Pathogen inactivation and removal procedures used in the production of intravenous immunoglobulins

Biologicals

Volumn 35, Issue 1, 2007, Pages 35-42

  Kempf, Christoph ^a,b   Stucki, Martin ^a   Boschetti, Nicola ^a  

^a ZLB Behring AG   (Switzerland)

^b UNIVERSITY OF BERN   (Switzerland)

Author keywords

Biotechnology; Blood; IVIG; Plasma; Safety

Indexed keywords

CARIMUNE NF; IMMUNOGLOBULIN; UNCLASSIFIED DRUG;

ARTICLE; AUTOIMMUNE DISEASE; DRUG MANUFACTURE; DRUG MECHANISM; DRUG SAFETY; HUMAN; IMMUNE DEFICIENCY; IMMUNOGLOBULIN PRODUCTION; NONHUMAN; PATHOGENESIS; PLASMA; PRIORITY JOURNAL; SINGLE DRUG DOSE; VIRUS INACTIVATION; VIRUS INFECTION;

AUTOIMMUNE DISEASES; DRUG CONTAMINATION; HEAT; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; PLASMA; PRION DISEASES; PRIONS; SEVERE COMBINED IMMUNODEFICIENCY; VIRAL LOAD; VIRUS INACTIVATION; VIRUSES;

EID: 33847174630     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2006.01.002     Document Type: Article

References (66)

