnouf, T.1
  • 5
    • 79957509785 scopus 로고    scopus 로고
    • Antivenoms for the treatment of snakebite envenomings: the road ahead
    • Gutierrez J.M., Leon G., Burnouf T. Antivenoms for the treatment of snakebite envenomings: the road ahead. Biologicals 2011, 39:129-142.
    • (2011) Biologicals , vol.39 , pp. 129-142
    • Gutierrez, J.M.1    Leon, G.2    Burnouf, T.3
  • 6
    • 0031803535 scopus 로고    scopus 로고
    • Venoms, antivenoms and immunotherapy
    • Chippaux J.P., Goyffon M. Venoms, antivenoms and immunotherapy. Toxicon 1998, 36:823-846.
    • (1998) Toxicon , vol.36 , pp. 823-846
    • Chippaux, J.P.1    Goyffon, M.2
  • 7
    • 0037401660 scopus 로고    scopus 로고
    • Report of a WHO workshop on the standardization and control of antivenoms
    • Theakston R.D., Warrell D.A., Griffiths E. Report of a WHO workshop on the standardization and control of antivenoms. Toxicon 2003, 41:541-557.
    • (2003) Toxicon , vol.41 , pp. 541-557
    • Theakston, R.D.1    Warrell, D.A.2    Griffiths, E.3
  • 10
    • 33745617121 scopus 로고    scopus 로고
    • Confronting the neglected problem of snake bite envenoming: the need for a global partnership
    • Gutierrez J.M., Theakston R.D., Warrell D.A. Confronting the neglected problem of snake bite envenoming: the need for a global partnership. PLoS Med 2006, 3:e150.
    • (2006) PLoS Med , vol.3
    • Gutierrez, J.M.1    Theakston, R.D.2    Warrell, D.A.3
  • 11
    • 0002606355 scopus 로고    scopus 로고
    • Preparation of improved F(ab')2 antivenoms. An example: new polyvalent European viper antivenom (equine)
    • Fondation Marcel Mérieux, Lyon, C. Bon, M. Goyffon (Eds.)
    • Grandgeorge M., Véron J.L., Lutsch C., Makula M.F., Riffard P., Pépin S., et al. Preparation of improved F(ab')2 antivenoms. An example: new polyvalent European viper antivenom (equine). Envenomings and their treatments 1996, 161-172. Fondation Marcel Mérieux, Lyon. C. Bon, M. Goyffon (Eds.).
    • (1996) Envenomings and their treatments , pp. 161-172
    • Grandgeorge, M.1    Véron, J.L.2    Lutsch, C.3    Makula, M.F.4    Riffard, P.5    Pépin, S.6
  • 12
    • 35348923046 scopus 로고    scopus 로고
    • Practical experience with the use of Planova 15N in the manufacture of FDA approved products
    • Asahi kasei, Lisbon, Portugal
    • Denton A. Practical experience with the use of Planova 15N in the manufacture of FDA approved products. 7th Planova workshop 2004 in Europe 2004, Asahi kasei, Lisbon, Portugal.
    • (2004) 7th Planova workshop 2004 in Europe
    • Denton, A.1
  • 15
    • 73649119908 scopus 로고    scopus 로고
    • Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance
    • Radosevich M., Burnouf T. Intravenous immunoglobulin G: trends in production methods, quality control and quality assurance. Vox Sang 2010, 98:12-28.
    • (2010) Vox Sang , vol.98 , pp. 12-28
    • Radosevich, M.1    Burnouf, T.2
  • 16
    • 0028295746 scopus 로고
    • Caprylic acid fractionation of hyperimmune horse plasma: description of a simple procedure for antivenom production
    • Rojas G., Jimenez J.M., Gutierrez J.M. Caprylic acid fractionation of hyperimmune horse plasma: description of a simple procedure for antivenom production. Toxicon 1994, 32:351-363.
    • (1994) Toxicon , vol.32 , pp. 351-363
    • Rojas, G.1    Jimenez, J.M.2    Gutierrez, J.M.3
  • 17
    • 0031023402 scopus 로고    scopus 로고
    • Clinical and laboratory alterations in horses during immunization with snake venoms for the production of polyvalent (Crotalinae) antivenom
    • Angulo Y., Estrada R., Gutierrez J.M. Clinical and laboratory alterations in horses during immunization with snake venoms for the production of polyvalent (Crotalinae) antivenom. Toxicon 1997, 35:81-90.
