Viral Clearance Strategies for Biopharmaceutical Safety: Part I: General Considerations

Pharmaceutical Technology

Volumn 25, Issue 4, 2001, Pages 22-91

  Aranha, Hazel ^a  

^a PALL CORPORATION   (United States)

Author keywords

[No Author keywords available]

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EID: 0041875188     PISSN: 01478087     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (76)

1. "Biotech Boom," Chem. Week 161 (10), 27 (1999).
2. Biotechnology Industry Organization, at the BIO 2000 conference, Boston, 26-30 March 2000.
3. The Introduction of Nucleic Acid Amplification Technology (NAT) Testing for the Detection of Hepatitis C Virus RNA in Plasma Pools: Addendum to Note for Guidance on Plasma-Derived Medicinal Products (CPMP/BWP/269/95) (CPMP/BWP/390/97), March 1998.
4. Note for Guidance on Plasma-Derived Medicinal Products Rev. 2 (CPMP/BWP/269/95), July 1998.
5. N. Nathanson and A.D. Langmuir, "The Cutter Incident: Poliomyelitis Following Formaldehyde-Inactivated Poliovirus Vaccination in the United States During the Spring of 1955: Part II -Relationship of Poliomyelitis to Cutter Vaccine," Am. J. Epidemiol. 142, 109-140 (1963).
6. M. Para, "An Outbreak of Post-Vaccinal Rabies (Rage de Laboratorie) in Fortaleza, Brazil, in 1960: Residual Fixed Virus as the Etiological Agent," Bull. World Health Organ. 33, 177-182 (1965).
7. A.M. King et al., "Biochemical Identification of Viruses Causing the 1981 Outbreaks of Foot and Mouth Disease in the UK," Nature 293, 479-480 (1981).
8. K. Shah and N. Nathanson, "Human Exposure to SV40: Review and Comment," Am. J. Epidemiol. 103, 1-12 (1976).
9. R.J.C. Harris et al., "Contaminant Viruses in Two Live Virus Vaccines Produced in Chick Cells," J. Hyg. (Cambridge) 64, 1-6 (1966).
10. G.S. Wilson, The Hazards of Immunization (The Athlone Press, London, 1967).
11. H.D. Strickler and J.J. Goedert, "Exposure to SV40-Contaminated Poliovirus Vaccine and the Risk of Cancer: A Review of the Epidemiological Evidence," Dev. Biol. Stand. 94, 235-244 (1998).
12. E. Aygoren-Pursun and I. Scharrer, "A Multicenter Pharmacosurveillance Study for the Evaluation of the Efficacy and Safety of Recombinant Factor VIII in the Treatment of Patients with Hemophilia A. German Kogenate Study Group," Thromb. Haemost. 78, 1352-1356 (1997).
13. A.M. Eis-Hubinger, U. Sasowski, and H.H. Brackmann, "Parvovirus B19 Contamination in Coagulation Factor VIII Products," Thromb. Haemost. 81, 476-477 (1999).
14. M. Chudey et al., "A New Cluster of Hepatitis A Infection in Hemophiliacs Traced to a Contaminated Plasma Pool," J. Med. Virol. 57, 91-99 (1999).
15. S.C. Darby et al., "Mortality Before and After HIV Infection in the Complete UK Population of Haemophiliacs," Nature 377, 79-82 (1995).
16. E. Santagostino et al., "Transmission of Parvovirus B19 by Coagulation Factor Concentrates Exposed to 100 °C Heat after Lyophilization," Transfusion 37, 517-522 (1997).
17. G.B. Schreiber et al., "The Risk of Transfusion-Transmitted Viral Infections," N. Engl. J. Med. 334, 1685-1690 (1996).
18. Y.J. Wang et al., "Incidence of Post-Transfusion Hepatitis Before and After Screening for Hepatitis C Virus Antibody," Vox. Sang. 67, 187-190 (1994).
