Assessment of the potential of plasma fractionation processes to remove causative agents of transmissible spongiform encephalopathy

Transfusion Medicine

Volumn 9, Issue 1, 1999, Pages 3-14

  Foster, P R ^a  

^a SCOTTISH NATIONAL BLOOD TRANSFUSION SERVICE   (United Kingdom)

Author keywords

Creutzfeldt Jakob disease; New variant CJD; Partitioning of CJD scrapie; Plasma fractionation; Plasma products

Indexed keywords

ANTIMICROBIAL ACTIVITY; BRAIN SPONGIOSIS; CREUTZFELDT JAKOB DISEASE; FRACTIONATION; PLASMA; PRION; UNITED KINGDOM;

EID: 0033104250     PISSN: 09587578     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1365-3148.1999.009001003.x     Document Type: Article

References (59)

1. Almond, J. & Pattison, J. (1997) Human BSE. Nature, 389, 437-438.
2. Bader, F., Davis, G., Dinowitz, M., Garfinkle, B., Harvey, J., Kozak, R., Lubiniecki, A., Rubino, M., Schubert, D., Wiebe, M. & Woollett, G. (1998) Assessment of risk of Bovine Spongiform Encephalopathy in pharmaceutical products, part 1. Biopharm, 11 (20-31), 56.
3. Baker, H.F. & Ridley, R.M., eds. (1996) Prion Diseases. Humana Press, New Jersey.
4. Bendheim, P.E., Bockman, J.M., McKinley, M.P., Kingsbury, D.T. & Prusiner, S.B. (1985) Scrapie and Creutzfeldt-Jakob disease prion proteins share physical properties and antigenic determinants. Proceedings of the National Academy of Sciences of the United States of America, 82, 997-1001.
5. Bhattacharya, P., Bunch, C., Ngo, C., Gayleard, L., Hwang, D., Uemura, Y. & Heldebrant, C. (1996) Inactivation and removal of viruses during the manufacturing process of human albumin. Haemophilia, 2 (Suppl. 1), 23.
6. Blum, M., Budnick, M.O., Chait, E.M., Vaz, W.E., MacAuley, C. & Rohwer, R.G. (1998) A bovine spongiform encephalopathy validation study for aprotinin and bovine serum albumin. Biopharm, 11, 28-34.
7. Bolton, D.C., Bendheim, P.E., Marmorstein, A.D. & Potomska, A. (1987) Isolation and structural studies of the intact scrapie agent protein. Archives of Biochemistry and Biophysics, 258, 579-590.
8. Brown, P. (1995) Can Creutzfeldt-Jakob disease be transmitted by transfusion. Current Opinion in Haematology, 2, 472-477.
9. Brown, P. (1998) On the origins of BSE. Lancet, 352, 252-253.
10. Brown, P., Preece, M.A. & Will, R.G. (1992) 'Friendly fire' in medicine: hormones, homografts and Creutzfeldt-Jakob disease. Lancet, 340, 24-27.
11. Brown, P., Rohwer, R.G., Dunstan, B.C., MacAuley, C., Gajdusek, D.C. & Drohan, W.N. (1998) The distribution of infectivity in blood components and plasma derivatives in experimental models of transmissible spongiform encephalopathy. Transfusion, 38, 810-816.
12. Budnick, M.O., Cosenza, T. A. & Black, J. (1994) Clearance of adventitious virus during bovine-albumin manufacture. Biopharm, 7, 32-37.
13. Burnouf, T. (1993) Chromatographic removal of viruses from plasma derivatives. Developments in Biological Standardization, 81, 199-209.
14. Burnouf, T. (1995) Chromatography in plasma fractionation: benefits and future trends. Journal of Chromatography Biomedical Applications, 664, 3-15.
15. Cohn, E.J., Strong, L.E., Hughes, W.L., Mulford, D.J., Ashworth, J.N., Melin, M. & Taylor, H.L. (1946) Preparation and properties of serum and plasma proteins IV: a system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. Journal of the American Chemical Society, 68, 459-475.
16. Cousens, S.N., Vynnycky, E., Zeidler, M., Will, R.G. & Smith, P.G. (1997) Predicting the CJD epidemic in humans. Nature, 385, 197-198.
17. CPMP. (1992) Guidelines for minimising the risk of transmitting agents causing Spongiform Encephalopathy via medicinal products. Biologicals, 20, 155-158.
18. CPMP. (1998) Position statement on new variant CJD and plasma-derived medicinal products. CPMP/201/98. European Agency for the Evaluation of Medicinal Products, London, 25 February.
19. Cuthbertson, B., Reid, K.G. & Foster, P.R. (1991) Viral contamination of human plasma and procedures for preventing virus transmission by plasma products. In: Blood Separation and Plasma Fractionation (ed. Harris, J.R.), 385-435. Wiley-Liss Inc., New York.