    • (1997) Toxicon , vol.35 , pp. 81-90
    • Angulo, Y.1    Estrada, R.2    Gutierrez, J.M.3
  • 18
    • 69649102234 scopus 로고    scopus 로고
    • Assessment of the impact of solvent/detergent treatment on the quality and potency of a whole IgG equine antivenom
    • Segura A., Leon G., Su C.Y., Gutierrez J.M., Burnouf T. Assessment of the impact of solvent/detergent treatment on the quality and potency of a whole IgG equine antivenom. Biologicals 2009, 37:306-312.
    • (2009) Biologicals , vol.37 , pp. 306-312
    • Segura, A.1    Leon, G.2    Su, C.Y.3    Gutierrez, J.M.4    Burnouf, T.5
  • 19
    • 0025048405 scopus 로고
    • Standardization of assays for testing the neutralizing ability of antivenoms
    • author reply 9-32
    • Gutiérrez J.M., Rojas G., Lomonte B., Gene J.A., Chaves F., Alvarado J., et al. Standardization of assays for testing the neutralizing ability of antivenoms. Toxicon 1990, 28:1127-1129. author reply 9-32.
    • (1990) Toxicon , vol.28 , pp. 1127-1129
    • Gutiérrez, J.M.1    Rojas, G.2    Lomonte, B.3    Gene, J.A.4    Chaves, F.5    Alvarado, J.6
  • 22
    • 33846666175 scopus 로고    scopus 로고
    • Modern plasma fractionation
    • Burnouf T. Modern plasma fractionation. Transfus Med Rev 2007, 21:101-117.
    • (2007) Transfus Med Rev , vol.21 , pp. 101-117
    • Burnouf, T.1
  • 23
    • 0033859810 scopus 로고    scopus 로고
    • Reducing the risk of infection from plasma products: specific preventative strategies
    • Burnouf T., Radosevich M. Reducing the risk of infection from plasma products: specific preventative strategies. Blood Rev 2000, 14:94-110.
    • (2000) Blood Rev , vol.14 , pp. 94-110
    • Burnouf, T.1    Radosevich, M.2
  • 24
    • 0022747546 scopus 로고
    • Three generations of immunoglobulin G preparations for clinical use
    • McCue J.P., Hein R.H., Tenold R. Three generations of immunoglobulin G preparations for clinical use. Rev Infect Dis 1986, 8(Suppl 4):S374-S381.
    • (1986) Rev Infect Dis , vol.8 , Issue.SUPPL. 4
    • McCue, J.P.1    Hein, R.H.2    Tenold, R.3
  • 25
    • 53649100150 scopus 로고    scopus 로고
    • Intravenous immunoglobulins: evolution of commercial IVIG preparations
    • viii
    • Hooper J.A. Intravenous immunoglobulins: evolution of commercial IVIG preparations. Immunol Allergy Clin North Am 2008, 28:765-778. viii.
    • (2008) Immunol Allergy Clin North Am , vol.28 , pp. 765-778
    • Hooper, J.A.1
  • 26
    • 0028304289 scopus 로고
    • Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action
    • Schiff R.I. Intravenous gammaglobulin: pharmacology, clinical uses and mechanisms of action. Pediatr Allergy Immunol 1994, 5:63-87.
    • (1994) Pediatr Allergy Immunol , vol.5 , pp. 63-87
    • Schiff, R.I.1
  • 27
    • 0029801029 scopus 로고    scopus 로고
    • Virus inactivation by pepsin treatment at pH 4 of IgG solutions: factors affecting the rate of virus inactivation
    • Omar A., Kempf C., Immelmann A., Rentsch M., Morgenthaler J.J. Virus inactivation by pepsin treatment at pH 4 of IgG solutions: factors affecting the rate of virus inactivation. Transfusion 1996, 36:866-872.
    • (1996) Transfusion , vol.36 , pp. 866-872
    • Omar, A.1    Kempf, C.2    Immelmann, A.3    Rentsch, M.4    Morgenthaler, J.J.5
  • 28
    • 0029759522 scopus 로고    scopus 로고
    • Virus validation studies of immunoglobulin preparations
    • Biesert L. Virus validation studies of immunoglobulin preparations. Clin Exp Rheumatol 1996, 14(Suppl. 15):S47-S52.