19. H. Willkommen, I. Schmidt, and J. Lower, "Safety Issues for Plasma Derivatives and Benefit from NAT Testing," Biologicals 27, 325-331 (1999).
20. H. Rabenau et al., "Contamination of Genetically Engineered CHO-Cells by Epizootic Haemorrhagic Disease Virus (EHDV)," Biologicals 21, 207-214 (1993).
21. R.L. Garnick, "Experience with Viral Contamination in Cell Culture," Dev. Biol. Stand. 88, 49-56 (1996).
22. Center for Biologies Evaluation and Research, Voluntary Recall of Pooled Plasma, Solvent Detergent Treated PLAS+ SD (FDA, Rockville, MD), April 1999.
23. J. Hilfenhaus et al., "Analysis of Human Plasma Products: Polymerase Chain Reaction Does Not Discriminate Between Live and Inactivated Virus," Transfusion 37, 935-940 (1997).
24. P. Castle and J.S. Robertson, "Animal Sera, Animal Sera Derivatives and Substitutes Used in the Manufacture of Pharmaceuticals," Biologicals 26, 365-368 (1998).
25. 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), February 1996.
26. "Guidance on Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin," Federal Register 63 (185), 51074-51084 (1998).
27. H. Aranha-Creado, "Ensuring Safety of Biologicals: Virus Removal from Biological Fluids by Filtration," in Biotechnology: Issues in Quality Assurance and Validation, K. Avis and C. Wagner, Eds. (Interpharm Press, Chicago, 1998).
28. H. Aranha-Creado, J. Peterson, and P.Y. Huang, "Clearance of Murine Leukaemia Virus from Monoclonal Antibody Solutions by a Hydrophilic PVDF Microporous Membrane Filter," Biologicals 26, 167-172 (1998).
29. "Note for Guidance, Validation of Virus Removal and Inactivation Procedures: EEC Regulatory Document," Biologicals 19, 247-251 (1991).
30. C.J. Marcus-Sekura, "Validation of Removal of Human Retroviruses," Dev. Biol. Stand. 76, 215-223 (1992).
31. P.J. Shadle et al., "Viral Validation Strategy for Recombinant Products Derived from Established Animal Cell Lines," Cytotechnol. 18, 21-25 (1995).
32. Federal Register 63, Section VI-C, 51074-51084 (1998).
33. E. Hamatainen, H. Suomela, and P. Ukkonen, "Virus Inactivation During Intravenous Immunoglobulin Production," Vox. Sang. 63, 6-11 (1992).
34. J.B. Grun, E.M. White, and A.F. Sito, "Viral Removal/Inactivation by Purification of Biopharmaceuticals," BioPharm 5 (9), 22-30 (1992).
35. B. Horowitz and M.S. Horowitz, "Human Leukocyte Alpha-Interferon Preparations: Laboratory Characterization and Evaluation of Clinical Safety," in Interferon: Research, Clinical Applications and Regulatory Considerations, K.C. Zoon, P.P. Noguchi, and T.Y. Lie, Eds. (Elsevier Science Publishing Co., Inc., New York, 1984), pp. 41-53.
36. H. Aranha-Creado et al., "Virus Retention by a Hydrophilic Triple-Layer PVDF Microporous Membrane Filter," PDA J. Pharm. Sci. Technol. 51, 119-124 (1997).
37. A.J. DiLeo, D.A. Vacante, and E. Deane, "Size Exclusion Removal of Model Mammalian Viruses Using a Unique Membrane System, Part I: Membrane Qualification," Biologicals 21, 275-286 (1993).
38. A.J. DiLeo, D.A. Vacante, and E. Deane, "Size Exclusion Removal of Model Mammalian Viruses Using a Unique Membrane System, Part II: Module Qualification and Process Simulation," Biologicals 21, 287-296 (1993).
