메뉴 건너뛰기




Volumn 29, Issue 4, 2013, Pages 972-979

Safety of snake antivenom immunoglobulins: Efficacy of viral inactivation in a complete downstream process

Author keywords

Antivenom; Immunoglobulin; Phenol; Viral safety

Indexed keywords

ANTIVENOM; CAPRYLIC ACID; DOWNSTREAM PROCESS; IMMUNOGLOBULIN; PHENOL TREATMENT; SAFE PRODUCTS; VIRAL INACTIVATION; VIRAL REDUCTION;

EID: 84881612634     PISSN: 87567938     EISSN: 15206033     Source Type: Journal    
DOI: 10.1002/btpr.1758     Document Type: Article
Times cited : (12)

References (56)
  • 3
    • 84881615230 scopus 로고    scopus 로고
    • WHO. WHO | WHO model lists of essential medicines. WHO. Available at:. Accessed July 11, 2012.
    • WHO. WHO | WHO model lists of essential medicines. WHO. Available at: http://www.who.int/medicines/publications/essentialmedicines/en/. Accessed July 11, 2012.
  • 4
    • 0035206957 scopus 로고    scopus 로고
    • Outcome of intravenous immunoglobulin-transmitted hepatitis C virus infection in primary immunodeficiency
    • Razvi S, Schneider L, Jonas MM, Cunningham-Rundles C. Outcome of intravenous immunoglobulin-transmitted hepatitis C virus infection in primary immunodeficiency. Clin Immunol. 2001;101:284-288.
    • (2001) Clin Immunol. , vol.101 , pp. 284-288
    • Razvi, S.1    Schneider, L.2    Jonas, M.M.3    Cunningham-Rundles, C.4
  • 5
    • 0036750715 scopus 로고    scopus 로고
    • European surveillance of immunoglobulin safety-results of initial survey of 1243 patients with primary immunodeficiencies in 16 countries
    • Quinti I, Pierdominici M, Marziali M, Giovannetti A, Donnanno S, Chapel H, Bjorkander J, Aiuti F. European surveillance of immunoglobulin safety-results of initial survey of 1243 patients with primary immunodeficiencies in 16 countries. Clin Immunol. 2002;104:231-236.
    • (2002) Clin Immunol. , vol.104 , pp. 231-236
    • Quinti, I.1    Pierdominici, M.2    Marziali, M.3    Giovannetti, A.4    Donnanno, S.5    Chapel, H.6    Bjorkander, J.7    Aiuti, F.8
  • 6
    • 19044392885 scopus 로고    scopus 로고
    • Overwhelming course of HCV disease in patients with hypogammaglobulinemia associated with cellular immunity deficiency
    • Carbone J, Sarmiento E, Fernandez Cruz E. Overwhelming course of HCV disease in patients with hypogammaglobulinemia associated with cellular immunity deficiency. Rev Gastroenterol Peru. 2005;25:19-22.
    • (2005) Rev Gastroenterol Peru. , vol.25 , pp. 19-22
    • Carbone, J.1    Sarmiento, E.2    Fernandez Cruz, E.3
  • 7
    • 79957509785 scopus 로고    scopus 로고
    • Antivenoms for the treatment of snakebite envenomings: the road ahead
    • Gutierrez JM, 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
  • 9
    • 0037401660 scopus 로고    scopus 로고
    • Report of a WHO workshop on the standardization and control of antivenoms
    • Theakston RDG, Warrell DA, 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.G.1    Warrell, D.A.2    Griffiths, E.3
  • 10
    • 0342656525 scopus 로고    scopus 로고
    • Viral safety: european and french directives
    • Rossi F, Legras JF. Viral safety: european and french directives. Ann Med Interne (Paris). 2000;151(Suppl 1):1S55-1S61.