20. Darling, A.J. & Spaltro, J.J. (1996) Process validation for virus removal: considerations for design of process studies and viral assays. Biopharm, 9, 42-50.
21. Donne, D.G., Viles, J.H., Groth, D.F., Mehlhorn, I., James, T.L., Cohen, F.E., Prusiner, S.B., Wright, P.E. & Dyson, H.J. (1997) Structure of the recombinant full-length hamster prion protein PrP (29-231): the N terminus is highly flexible. Proceedings of the National Academy of Sciences of the United States of America, 94, 13452-13457.
22. Edenhofer, F., Weiss, S., Winnacker, E.L. & Famulok, M. (1997) Chemistry and molecular biology of transmissible spongiform encephalopathies. Angewandte Chemie, International Edition in English, 36, 1674-1694.
23. Esmonde, T.F.G., Will, R.G., Slattery, J.M., Knight, R., Harries-Jones, R., DeSilva, R. & Matthew, W.B. (1993) Creutzfeldt-Jakob disease and blood transfusion. Lancet, 341, 205-207.
24. Evatt, B.L. (1998) Prions and haemophilia: assessment of risk. Haemophilia, 4, 628-633.
25. Evatt, B.L., Austin, H., Barnhart, E., Schonberger, L., Sharer, L., Jones, R. & DeArmond, S. (1998) Surveillance for Creutzfeldt-Jakob disease among persons with hemophilia. Transfusion, 38, 817-820.
26. Farquhar, C.E., Sommerville, R.A. & Bruce, M.E. (1998) Straining the prion hypothesis. Nature, 391, 345-346.
27. FDA. (1995) Precautionary measures to further reduce the possible risk of transmission of Creutzfeldt-Jakob disease by blood and blood products. Memorandum from Center for Biologies Evaluation and Research, Bethesda, 8 August.
28. FDA. (1998a) Difficulty in Obtaining Immune Globulin Intravenous (Human). Dear Doctor Letter. Memorandum from Center for Biologies Evaluation and Research, Bethesda, 28 January.
29. FDA. (1998b) Change to the guidance entitled 'Revised precautionary measures to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) by blood and blood products. Notice from Center for Biologies Evaluation and Research, Bethesda, 8 September.
30. Foster, P.R. (1994) Blood plasma fractionation. In: The Kirk-Othmer Encyclopaedia of Chemical Technology, 4th edn, Vol. 11, 990-1021. Wiley, New York.
31. Foster, P.R., Cuthbertson, B., McIntosh, R.V. & MacLeod, A.J. (1997) Safer clotting factor concentrates. In: Hemophilia (eds Forbes, C.D., Aledort, L., Madhok, R.), 307-332. Chapman-Hall Medical, London.
32. Gasset, M., Baldwin, M.A., Fletterick, R.J. & Prusiner, R.B. (1993) Perturbation of the secondary structure of the scrapie prion protein under conditions that alter infectivity. Proceedings of the National Academy of Sciences of the United States of America, 90, 1-5.
33. Golker, C.F., Whiteman, M.D., Gugel, K.H., Gilles, R., Stadler, P., Kovatch, R.M., Lister, D., Wisher, M.H., Calcagni, C. & Hubner, G.E. (1996) Reduction of the infectivity of scrapie agent as a model for BSE in the manufacturing process of Trasylol®. Biologicals, 24, 103-111.
34. Grandgeorge, M., Labatut, R., Rouzioux, J.M., Tayot, J.L. & Veron, J.L. (1997) Method for removing unconventional transmissible agents from a protein solution. International Patent Application, WO 97/34642. 25 September.
35. Groschup, M.H., Harmeyer, S. & Pfaff, E. (1997) Antigenic features of prion proteins of sheep and of other mammalian species. Journal of Immunological Methods, 207, 89-101.
36. Hageman, T.C. (1991) An analysis of clearance factor measurements performed by spiking experiments. Biopharm, 4, 39-41.
37. Hill, A.F., Zeidler, M., Ironside, J. & Collinge, J. (1997) Diagnosis of new variant Creutzfeldt-Jakob disease by tonsil biopsy. Lancet, 349, 99-100.
38. Hoofnagle, J.H. & Barker, L.F. (1976) Hepatitis B virus and albumin products. Proceedings of the Workshop on Albumin; Dept Health Education and Welfare; publication no. (NIH) 76-925, Bethesda, February 1975, 305-314. DHEW, Bethesda.
39. Hunter, G.D. & Millson, G.G. (1964) Studies on the heat stability and Chromatographic behaviour of the scrapie agent. Journal of General Microbiology, 37, 251-258.
