Virus Safety of Cell-derived Biological Products

Medicines from Animal Cell Culture

Volumn , Issue , 2007, Pages 371-392

  Roberts, Peter L ^a  

^a BIO PRODUCTS LABORATORY   (United Kingdom)

Author keywords

Cell derived biological products and good microbiological safety record; Prion reduction steps; Virus removal inactivation methods; Virus safety of cell derived biological products; Virus testing and reduction approach

Indexed keywords

EID: 84889474697     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9780470723791.ch19     Document Type: Chapter

References (126)

1. Amareld RW Jr, Wersocki M, Drohan M et al. (2003) Biologicals; 31: 261-264.
2. Aranha H (2001) BioPharm.; Feb: 32-42.
3. Barrett PN, Meyer H, Wachtel I, Eibl J, Dorner F (1997) Transfusion; 37: 215-216.
4. Baker RM, Brady A-M, Combridge BS et al. (1994) In Separations for Biotechnology 3. Ed Pyle DL Royal Society of Chemistry, Cambridge; 53-59.
5. Bauer BA, Besch-Williford B, Riley LK (2004) Biologicals; 32: 177-182.
6. Bergvall P, Ahmad T, Baumann H, Wadensten H, Towner M (2001) Plasma Products Biotechnology Meeting 2001, Downstream PPB 2001. Amersham Biosciences; 55-57.
7. Blank WA, Henderson KS, White LA (2004) Lab. Anim.; 33: 26-31.
8. Bos OJ, Sunye DG, Nieuweboer CE, van Engelenburg FA, Schuitemaker H, Over J (1998) Biologicals; 4: 267-276.
9. Bradley DW, Hess RA, Tao F et al. (2000) Transfusion; 40: 193-200.
10. Brorson K, Krejci S, Lee K, Hamilton E, Stein K, Xu Y (2003) Biotechnol. Bioeng.; 82: 321-329.
11. Brown F (1992) Dev. Biol. Stand; 81: 103-107.
12. Brown F (Ed) (1993) Virological Safety Aspects of Plasma Derivatives. Dev. Biol. Stand. 81.
13. Brown F, Lubiniecki A (Eds) (1996) Viral Safety and Evaluation of Viral Clearance from Biopharmaceutical Products. Dev. Biol. Stand. 88.
14. Brown F, Gartwright T, Horaud F, Spieser J-M (Eds) (1999) Animal Sera, Animal Sera Derivatives and Substitutes used in the Manufacture of Pharmaceuticals: Viral Safety and Regulatory Aspects. Dev. Biol. (Basel) 99.
15. Brown F, Griffiths E, Horand F, Petriccian JC (Eds) (1998) Safety of Biological Products Prepared from Mammalian cell Cultures. Dev. Biol. (Basel) 93.
16. Bruce ME, Will RG, Ironside JW et al. (1997) Nature; 389: 498-501.
17. Burnouf T (1993) Dev. Biol. Stand.; 81: 197-199.
18. Burnouf T, Radosevich M (2003) Haemophilia; 9: 24-37.
19. Burnouf-Radosevich M, Appourchaux P, Huart JJ, Burnouf T (1994) Vox Sang. 67: 132-138.
20. Caillet-Fauquet P, Di Giambattistra M, Draps ML, Sandras F et al. (2004) J. Virol Methods; 15: 131-139.
21. Carter J, Lutz H (2002) Euro. J. Parenter. Sci.; 7: 72-78.
22. Center for Biologics Evaluation and Research (1993) Points to Consider in the Characterisation of Cell Lines used to Produce Biologicals.
23. Center for Biologics Evaluation and Research (1997) Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use.
24. Charm SE, Landua S, Williams B, Horowitz B, Prince AM, Pascual D (1992) Vox Sang.; 62: 12-20.