    • (2000) Ann Med Interne (Paris). , vol.151 , Issue.SUPPL 1
    • Rossi, F.1    Legras, J.F.2
  • 11
    • 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
  • 12
    • 84858069341 scopus 로고    scopus 로고
    • Low pH formulation of whole IgG antivenom: impact on quality, safety, neutralizing potency and viral inactivation
    • Solano S, Segura Á, León G, Gutiérrez J-M, Burnouf T. Low pH formulation of whole IgG antivenom: impact on quality, safety, neutralizing potency and viral inactivation. Biologicals. 2012;40:129-133.
    • (2012) Biologicals. , vol.40 , pp. 129-133
    • Solano, S.1    Segura, A.2    León, G.3    Gutiérrez, J.-M.4    Burnouf, T.5
  • 13
    • 0028067466 scopus 로고
    • Reduction in virus-neutralizing activity of a bovine colostrum immunoglobulin concentrate by gastric acid and digestive enzymes
    • Petschow BW, Talbott RD. Reduction in virus-neutralizing activity of a bovine colostrum immunoglobulin concentrate by gastric acid and digestive enzymes. J Pediatr Gastroenterol Nutr. 1994;19:228-235.
    • (1994) J Pediatr Gastroenterol Nutr. , vol.19 , pp. 228-235
    • Petschow, B.W.1    Talbott, R.D.2
  • 14
    • 0017514653 scopus 로고
    • Trimmed Spearman-Karber method for estimating median lethal concentrations in toxicity bioassays
    • Hamilton M, Russo R, Thurston R. Trimmed Spearman-Karber method for estimating median lethal concentrations in toxicity bioassays. Environ Sci Technol. 1977;11:714-719.
    • (1977) Environ Sci Technol. , vol.11 , pp. 714-719
    • Hamilton, M.1    Russo, R.2    Thurston, R.3
  • 15
    • 0018848094 scopus 로고
    • Enzyme immunoassay ELISA and EMIT
    • Engvall E. Enzyme immunoassay ELISA and EMIT. Meth Enzymol. 1980;70:419-439.
    • (1980) Meth Enzymol. , vol.70 , pp. 419-439
    • Engvall, E.1
  • 16
    • 0000487421 scopus 로고
    • The action of proteolytic enzymes on the antitoxins and proteins in immune sera: I. True digestion of the proteins
    • Pope CG. The action of proteolytic enzymes on the antitoxins and proteins in immune sera: I. True digestion of the proteins. Br J Exp Pathol. 1939;20:132-149.
    • (1939) Br J Exp Pathol. , vol.20 , pp. 132-149
    • Pope, C.G.1
  • 17
    • 0000487420 scopus 로고
    • The action of proteolytic enzymes on the antitoxins and proteins in immune sera: II. Heat denaturation after partial enzyme action
    • Pope CG. The action of proteolytic enzymes on the antitoxins and proteins in immune sera: II. Heat denaturation after partial enzyme action. Br J Exp Pathol. 1939;20:201-212.
    • (1939) Br J Exp Pathol. , vol.20 , pp. 201-212
    • Pope, C.G.1
  • 18
    • 0342924495 scopus 로고
    • The action of proteolytic enzymes on the antitoxins and proteins in immune sera
    • Pope CG, Stevens MF. The action of proteolytic enzymes on the antitoxins and proteins in immune sera. Br J Exp Pathol. 1951;32:314-324.
    • (1951) Br J Exp Pathol. , vol.32 , pp. 314-324
    • Pope, C.G.1    Stevens, M.F.2
  • 19
    • 0032619059 scopus 로고    scopus 로고
    • Viral validation design of a manufacturing process
    • Larzul D. Viral validation design of a manufacturing process. Dev Biol Stand. 1999;99:139-150.
    • (1999) Dev Biol Stand. , vol.99 , pp. 139-150
    • Larzul, D.1
  • 20
    • 84881611610 scopus 로고    scopus 로고
    • WHO. WHO | WHO guidelines for the production, control and regulation of snake antivenom immunoglobulins. WHO. Available at: Accessed July 11, 2012.