39. K.H. Oshima et al., "The Use of a Microporous Polyvinylidene Fluoride (PVDF) Membrane Filter to Separate Contaminating Viral Particles from Biologically Important Proteins," Biologicals 24, 137-145 (1996).
40. K.H. Oshima, T.T. Evans-Strickfaden, and A.K. Highsmith, "Comparison of Filtration Properties of Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Simian Virus 40 (SV40) Using a Polyvinylidene Fluoride (PVDF) Membrane Filter," Vox. Sang. 75, 185-188 (1998).
41. P. Roberts, "Efficient Removal of Viruses by a Novel Polyvinylidene Fluoride Membrane Filter," J. Virol. Methods 65, 27-31 (1997).
42. T. Burnouf, "Chromatographic Removal of Viruses from Plasma Derivatives," Dev. Biol. Stand. 81, 199-209 (1993).
43. E.D. Gomperts, "Procedures for the Inactivation of Viruses in Clotting Factor Concentrates," Am. J. Hematol. 23, 295-305 (1986).
44. J.J. Morgenthaler and A. Omar, "Partitioning and Inactivation of Viruses During Isolation of Albumin and Immunoglobulins by Cold Ethanol Fractionation, Dev. Biol. Stand. 81, 185-190 (1993).
45. T.W. Barrowcliffe, "Viral Inactivation vs. Biological Activity," Dev. Biol. Stand. 81, 125-135 (1993).
46. M. Gleeson, L. Herd, and C. Burns, "Effect of Heat Inactivation of HIV on Specific Serum Proteins and Tumour Markers," Ann. Clin. Biochem. 27, 592-594 (1990).
47. A.M. Prince et al., "The Development of Virus-Free Labile Blood Derivatives: A Review," Eur. J. Epidemiol. 3, 103-118 (1987).
48. M.C. Swanson et al., "IgE and IgG Antibodies to β-Propiolactone and Human Serum Albumin Associated with Urticarial Reactions to Rabies Vaccine," J. Infect. Disease 155, 909-913 (1987).
49. K. Peerlinck et al., "A Higher Than Expected Incidence of Factor VIII Inhibitors in Multitransfused Haemophilia A Patients Treated with an Intermediate Purity Pasteurized Factor VIII Concentrate," Thromb. Haemost. 69, 115-118 (1993).
50. C.V. Prowse and A.E. Williams, "A Comparison of the In Vitro and In Vivo Thrombogenic Activity of Factor IX Concentrates in Stasis (Wessler) and Non-Stasis Rabbit Models," Thromb. Haemost. 44, 81-86 (1980).
51. N. Heimburger et al., "Factor VIII Concentrate, Highly Purified and Heated in Solution," Haemostasis 10 (Sup. 1), 204 (1981).
52. B. Horowitz, "Investigations into the Application of Tri(N-Butyl) Phosphate/Detergent Mixtures to Blood Derivatives," in Virus Inactivation in Plasma Products, J.J. Morgenthaler, Ed. Curr. Stud. Hematol. Blood Transfus. 56, 83-96 (1989).
53. P.M. Manucci, "Outbreak of Hepatitis A Among Italian Patients with Haemophilia," Lancet 339(8796), 819 (1992).
54. B.H. Robertson et al., "Hepatitis A Virus Sequences Detected in Clotting Factor Concentrates Associated with Disease Transmission," Biologicals 26, 95-99 (1998).
55. T.T. Yee et al., "Transmission of Symptomatic Parvovirus B19 Infection by Clotting Factor Concentrate," Br. J. Haematol. 93, 457-459 (1996).
56. M.J. Savage et al., "Determination of Adequate Moisture Content for Efficient Dry-Heat Viral Inactivation in Lyophilized Factor VIII by Loss on Drying and by Near Infrared Spectroscopy," Biologicals 26, 119-124 (1998).
57. J.L. Melnick, "Virus Inactivation: Lessons from the Past," Dev. Biol. Stand. 75, 29-36 (1991).