25. Chin S, Williams B, Gottlieb P et al. (1995) Blood; 86: 4431-4436.
26. Chin S, Jin R, Wang XL et al. (1997) Photochem. Photobiol.; 65: 432-435.
27. Committee for Proprietary Medicinal Products, European Agency for the Evaluation of Medicinal Products (1996) Notes for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses. CPMP/BWP/268/95.
28. Committee for Proprietary Medicinal Products and Committee for Veterinary Medicinal Products, European Agency for the Evaluation of Medicinal Products (2001) Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products. EMEA/410/01.
29. Committee for Proprietary Medicinal Products for Human Use, European Agency for the Evaluation of Medicinal Products (2004) Guideline on the Investigation of Manufacturing Processes for Plasma-derived Medicinal Products with Regard to vCJD Risk. CPMP/BWP/CPMP/5136/03.
30. Corash L (2000) Vox Sang.; 78(suppl 2): 205-210.
31. Council of Europe Expert Committee in Blood Transfusion Study Group on Pathogen Inactivation of Labile Blood Components, Pathogen Inactivation of Labile Blood Products, (2001) Transfus. Med.; 11: 149-175.
32. Cover WH, Holloway JM, Xue H, Busby TF (2001) Plasma Products Biotechnology Meeting. Downstream PPB 2001. Amersham Biosciences; 42-44.
33. Dichtelmuller H, Rudnick D, Breuer B, Granshirt K (1993) Biologicals; 21: 259-268.
34. Dichtelmuller H, Rudnick D, Breuer B et al, (1996) Biologicals; 24: 125-130.
35. Dichtelmuller H, Rudnick D, Kloft M (2002) Biologicals; 30: 135-142.
36. DiLeo AJ, Vacante DA, Deane EF (1993) Biologicals; 21: 287-293.
37. Dorner F, Barrett N (1996) Hamostaseologie; 16: 282-285.
38. Dupuis K, Sampson-Johanne A, Bernard K (2004) Vox Sang; 67(suppl.3): 68
39. Edsall JT (1984) Vox Sang; 46: 338-340.
40. European Commission (1994) Note for Guidance on the Production and Quality Control of Monoclonal Antibodies, III/5271/94.
41. Feifel K, Zeiler M (2001) Pharma+Food Int.; 21-25.
42. Garcia AF, Heindl P, Voigt H et al. (2004) J. Gen. Virol.; 85: 261-264.
43. Garnick RL (1996) Dev. Biol. Stand.; 88: 49-56.
44. Goodrich RP (2000) Vox Sang; 78 (suppl 2): 211-215.
45. Grieb T, Forng R-Y, Brown R et al. (2002) Biologicals; 30: 207-216.
46. Hamalainen E, Suomela H, Ukkonen P (1992) Vox Sang; 63: 6-11.
47. Hamamoto Y, Harada S, Kobayashi S et al. (1989) Vox Sang; 56: 230-236.
48. Hart H, Reid K, Hart W (1993) Vox Sang; 64: 82-88.
49. Hart HF, Hart WG, Crossley J et al. (1994) Vox Sang; 67: 345-350.
50. Hiemstra H, Tersmette M, Vox AHV, Over J, van Berkel MP, DeBree H (1991) Transfusion; 31: 32-39.
51. Highsmith FA, Caple M, Walthall B, Shanbrom E, Drohan WN (1993) J. Infect. Dis.; 167, 1027-1033.
52. Highsmith FA, Xue H, Caple M, Walthall B, Drohan WN, Shanbrom E (1994) Transfusion; 34: 322-326.
53. Hill AF, Desbruslais M, Joiner S et al. (1997) Nature; 389: 448-450.
54. Horaud F, Brown F (Eds) (1991) Virological Aspects of the Safety of Biological Products. Dev Biol Stand 75.
55. Horowitz B, Weibe ME, Lippin A, Stryker MH (1985) Transfusion; 25: 516-522.