    • WHO. WHO | WHO guidelines for the production, control and regulation of snake antivenom immunoglobulins. WHO. Available at: http://www.who.int/bloodproducts/snake_antivenoms/snakeantivenomguide/en/. Accessed July 11, 2012.
  • 21
    • 0032564029 scopus 로고    scopus 로고
    • Q5A: quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin
    • Guideline, ICH Harmonized Tripartite.
    • Guideline, ICH Harmonized Tripartite. Q5A: quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Fed Reg. 1998; 63:51074.
    • (1998) Fed Reg. , vol.63 , pp. 51074
  • 23
    • 0035808654 scopus 로고    scopus 로고
    • Antibodies against bovine herpesvirus (BHV) 5 may be differentiated from antibodies against BHV1 in a BHV1 glycoprotein E blocking ELISA
    • Wellenberg GJ, Mars MH, Van Oirschot JT. Antibodies against bovine herpesvirus (BHV) 5 may be differentiated from antibodies against BHV1 in a BHV1 glycoprotein E blocking ELISA. Vet Microbiol. 2001;78:79-84.
    • (2001) Vet Microbiol. , vol.78 , pp. 79-84
    • Wellenberg, G.J.1    Mars, M.H.2    Van Oirschot, J.T.3
  • 24
    • 0030139249 scopus 로고    scopus 로고
    • A method for measuring specific antibodies in bovine lacteal secretions during the nonlactating period
    • Guidry AJ, O Brien CN. A method for measuring specific antibodies in bovine lacteal secretions during the nonlactating period. J Dairy Sci. 1996;79:846-850.
    • (1996) J Dairy Sci. , vol.79 , pp. 846-850
    • Guidry, A.J.1    O'Brien, C.N.2
  • 25
    • 0029789189 scopus 로고    scopus 로고
    • A sensitive and specific immunoassay for the measurement of the antibodies present in horse antivenoms endowed with the capacity to block the phospholipase a2-dependent hemolysis induced by snake venoms
    • Campos ACMR, Freitas MCWD, Yamaguchi IK, Marcelino JR, Dias da Silva W. A sensitive and specific immunoassay for the measurement of the antibodies present in horse antivenoms endowed with the capacity to block the phospholipase a2-dependent hemolysis induced by snake venoms. J Venom Anim Toxins. 1996;2:106-120.
    • (1996) J Venom Anim Toxins. , vol.2 , pp. 106-120
    • Campos, A.C.M.R.1    Freitas, M.C.W.D.2    Yamaguchi, I.K.3    Marcelino, J.R.4    Dias da Silva, W.5
  • 26
    • 0026544929 scopus 로고
    • Virus safety of human immunoglobulins: efficient inactivation of hepatitis C and other human pathogenic viruses by the manufacturing procedure
    • Nowak T, Gregersen J-P, Klockmann U, Cummins LB, Hilfenhaus J. Virus safety of human immunoglobulins: efficient inactivation of hepatitis C and other human pathogenic viruses by the manufacturing procedure. J Med Virol. 1992;36:209-216.
    • (1992) J Med Virol. , vol.36 , pp. 209-216
    • Nowak, T.1    Gregersen, J.-P.2    Klockmann, U.3    Cummins, L.B.4    Hilfenhaus, J.5
  • 27
    • 0027459148 scopus 로고
    • Turbidity of hyperimmune equine antivenom: the role of phenol and serum lipoproteins
    • Rojas G, Vargas M, Robles A, Gutiérrez JM. Turbidity of hyperimmune equine antivenom: the role of phenol and serum lipoproteins. Toxicon. 1993;31:61-66.