1. Imbach P., Barandun S., d'Apuzzo V., Baumgartner C., Hirt A., Morell A., et al. High-dose intravenous gammaglobulin for idiopathic thrombocytopenic purpura in childhood. Lancet 1 (1981) 1228-1231
2. Gelfand E.W. Use of IGIV in the treatment of immune-mediated dermatologic disorders. J Investig Dermatol Symp Proc 9 (2004) 92-96
3. Dalakas M.C. Intravenous immunoglobulin in autoimmune neuromuscular diseases. JAMA 291 (2004) 2367-2375
4. Simon H.U., and Späth P.J. IVIG - mechanisms of action. Allergy 58 (2003) 543-552
5. Bayry J., Misra N., Latry V., Prost F., Delignat S., Lacroix-Desmazes S., et al. Mechanisms of action of intravenous immunoglobulin in autoimmune and inflammatory diseases. Transfus Clin Biol 10 (2003) 165-169
6. Gellis S.S., Neefe J.R., and Stokes J. Chemical, clinical and immunological studies on the products of human plasma fractionation. XXXVI. Inactivation of the virus of homologous serum hepatitis in the solutions of normal human serum by means of heat. J Clin Invest 27 (1948) 239-244
7. Gerety R.J., and Aronson D.L. Plasma derivatives and viral hepatitis. Transfusion 22 (1982) 347-351
8. Lane R.S. Non-A, non-B hepatitis from intravenous immunoglobulin. Lancet II (1983) 974-975
9. Barré-Sinoussi F., Chermann J.C., Rey F., Nugeyre M.T., Chamaret S., Gruest J., et al. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Science 220 (1983) 868-871
10. Centers of disease control. Provisional public health service interagency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome. MMWR 34 (1985) 1-4
11. Ochs H.D., Fisher S.H., Virant F.S., Lee M.L., Mankarious S., Kingdon H.S., et al. Non-A, non-B hepatitis after intravenous gammaglobulin. Lancet 1 (1986) 322-323
12. Bjoerkander J., Rundles C.C., Lundin P., Olsson R., Soederstroem R., and Hanson L.A. Intravenous immunoglobulin prophylaxis causing liver damage in 16 of 77 patients with hypogammaglobulinemia or IgG subclass deficiency. Am J Med 84 (1988) 107-111
13. Prince A.M., Stephan W., Dichtelmuller H., Brotman B., and Huima T. Inactivation of the Hutchinson strain of non-A, non-B hepatitis virus by combined use of beta-propiolactone and ultraviolet irradiation. J Med Virol 16 (1985) 119-125
14. Piszkiewicz D., Kingdom H., Apfelzweig R., McDougal J.S., Cort S.P., Andrews J., et al. Inactivation of HTLV-III/LAV during plasma fractionation. Lancet 2 (1985) 1188-1189
15. Wells M.A., Wittek A.E., Epstein J.S., Sekura C.M., Daniel S., Tankersley D.L., et al. Inactivation and partition of human T-cell lymphotrophic virus, type III, during ethanol fractionation of plasma. Transfusion 26 (1986) 210-213
16. Mitra G., Wong M.F., Mozen M.M., and Levy J.A. Elimination of infectious retroviruses during preparation of immunoglobulins. Transfusion 26 (1986) 394-397
17. Henin Y., Marechal V., Sinouissi F.B., Chermann J.C., and Morgenthaler J.-J. Inactivation and partition of human immunodeficiency virus during Kistler and Nitschmann fractionation of human blood plasma. Vox Sang 54 (1988) 78-83
18. Yei S., Yu M.W., and Tankersley D.L. Partitioning of hepatitis-C virus during Cohn-Oncley fractionation of plasma. Transfusion 32 (1992) 824-828
19. Louie R.E., Galloway C.J., Dumas M.L., Wong M.F., and Mitra G. Inactivation of hepatitis C virus in low pH intravenous immunoglobulin. Biologicals 22 (1994) 13-19
20. Reid K.G., Cuthbertson B., Jones A.D.L., and McIntosh R.V. Potential contribution of mild pepsin treatment at pH 4 to the viral safety of human immunoglobulin products. Vox Sang 55 (1988) 75-80
21. Kempf C., Jentsch P., Poirier B., Sinoussi F.B., Morgenthaler J.-J., Morell A., et al. Virus inactivation during production of intravenous immunoglobulin. Transfusion 31 (1991) 423-427
22. Hamamoto Y., Harada S., Yamamoto N., Uemura Y., Goto T., and Suyama T. Elimination of viruses (human immundeficiency, hepatitis B, vesicular stomatitis and sindbis viruses) from an intravenous immunoglobulin preparation. Vox Sang 53 (1987) 65-69
23. Horowitz B. Preparation of virus sterilized immune globulin solutions by treatment with organic solvent/detergent mixtures. In: Krijnen H.W., Strengers P.F.W., and van Aken W.G. (Eds). Proceeding of an international symposium (1988), Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam 285-295
24. Funakoshi S., Uemura Y., and Yamamoto N. Virus inactivation and elimination by liquid heat treatment and PEG fractionation in the manufacture of immune globulin intravenous. In: Krijnen H.W., Strengers P.F.W., and van Aken W.G. (Eds). Proceeding of an international symposium (1988), Central Laboratory of the Netherlands Red Cross Blood Transfusion Service, Amsterdam 313-325
25. Sofer G., Brorson K., Abujoub A., Aranha H., Burnouf T., Carter J., et al. Virus filtration. PDA J Pharm Sci Technol 59 (2005) 9-42
26. Gürtler L. Blood-borne viral infections. Blood Coagul Fibrinolysis 5 Suppl. 3 (1994) S5-S12
27. Alter H.J., Holland P.V., Purcell R.H., and Gerin J.L. The Ausria test: critical evaluation of sensitivity and specificity. Blood 42 (1973) 947-957
28. Sarngadharan M.G., Popovic M., Bruch L., Schupbach J., and Gallo R.C. Antibodies reactive with human T-lymphotropic retroviruses (HTLV-III) in the serum of patients with AIDS. Science 224 (1984) 506-508
29. Kuo G., Choo Q.L., Alter H.J., Gitnick G.L., Redeker A.G., Purcell R.H., et al. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science 244 (1989) 362-364
30. Committee for proprietary medicinal products (CPMP). Note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95; 1996.
31. Dixon M., and Webb E.C. Enzyme isolation: methods of purification. In: Dixon M., and Webb E.C. (Eds) (1964), Academic Press, New York 36-37
32. Hollinger F.B., Dolana G., Thomas W., and Gyorkey F. Reduction in risk of hepatitis transmission by heat-treatment of a human Factor VIII concentrate. J Infect Dis 150 (1984) 250-262
33. Colvin B.T., Rizza C.R., Hill F.G.H., Kernoff P.B.A., Bateman C.J.T., Bolton-Maggs P., et al. Effect of dry-heating of coagulation factor concentrates at 80 degrees C for 72 hours on transmission of non-A, non-B hepatitis. Study group of the UK haemophilia centre directors on surveillance of virus transmission by concentrates. Lancet 2 (1988) 814-816