56. Horowitz B, Prince AM, Horowitz MS, Watklevicz C (1993) Dev. Biol. Stand.; 81: 147-161.
57. Hrinda ME, Huang C, Tarr GC, Weeks R (1991) Semin. Hematol.; 28: 6-14.
58. Hughes B, Bradburne A, Sheppard D, Young D (1996) Dev. Biol. Stand.; 88: 91-98.
59. HyClone Laboratories (1987) Art to Science in Tissue Culture; 5: 1-5.
60. International Conference on Harmonisation (1999). Q5A (R.1) Viral Safety Evaluation of Biotechnology Products Drived from Cell Lines of Human or Animal Origin.
61. Johnston A, Uren E, Johnstone D, Wu J (2003) Biologicals; 31: 213-221.
62. Kallenbach NR, Cornelium PA, Negus D, Montgomerie D, Englander S (1989) Curr. Stud. Haematol. Blood Transfus.; 56: 70-82.
63. Kasermann F, Kempf C (2003) J. Gen. Virol.; 84: 3173-3176.
64. Kempf C, Jentsch P, Poirier B (1991) Transfusion; 31: 423-427.
65. Kitchen AD, Mann GF, Harrison JF, Zuckerman AJ (1989) Vox Sang; 56: 223-229.
66. Korneyeva M, Hotta J, Lebing W, Rosenthal RS, Franks L, Petteway Jr SR (2002) Biologicals; 30: 153-156.
67. Lawrence JE (1993) Dev. Biol. Stand.; 81: 191-197.
68. Lazo A, Tassello J, Jayarama V et al. (2002) Vox Sang; 83: 313-323.
69. Levy RV, Phillips MW, Lutz H (1998) In Filtration in the Biopharmaceutical Industry. Eds Meltzer TH, Jornitz MW. Marcel Dekker, New York; 619-646
70. Liptrot C, Gull K (1996) In Cell and Tissue Culture: Laboratory Procedures. Eds Doyle A, Griffiths JB, Newell DG. John Wiley & Sons, Chichester; 7B:21-14.
71. Louie RE, Galloway CJ, Dumas ML, Wong MF, Mitra G (1994) Biologicals; 22: 13-19.
72. Lundblad JL, Seng RL (1991) Vox. Sang.; 60: 75-81.
73. MacLeod AJ (2004) Dev. Biol.; 118: 139-147.
74. Maerz H, Hahn SO, Maassen A et al. (1996) Nat. Biotechnol.; 14: 651-652.
75. Manabe S (1996) Dev. Biol. Stand.; 88: 81-90.
76. McLeod AH, Murdoch H, Dickinson J et al. (2004) Biochem. Biophys. Res. Commun.; 4: 1165-1170.
77. Miekka SI, Busby TF, Redi B, Pollock R, Ralston A, Drohan WD (1998) Haemophilia; 4: 402-408.
78. Miekka SI, Forng R-O, Rohwer RG et al. (2003) Vox. Sang.; 84: 36-44.
79. Minor PD (2004) Vox Sang.; 86: 164-170.
80. Morgenthaler JJ (1989) Curr. Stud. Hematol. Blood Transfus.; 56: 109-121.
81. Morgenthaler JJ, Omar A (1993) Dev. Biol. Stand.; 81: 185-190.
82. Nikagami T, Ohno H, Shigehisa T et al. (1996) Transfusion; 36: 575-576.
83. Norley SG, Lower J, Kurth R (1993) Biologicals; 21: 251-258.
84. Nowak T, Niedrig M, Bernhardt D, Hilfenhaus J (1993) Dev. Biol. Stand.; 81: 169-176.
85. Oshima KH, Evans-Strickfaden TT, Hightsmith AK, Ades EW (1996) Biologicals; 24: 137-145.
86. Over J (2000) Downstream; 31:26, Amersham Biosciences, Little Chalfont,UK.
87. Pall Process Filtration Ltd (1991) Pall Scientific and Technical Reports STR1358. Pall Process Filtration Ltd, Portsmouth, UK.
88. Potts BT (2003) PDA-EMEA European Virus Safety Forum. Langen, Germany, 29 Sept-1 Oct 2003. PDA, Bethesda, USA.
89. Prince AM, Horowitz B, Brotman B, Huima T, Richardson L van der Ende MC (1984) Vox Sang; 46: 36-43.
90. Prince AM, Horowitz B, Brotman B (1986) Lancet; 1: 706-710.