    • (1993) Toxicon. , vol.31 , pp. 61-66
    • Rojas, G.1    Vargas, M.2    Robles, A.3    Gutiérrez, J.M.4
  • 28
    • 33749253824 scopus 로고    scopus 로고
    • Purification of intravenous immunoglobulin G from human plasma-aspects of yield and virus safety
    • Buchacher A, Iberer G. Purification of intravenous immunoglobulin G from human plasma-aspects of yield and virus safety. Biotechnol J. 2006;1:148-163.
    • (2006) Biotechnol J. , vol.1 , pp. 148-163
    • Buchacher, A.1    Iberer, G.2
  • 29
    • 0031977308 scopus 로고    scopus 로고
    • Characterization and viral safety validation study of a pasteurized therapeutic concentrate of antithrombin III obtained through affinity chromatography
    • Biescas H, Gensana M, Fernández J, Ristol P, Massot M, Watson E, Vericat, F. Characterization and viral safety validation study of a pasteurized therapeutic concentrate of antithrombin III obtained through affinity chromatography. Haematologica. 1998;83:305-311.
    • (1998) Haematologica. , vol.83 , pp. 305-311
    • Biescas, H.1    Gensana, M.2    Fernández, J.3    Ristol, P.4    Massot, M.5    Watson, E.6    Vericat, F.7
  • 30
    • 84881616337 scopus 로고    scopus 로고
    • CPMP. Note for guidance on production and quality control of animal immunoglobulins and immunsera for human use. European Agency for the Evaluation of Medicinal Products (EMEA). Avaiable at: Accessed July 30, 2012.
    • CPMP. Note for guidance on production and quality control of animal immunoglobulins and immunsera for human use. European Agency for the Evaluation of Medicinal Products (EMEA). Avaiable at: http://www.who.int/bloodproducts/publications/EMEA-animal%20sera.pdf. Accessed July 30, 2012.
  • 31
    • 84881617330 scopus 로고    scopus 로고
    • WHO. WHO | Technical report, Series No. 924, 2004, annex 4: guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO. Available at:. Accessed July 11, 2012.
    • WHO. WHO | Technical report, Series No. 924, 2004, annex 4: guidelines on viral inactivation and removal procedures intended to assure the viral safety of human blood plasma products. WHO. Available at: http://www.who.int/bloodproducts/publications/WHO_TRS_924_A4.pdf. Accessed July 11, 2012.
  • 32
    • 0031738447 scopus 로고    scopus 로고
    • Avoiding viral contamination in biotechnological and pharmaceutical processes
    • Henzler H-J, Kaiser K. Avoiding viral contamination in biotechnological and pharmaceutical processes. Nat Biotechnol. 1998;16:1077-1079.
    • (1998) Nat Biotechnol. , vol.16 , pp. 1077-1079
    • Henzler, H.-J.1    Kaiser, K.2
  • 34
    • 44449098092 scopus 로고    scopus 로고
    • Canine coronavirus inactivation with physical and chemical agents
    • Pratelli A. Canine coronavirus inactivation with physical and chemical agents. Vet J. 2008;177:71-79.
    • (2008) Vet J. , vol.177 , pp. 71-79
    • Pratelli, A.1
  • 35
    • 0025975285 scopus 로고
    • Inactivation of lipid-enveloped viruses in proteins by caprylate
    • Lundblad JL, Seng RL. Inactivation of lipid-enveloped viruses in proteins by caprylate. Vox Sang. 1991;60:75-81.
    • (1991) Vox Sang. , vol.60 , pp. 75-81
    • Lundblad, J.L.1    Seng, R.L.2
  • 36
    • 77955270563 scopus 로고    scopus 로고
    • Viral safety characteristics of Flebogamma® DIF, a new pasteurized, solvent-detergent treated and Planova 20 nm nanofiltered intravenous immunoglobulin
    • Caballero S, Nieto S, Gajardo R, Jorquera JI. Viral safety characteristics of Flebogamma® DIF, a new pasteurized, solvent-detergent treated and Planova 20 nm nanofiltered intravenous immunoglobulin. Biologicals. 2010;38:486-493.