    • (1996) Clin Exp Rheumatol , vol.14 , Issue.SUPPL. 15
    • Biesert, L.1
  • 29
    • 0023751812 scopus 로고
    • Potential contribution of mild pepsin treatment at pH4 to the viral safety of human immunoglobulin products
    • Reid K.G., Cuthbertson B., Jones A.D., McIntosh R.V. Potential contribution of mild pepsin treatment at pH4 to the viral safety of human immunoglobulin products. Vox Sang 1988, 55:75-80.
    • (1988) Vox Sang , vol.55 , pp. 75-80
    • Reid, K.G.1    Cuthbertson, B.2    Jones, A.D.3    McIntosh, R.V.4
  • 30
    • 0032466643 scopus 로고    scopus 로고
    • Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process
    • Bos O.J., Sunye D.G., Nieuweboer C.E., van Engelenburg F.A., Schuitemaker H., Over J. Virus validation of pH 4-treated human immunoglobulin products produced by the Cohn fractionation process. Biologicals 1998, 26:267-276.
    • (1998) Biologicals , vol.26 , pp. 267-276
    • Bos, O.J.1    Sunye, D.G.2    Nieuweboer, C.E.3    van Engelenburg, F.A.4    Schuitemaker, H.5    Over, J.6
  • 31
    • 0028260613 scopus 로고
    • Inactivation of hepatitis C virus in low pH intravenous immunoglobulin
    • Louie R.E., Galloway C.J., Dumas M.L., Wong M.F., Mitra G. Inactivation of hepatitis C virus in low pH intravenous immunoglobulin. Biologicals 1994, 22:13-19.
    • (1994) Biologicals , vol.22 , pp. 13-19
    • Louie, R.E.1    Galloway, C.J.2    Dumas, M.L.3    Wong, M.F.4    Mitra, G.5
  • 32
    • 40749088877 scopus 로고    scopus 로고
    • A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity
    • Poelsler G., Berting A., Kindermann J., Spruth M., Hammerle T., Teschner W., et al. A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity. Vox Sang 2008, 94:184-192.
    • (2008) Vox Sang , vol.94 , pp. 184-192
    • Poelsler, G.1    Berting, A.2    Kindermann, J.3    Spruth, M.4    Hammerle, T.5    Teschner, W.6
  • 34
    • 35348898600 scopus 로고    scopus 로고
    • Assessment of viral inactivation during pH 3.3 pepsin digestion and caprylic acid treatment of antivenoms
    • Burnouf T., Terpstra F., Habib G., Seddik S. Assessment of viral inactivation during pH 3.3 pepsin digestion and caprylic acid treatment of antivenoms. Biologicals 2007, 35:329-334.
    • (2007) Biologicals , vol.35 , pp. 329-334
    • Burnouf, T.1    Terpstra, F.2    Habib, G.3    Seddik, S.4
  • 35
    • 0036628384 scopus 로고    scopus 로고
    • Inactivation of lipid enveloped viruses by octanoic acid treatment of immunoglobulin solution
    • Dichtelmuller H., Rudnick D., Kloft M. Inactivation of lipid enveloped viruses by octanoic acid treatment of immunoglobulin solution. Biologicals 2002, 30:135-142.
    • (2002) Biologicals , vol.30 , pp. 135-142
    • Dichtelmuller, H.1    Rudnick, D.2    Kloft, M.3
  • 36
    • 0036628331 scopus 로고    scopus 로고
    • Enveloped virus inactivation by caprylate: a robust alternative to solvent-detergent treatment in plasma derived intermediates
    • Korneyeva M., Hotta J., Lebing W., Rosenthal R.S., Franks L., Petteway S.R. Enveloped virus inactivation by caprylate: a robust alternative to solvent-detergent treatment in plasma derived intermediates. Biologicals 2002, 30:153-162.
    • (2002) Biologicals , vol.30 , pp. 153-162
    • Korneyeva, M.1    Hotta, J.2    Lebing, W.3    Rosenthal, R.S.4    Franks, L.5    Petteway, S.R.6


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.