34. Uemura Y., Yang Y.H.J., Heldebrant C.M., Takechi K., and Yokoyama K. Inactivation and elimination of viruses during preparation of human intravenous immunoglobulin. Vox Sang 67 (1994) 246-254
35. Chandra S., Cavanaugh J.E., Lin C.M., Pierre-Jerome C., Yerram N., Weeks R., et al. Virus reduction in the preparation of intravenous immune globulin: in vitro experiments. Transfusion 39 (1999) 249-257
36. Chandra S., Gröner A., and Feldman F. Effectiveness of alternative treatments for reducing potential viral contaminants from plasma-derived products. Thromb Res 105 (2002) 391-400
37. The lipids. In: White A., Handler P., and Smith E. (Eds) (1978), McGraw-Hill, New York 45
38. Boschetti N., Niederhauser I., Kempf C., Stühler A., Löwer J., and Blümel J. Different susceptibility of B19 virus and minute virus of mice to low pH treatment. Transfusion 44 (2004) 1079-1086
39. Horowitz B., Wiebe M.E., Lippin A., and Stryker M.H. Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri(n-butyl)phosphate detergent combinations. Transfusion 25 (1985) 516-522
40. Lebing W., Remington K.M., Schreiner C., and Paul H.I. Properties of a new intravenous immunoglobulin (IGIV-C, 10%) produced by virus inactivation with caprylate and column chromatography. Vox Sang 84 (2003) 193-201
41. Burnouf-Radosevich M., Appourchaux P., Huart J.J., and Burnouf T. Nanofiltration, a new specific virus elimination method applied to high-purity factor IX and factor XI concentrates. Vox Sang 67 (1994) 132-138
42. O'Grady J., Losikoff A., Poiley J., Fickett D., and Oliver C. Virus removal studies using nanofiltration membranes. Dev Biol Stand 88 (1996) 319-326
43. Troccoli N.M., McIver J., Losikoff A., and Poiley J. Removal of viruses from human intravenous immune globulin by 35 nm nanofiltration. Biologicals 26 (1998) 321-329
44. Dichtelmüller D. Nanofiltration of IgG-solution. Planova Workshop (2001) 39-49
45. Van Holten R.W., Ciavarella D., Oulundsen G., Harmon F., and Riester S. Incorporation of an additional viral-clearance step into a human immunoglobulin manufacturing process. Vox Sang 83 (2002) 227-233
46. Omar A., and Kempf C. Removal of neutralized model parvoviruses and enteroviruses in human IgG solutions by nanofiltration. Transfusion 42 (2002) 1005-1010
47. Chesebro B., and Fields B.N. Transmissible spongiform encephalopathies: a brief introduction. 3rd ed. In: Fields B.N., Knipe D.M., and Howley P.M. (Eds) (1996), Lippincott-Raven, Philadelphia 2845-2849
48. Brown P., Cervenakova L., McShane L.M., Barber P., Rubenstein R., and Drohan W.N. Further studies of blood infectivity in an experimental model of transmissible spongiform encephalopathy, with an explanation of why blood components do not transmit Creutzfeldt-Jakob disease in humans. Transfusion 39 (1999) 1169-1178
49. Hunter N., Foster J., Chong A., McCutcheon S., Parnham D., Eaton S., et al. Transmission of prion diseases by blood transfusion. J Gen Virol 83 (2002) 2897-2905
50. Herzog C., Sales N., Etchegaray N., Charbonnier A., Freire S., Dormont D., et al. Tissue distribution of bovine spongiform encephalopathy agent in primates after intravenous or oral infection. Lancet 363 (2004) 422-428
51. Gregori L., Maring J.-A., McAuley C., Dunston B., Kempf C., Rentsch M., et al. Partitioning of TSE infectivity during ethanol fractionation of human plasma. Biologicals 32 (2004) 1-10
52. Trejo S.R., Hotta J.A., Lebing W., Stenland C., Storms R.E., Lee D.C., et al. Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 84 (2003) 176-187
53. Van Holten R.W., and Autenrieth S.M. Evaluation of depth filtration to remove prion challenge from an immune globulin preparation. Vox Sang 85 (2003) 20-24
54. Tateishi J., Kitamoto T., Mohri S., Satoh S., Sato T., Shepherd A., et al. Scrapie removal using Planova virus removal filters. Biologicals 29 (2002) 17-25
55. Centers of disease control. Revised US surveillance case definition for severe acute respiratory syndrome (SARS) and update on SARS Cases - United States and Worldwide, December. MMWR 52 (2003) 1202-1206
56. Centers of disease control. Detection of west Nile virus in blood donations - United States. MMWR 52 (2003) 769-772
57. Ng L.F., Wong M., Koh S., Ooi E.-E., Tang K.-F., Leong H.N., et al. Detection of severe acute respiratory syndrome coronavirus in blood of infected patients. J Clin Microbiol 42 (2004) 347-350
58. Holmes K.V., and Lai M.M.C. Coronoviridae: the viruses and their replication. 3rd ed. In: Fields B.N., Knipe D.M., and Howley P.M. (Eds) (1996), Lippincott-Raven, Philadelphia 1075-1093
59. Center for biologics evaluation and research (CBER). Guidance for industry: revised recommendations for the assessment of donor suitability and blood and blood product safety in cases of known or suspected west Nile virus infection: final guidance (2003), U.S. Department of Health and Human Services, Food and Drug Administration, Rockville, MD
60. Käsermann F., Kempf C., and Boschetti N. Strengths and limitations of the model virus concept. PDA J Pharm Sci Technol 58 (2004) 244-249
61. Kreil T.R., Berting A., Kistner O., and Kindermann J. West Nile virus and the safety of plasma derivatives: verification of high safety margins, and the validity of predictions based on model virus data. Transfusion 43 (2003) 1023-1028
62. Schroeder D.D., and Mozen M.M. Australia antigen: distribution during Cohn ethanol fractionation of human plasma. Science 168 (1970) 1462-1464
63. Bayer AG. Promotional Brochure, Polyglobin 5%; 1997.
64. Baxter healthcare corporation prescribing information, Gammagard S/D 2002.
65. Aventis behring prescribing information, Gammar P IV 2001.
66. Kempf C., Morgenthaler J.-J., Rentsch M., and Omar A. In: Kazatchkine M.D., and Morell A. (Eds). Viral safety and manufacturing of an intravenous immunoglobulin (1996), The Parthenon Publishing Group, New York; London 11-18