    • (2010) Biologicals. , vol.38 , pp. 486-493
    • Caballero, S.1    Nieto, S.2    Gajardo, R.3    Jorquera, J.I.4
  • 37
    • 35248891618 scopus 로고    scopus 로고
    • Partitioning and inactivation of viruses by the caprylic acid precipitation followed by a terminal pasteurization in the manufacturing process of horse immunoglobulins
    • Mpandi M, Schmutz P, Legrand E, Duc R, Geinoz J, Henzelin Nkubana C, Giorgia S, Clerc O, Genoud D, Weber T. Partitioning and inactivation of viruses by the caprylic acid precipitation followed by a terminal pasteurization in the manufacturing process of horse immunoglobulins. Biologicals. 2007;35:335-341.
    • (2007) Biologicals. , vol.35 , pp. 335-341
    • Mpandi, M.1    Schmutz, P.2    Legrand, E.3    Duc, R.4    Geinoz, J.5    Henzelin Nkubana, C.6    Giorgia, S.7    Clerc, O.8    Genoud, D.9    Weber, T.10
  • 38
    • 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 RS, Franks L, Petteway SR Jr. 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 Jr, S.R.6
  • 39
    • 28444469762 scopus 로고    scopus 로고
    • Effect of pepsin digestion on the antivenom activity of equine immunoglobulins
    • Morais V, Massaldi H. Effect of pepsin digestion on the antivenom activity of equine immunoglobulins. Toxicon. 2005;46:876-882.
    • (2005) Toxicon. , vol.46 , pp. 876-882
    • Morais, V.1    Massaldi, H.2
  • 40
    • 0028171409 scopus 로고
    • Inactivation and elimination of viruses during preparation of human intravenous immunoglobulin
    • Uemura Y, Yang YH, Heldebrant CM, Takechi K, Yokoyama K. Inactivation and elimination of viruses during preparation of human intravenous immunoglobulin. Vox Sang. 1994;67:246-254.
    • (1994) Vox Sang. , vol.67 , pp. 246-254
    • Uemura, Y.1    Yang, Y.H.2    Heldebrant, C.M.3    Takechi, K.4    Yokoyama, K.5
  • 41
    • 28644452600 scopus 로고    scopus 로고
    • Antimicrobial biocides in the healthcare environment: efficacy, usage, policies, and perceived problems
    • Maillard J-Y. Antimicrobial biocides in the healthcare environment: efficacy, usage, policies, and perceived problems. Ther Clin Risk Manag. 2005;1:307-320.
    • (2005) Ther Clin Risk Manag. , vol.1 , pp. 307-320
    • Maillard, J.-Y.1
  • 42
    • 84867200989 scopus 로고    scopus 로고
    • Inactivation of enveloped and non-enveloped viruses on seeded human tissues by gamma irradiation
    • Moore MA. Inactivation of enveloped and non-enveloped viruses on seeded human tissues by gamma irradiation. Cell Tissue Bank. 2012;13:401-407.
    • (2012) Cell Tissue Bank. , vol.13 , pp. 401-407
    • Moore, M.A.1
  • 43
    • 0013769452 scopus 로고
    • Inactivation of viruses by benzalkonium chloride
    • Armstrong JA, Froelich EJ. Inactivation of viruses by benzalkonium chloride. Appl Microbiol. 1964;12:132-137.
    • (1964) Appl Microbiol. , vol.12 , pp. 132-137
    • Armstrong, J.A.1    Froelich, E.J.2
  • 44
    • 0013880972 scopus 로고
    • Effect of visible light on canine distemper virus1
    • Nemo GJ, Ernest CC. Effect of visible light on canine distemper virus1. J Bacteriol. 1966;91:798-802.
    • (1966) J Bacteriol. , vol.91 , pp. 798-802
    • Nemo, G.J.1    Ernest, C.C.2
  • 45
    • 0022369833 scopus 로고
    • Rapid inactivation of rotaviruses by exposure to acid buffer or acidic gastric juice
    • Weiss C, Clark HF. Rapid inactivation of rotaviruses by exposure to acid buffer or acidic gastric juice. J Gen Virol. 1985;66(Pt 12):2725-2730.