58. P. Murphy et al., "Inactivation of Hepatitis A Virus by Heat Treatment in Aqueous Solution," J. Med. Virol. 41, 61-64 (1993).
59. K.J. Pasi and F.G.H. Hill, "Safety Trial of Heated Factor VIII Concentrate (8Y)," Arch. Dis. Child. 64, 1463-1467 (1989).
60. K.N. Prudouz and J.C. Fratantoni, "Viral Inactivation of Blood Products," in Scientific Basis of Transfusion Medicine, K.C. Anderson and P.M. Ness, Eds. (Saunders, Philadelphia, 1994), pp. 852-871.
61. A.M. Prince, W. Stephen, and B. Brotman, "β-Propiolactone/Ultraviolet Irradiation: A Review of Its Effectiveness for Inactivation of Viruses in Blood Derivatives," Rev. Infect. Dis. 5, 92-107 (1983).
62. H. Dichtelmuller et al., "Validation of Virus Inactivation and Removal for the Manufacturing Procedure of Two Immunoglobulins and a 5% Serum Protein Solution Treated with β-Propiolactone," Biologicals 21, 259-268 (1993).
63. J.L. Lundblad and R.L. Seng,"Inactivation of Lipid Enveloped Viruses in Proteins by Caprylate," Vox. Sang. 60, 75-81 (1991).
64. W.R. Alonso et al., "Viral Inactivation of Intramuscular Serum Globulins," Biologicals 28, 5-15 (2000).
65. M. Burnouf-Radosevich et al., "Nanofiltration, a New Specific Virus Elimination Method Applied to High-Purity Factor IX and Factor XI Concentrates," Vox. Sang. 67, 132-138 (1994).
66. S.A. Lawrence, "β-Propiolactone: Viral Inactivation in Vaccines and Plasma Products," PDA J. Pharm. Sci. Technol. 54, 209-217 (2000).
67. F. Knutson et al., "Photochemical Inactivation of Bacteria and HIV in Buffy-Coat-Derived Platelet Concentrates Under Conditions That Preserve In Vitro Platelet Function," Vox. Sang. 78, 209-216 (2000).
68. D. Vollenbroich et al., "Mechanism of Inactivation of Enveloped Viruses by the Biosurfactant Surfactin from Bacillus subtilis," Biologicals 25, 289-297 (1997).
69. J. Chapman, "Progress in Improving the Pathogen Safety of Red Cell Concentrates," Vox. Sang. 78 (Sup. 2), 203-204 (2000).
70. D.W. Bradley et al., "Pressure Cycling Technology: A Novel Approach to Virus Inactivation in Plasma," Transfusion 40, 193-200 (2000).
71. J.P. Fox et al., "Observation on the Occurrence of Icterus in Brazil Following Vaccination Against Yellow Fever," Am. J. Hyg. 36, 68-116 (1942).
72. E.M. Lackritz et al., "Estimated Risk of Transmission of the Human Immunodeficiency Virus by Screened Blood in the United States," New. Engl. J. Med. 26, 1721-1725 (1995).
73. H. Anazawa, I.E. Lee, and K. Sakai, "HIV Removal Efficiency of Pall Ultipor(R)VF DV50 Virus Removal Filter," Pharm. Tech. Japan 13, 951-955 (1997).
74. H. Scheiblauer et al., "Prevalence of Hepatitis C Virus in Plasma Pools and the Effectiveness of Cold Ethanol Fractionation," Clin. Ther. 18 (Sup. B), 59-70 (1996).
75. P.M. Mannucci and M. Colombo,"Virucidal Treatment of Factor Concentrates," Lancet 2 (8614), 782-785 (1988).
76. J.K. Walter, F. Nothelfer, and W. Werz, "Virus Removal and Inactivation, a Decade of Validation Studies: Critical Evaluation of the Data Set," in Validation of Biopharmaceutical Manufacturing Processes, B.D. Kelley and R.A. Ramelmeier, Eds., ACS Symposium Series 698 (American Chemical Society, Washington, DC, 1998).