91. Prodouz KN, Fratanton JC (1994) In Scientific Basis of Transfusion Medicine. Eds Anderson KC, Ness PM. Saunders, Philadelphia; 852-871.
92. Prusiner SB (1991) Dev. Bio. Stand.; 75: 55-74.
93. Reid BD (1998) Biologicals; 26: 125-130.
94. Reid KG, Cuthbertson B, Jones ADL, McIntosh RV (1988) Vox Sang.; 55: 75-80.
95. Roberts PL (1994) In Separations for Biotechnology 3. Ed Pyle DL Royal Society of Chemistry, Cambridge; 420-426.
96. Roberts PL (1995) Vox Sang.; 68: 61-62.
97. Roberts PL, Walker CP, Feldman PA (1994) Vox Sang.; 67 (suppl): 132-138.
98. Roberts P (1996) Rev. Med. Virol.; 6: 25-38.
99. Roberts P (1997) J. Virol. Methods; 65: 27-31.
100. Roberts P (2000a) Eur. J. Parenter. Sci.; 5: 3-9.
101. Roberts P (2000b) Biologicals; 28: 29-32.
102. Roberts P, Sims S (1999) Biologicals; 27: 263-264.
103. Roberts PL (2002) In Basic Cell Culture: A Practical Approach. Ed Davis JM Oxford University Press, Oxford; second edition: 29-67.
104. Roberts PL, Dunkerley C (2003) Vox Sang.; 84: 170-175.
105. Roberts PL, Dunkerley C, McAuley A, Winkelman L (2007) Vox Sang.; 92:56-63.
106. Roberts PL, Hart H (2000) Biologicals; 28: 185-188.
107. Roberts P, Hope A (2003) J. Virol. Methods; 110: 61-65.
108. Robertson JS (ED) (2004) PDA/EMEA European Virus Safety Forum Dev. Biol (Basel) 118.
109. Robertson JS, Nicolson C, Riley AM et al. (1997) Biologicals; 25: 403-414.
110. Rosendaal FR, Nieuwenhuis HK, van den Berg et al. (1993) Blood; 81:2180-2186.
111. Ruane PH, Edrich R, Campp D, Keil SD, Leonard RL, Goodrich RP (2004) Transfusion; 44: 877-885.
112. Santagostino E, Mannucci PM, Gringeri AA et al. (1997) Transfusion; 37: 517-522.
113. Scheidler A, Rokos K, Reuter T, Ebermann R, Pauli G (1998) Biologicals; 26: 135-144.
114. Skladanek M (2001) PDA/FDA Viral Clearance Forum (Bethesda, MD, 1-3 October 2001) PDA, Bethesda, USA.
115. Tateishi J, Kitamoto T, Mohri S et al. (2001) Biologicals; 29: 17-25.
116. Taylor DM (1991) Dev. Biol. Stand.; 75: 97-102.
117. Tran H, Marlowe K, McKenney K et al. (2004) Biologicals; 32: 94-104.
118. Van Holten RW, Autenrieth S, Boose JA, Hsieh WT, Dolan S (2002) Transfusion; 8: 999-1004.
119. Wainwright M (2002) Curr. Med. Chem.; 9: 127-143.
120. Wang J, Mauser A, Chao SF, Remington K et al. (2004) Vox Sang.; 86: 230-238.
121. Weissmann C (2004) Nat. Rev. Microbiol.; 2: 861-871.
122. Winkelman L, Feldman PA, Evans DR (1989) Curr. Stud. Hematol. Blood Transfus.; 56: 55-69.
123. World Health Organization (1998), WHO Requirements for the Use of Animal Cells as In Vitro Substrates for the Production of Biologicals (Requirements for Biological Substances No. 50); Biologicals 26: 175-193.
124. World Health Organization (2003) WHO Guidelines on Transmissible Spongiform Encephalopathies in Relation to Biological and Pharmaceutical Products. WHO/BCT/QSD/03.01.
125. Yei S, Yu MW, Tankersley DL (1992) Transfusion; 32: 824-828.
126. Yokoyama T, Murai K, Murozuka A, Tanifuji M, Fuji N, Tomono T (2004) Vox Sang.; 86: 225-229.