    • (1985) J Gen Virol. , vol.66 , Issue.PT 12 , pp. 2725-2730
    • Weiss, C.1    Clark, H.F.2
  • 46
    • 0014232135 scopus 로고
    • Morphological studies of a canine adenovirus
    • Yamamoto T, Maruysk RG. Morphological studies of a canine adenovirus. J. Gen. Virol. 1968;2:191-194.
    • (1968) J. Gen. Virol. , vol.2 , pp. 191-194
    • Yamamoto, T.1    Maruysk, R.G.2
  • 47
    • 0014782535 scopus 로고
    • The effect of temperature on the hemagglutinin activity of the canine adenovirus (infectious canine hepatitis virus)
    • Petr G, Jiran E. The effect of temperature on the hemagglutinin activity of the canine adenovirus (infectious canine hepatitis virus). Zentralbl Veterinarmed. 1970;17B:569-581.
    • (1970) Zentralbl Veterinarmed. , vol.17 B , pp. 569-581
    • Petr, G.1    Jiran, E.2
  • 48
    • 0014123408 scopus 로고
    • The effect of ion concentration and pH on the thermal stability of a canine adenovirus
    • Yamamoto T. The effect of ion concentration and pH on the thermal stability of a canine adenovirus. Can J Microbiol. 1967;13:1139-1149.
    • (1967) Can J Microbiol. , vol.13 , pp. 1139-1149
    • Yamamoto, T.1
  • 50
    • 0033769507 scopus 로고    scopus 로고
    • Comparison of the inactivation of canine and bovine parvovirus by freeze-drying and dry-heat treatment in two high purity factor VIII concentrates
    • Roberts PL, Hart H. Comparison of the inactivation of canine and bovine parvovirus by freeze-drying and dry-heat treatment in two high purity factor VIII concentrates. Biologicals. 2000;28:185-188.
    • (2000) Biologicals. , vol.28 , pp. 185-188
    • Roberts, P.L.1    Hart, H.2
  • 52
    • 33847723863 scopus 로고
    • Chemical inactivation of viruses
    • Klein M, Deforest A. Chemical inactivation of viruses. Fed Proc. 1965;24:319.
    • (1965) Fed Proc. , vol.24 , pp. 319
    • Klein, M.1    Deforest, A.2
  • 53
    • 0141456064 scopus 로고    scopus 로고
    • Bovine viral diarrhea virus as a surrogate model of hepatitis C virus for the evaluation of antiviral agents
    • Buckwold VE, Beer BE, Donis RO. Bovine viral diarrhea virus as a surrogate model of hepatitis C virus for the evaluation of antiviral agents. Antiviral Res. 2003;60:1-15.
    • (2003) Antiviral Res. , vol.60 , pp. 1-15
    • Buckwold, V.E.1    Beer, B.E.2    Donis, R.O.3
  • 55
    • 0034884052 scopus 로고    scopus 로고
    • Securing viral safety for plasma derivatives
    • Morgenthaler J-J. Securing viral safety for plasma derivatives. Transfus Med Rev. 2001;15:224-233.
    • (2001) Transfus Med Rev. , vol.15 , pp. 224-233
    • Morgenthaler, J.-J.1
  • 56
    • 0017519818 scopus 로고
    • Inactivation of equine infectious anemia virus by chemical disinfectants
    • Shen DT, Crawford TB, Gorham JR, McGuire TC. Inactivation of equine infectious anemia virus by chemical disinfectants. Am J Vet Res. 1977;38:1217-1219.
    • (1977) Am J Vet Res. , vol.38 , pp. 1217-1219
    • Shen, D.T.1    Crawford, T.B.2    Gorham, J.R.3    McGuire, T.C.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.