40. Kimberlin, R.H. (1996) Bovine spongiform encephalopathy and public health: some problems and solutions in assessing the risks. In: Transmissible Subacute Spongiform Encephalopathies: Prion Diseases (eds Court, L., Dodet, B.), 487-502. Elsevier, Paris.
41. Kozak, R.W., Golker, C.F. & Stadler, P. (1996) Transmissible spongiform encephalopathies (TSE): minimising the risk of transmission by biological/ biopharmaceutical products: an industry perspective. Developments in Biological Standardization, 88, 257-264.
42. Kuroda, Y., Gibbs, C.J., Amyx, H.L. & Gajdusek, D.C. (1983) Creutzfeldt-Jakob disease in mice: persistent viremia and preferential replication of virus in low-density lymphocytes. Infection and Immunity, 41, 154-161.
43. Ludlam, C.A. (1997) New-variant Creutzfeldt-Jakob disease and treatment of haemophilia. Lancet, 350, 1740.
44. McKinley, M.P., Meyer, R.K., Kenaga, L., Rahbar, F., Cotter, R., Serban, A. & Prusiner, S.B. (1991) Scrapie prion rod formation in vitro requires both detergent extraction and limited proteolysis. Journal of Virology, 65, 1340-1351.
45. Meltzer, T.H. (1987) Filtration in the Pharmaceutical Industry. Marcel Dekker Inc., New York.
46. Meyer, R.K., McKinley, M.P., Bowman, K.A., Braunfeld, M.B., Barry, R.A. & Prusiner, S.B. (1986) Separation and properties of cellular and scrapie prion proteins. Proceedings of the National Academy of Sciences of the United States of America, 83, 2310-2314.
47. Pennell, R.B. (1957) The distribution of certain viruses in the fractionation of plasma. In: Hepatitis Frontiers (eds Hartman, F.W., LoGrippo, G.A., Mateer, J.G., Barron, G.), 297-310. Churchill, London.
48. RES partitioning during selected plasma fractionation process steps. Haemophilia, 4, 166.
49. Prusiner, S.B., Groth, D.F., Cochran, S.P., Masiarz, F.R., McKinley, M.P. & Martinez, H.M. (1980) Molecular properties partial purification, and assay by incubation period measurements of the hamster scrapie agent. Biochemistry, 19, 4883-4891.
50. Ricketts, M.R., Cashman, N.R., Stratton, E.E. & Elsaadony, S. (1997) Is Creutzfeldt-Jakob disease transmitted in blood. Emerging Infectious Diseases, 3, 155-163.
51. Rider, J.R., Winter, M.A., Payrat, J.M., Mathias, J.M. & Pamphilon, D.H. (1998) Leucocytes can be eliminated from plasma by filtration prior to viral inactivation with methylene blue. Vox Sanguinis, 74, 209-210.
52. Rohwer, R.G. (1996) The management of risk from exposure of biomedical products to the spongiform encephalopathy agent (s). In: Transmissible Subacute Spongiform Encephalopathies: Prion Diseases (eds Court, L., Dodet, B.), 471-478. Elsevier, Paris.
53. Scottish Centre for Infection and Environmental Health. (1998) Monthly surveillance figures for Creutzfeldt-Jakob disease. SCIEH Weekly Report, (6 October), 32, (98/40):1.
54. Stahl, N., Borchelt, D.R. & Prusiner, S.B. (1990) Differential release of cellular and scrapie prion proteins from cellular membranes by phosphatidylinositol-specific phospholipase C. Biochemistry, 29, 5405-5412.
55. Taylor, D.M. (1996) Transmissible subacute spongiform encephalopathies: practical aspects of agent inactivation. In: Transmissible Subacute Spongiform Encephalopathies: Prion Diseases (eds Court, L., Dodet, B.), 479-482. Elsevier, Paris.
56. Taylor, D.M., Dickinson, A.G., Fraser, H., Robertson, P.A., Salacinski, P.R. & Lowry, P.J. (1985) The preparation of growth hormone free from contamination with unconventional slow viruses. Lancet, ii, 260-262.
57. Turk, E., Teplow, D.B., Hood, L.E. & Prusiner, S.B. (1988) Purification and properties of the cellular and scrapie hamster prion proteins. European Journal of Biochemistry, 176, 21-30.
58. Warden, J. (1998) UK blood products are banned. British Medical Journal, 316, 726.
59. Will, R.G., Ironside, J.W., Zeidler, M., Cousens, S.N., Estibeiro, K., Alperovitch, A., Poser, S., Pocchiari, M. & Hofman, A. (1996) A new variant of Creutzfeldt-Jakob disease in the UK. Lancet, 347, 921-925.