Issues in the development of medical products based on human plasma

Journal of Chromatography B: Biomedical Applications

Volumn 694, Issue 2, 1997, Pages 253-269

  Josić, Djuro ^a   Schulz, Petra ^a   Biesert, Lothar ^a   Hoffer, Lutz ^a   Schwinn, Horst ^a   Kordis Krapez, Mira ^a   Strancar, Ales ^a  

^a Octapharma Pharmazeutika Produktions GmbH   (Austria)

Author keywords

Factor IX; Factor VIII; Immunoglobulins; Plasma based medical products; Virus inactivated plasma

Indexed keywords

BLOOD CLOTTING FACTOR 8; BLOOD CLOTTING FACTOR 9; IMMUNOGLOBULIN;

ANALYTIC METHOD; BLOOD; CONTROLLED STUDY; DRUG CONTROL; DRUG DEVELOPMENT; DRUG ISOLATION; DRUG PURITY; HUMAN; HUMAN TISSUE; NORMAL HUMAN; PRIORITY JOURNAL; PROTEIN PURIFICATION; QUALITY CONTROL; REVIEW; VIRUS INACTIVATION;

BIOLOGICAL PRODUCTS; BLOOD PROTEINS; CHROMATOGRAPHY, AFFINITY; CHROMATOGRAPHY, ION EXCHANGE; DETERGENTS; DRUG CONTAMINATION; HUMANS; OCTOXYNOL; PLASMA; REPRODUCIBILITY OF RESULTS; SAFETY; VIRUS DISEASES; VIRUSES;

EID: 0030855831     PISSN: 15726495     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0378-4347(97)00130-8     Document Type: Review

References (51)

1. R. Ryan, Official J. Eur. Communities, No. L 147/13 Second Council Directive of 20 May 1975 (75/319 EEC) 25.
2. Cohn E.J., Strong L.E., Hughes W.L. Jr., Mulford D.J., Asworth J.N., Melin M., Taylor H.L. J. Am. Chem. Soc. 68:1946;459.
3. J.-C. Janson and T. Pettersson, in G. Ganetsos and P.E. Barker (Editors), Preparative and Production Scale Chromatography, Marcel Dekker, New York, NY, 1993, p. 559.
4. Zettmeissl G., Ragg H., Karges H.E. Biotechnology. 5:1987;720.
5. Collen D., Stassen J.M., Marafino B.J. Jr., Builder S., DeCock F., Ogez J. J. Pharmacol. Exp. Ther. 231:1984;146.
6. Wion K.L., Kelly D., Summerfield J.A., Tuddenham E.G.D., Lawn R.M. Nature. 317:1985;726.
7. Kaufmann R.J., Wasley L.C., Dorner A.J. J. Biol. Chem. 263:1988;6352.
8. Kaufmann R.J., Wasley L.C., Furrie B.C., Furrie B., Shoemaker C.B. J. Biol. Chem. 261:1986;9622.
9. Fischer B., Mitterer A., Schlokat U., DenBouwmeester R., Dorner F. FEBS Lett. 351:1994;345.
10. Janis L.J., Kovach P.M., Riggin R.M., Towus J.K. Methods Enzymol. 271:1996;86.
11. Josić Dj., Zeilinger K. Methods Enzymol. 271:1996;113.
12. Jungbauer A. Curr. Opin. Biotechnol. 7:1996;210.
13. Lower C.R. Curr. Opin. Biotechnol. 7:1996;1.
14. A.W. Guzzeta and W.S. Hancock, in W.S. Hancock (Editor), Peptide Mapping for the Characterization of Proteins, CRC Press, Boca Raton, FL, 1996.
15. Csen H., Horváth Cs. J. Chromatogr. A. 705:1995;3.
16. Jungbauer A., Boschetti E. J. Chromatogr. B. 662:1994;143.
17. Sofer G. Curr. Opin. Biotechnol. 6:1995;230.
18. Hoffer L., Schwinn H., Biesert L., Josić Dj. J. Chromatrogr. B. 669:1995;187.
19. Burnouf T. J. Chromatogr. B. 664:1995;3.
20. Morfeld F., Schütz R., Josić Dj., Schwinn H. Pharm. Ind. 58:1996;433.
21. Horowitz B., Bonomo R., Prince A.M., Chin S.N., Brotman B., Schulman R.W. Blood. 79:1992;826.
22. Lambrecht B., Mohr H., Knüver-Hopf J., Schmitt H. Vox Sang. 60:1991;207.
23. Strancar A., Raspor P., Schwinn H., Schütz R., Josić Dj. J. Chromatogr. A. 658:1994;475.
24. Piquet Y., Janvier G., Selosse P., Doutremepuich C., Jouneau J., Nicolle G., Platel D., Vezon G. Vox Sang. 63:1992;251.
25. Chew N. Biopharm. 6:1993;24.
26. Biesert L. Clin. Exp. Reumatol. 14:1996;47.
27. EEC Regulatory Documents III/8115/89-EN, published in Biologicals, 19 (1991) 247 and 20 (1992) 159.
28. EEC Regulatory Documents III/8115/89-EN, published in Biologicals, 19 (1991) 247 and 20 (1992) 159.
29. Trijzelaar B. Biotherapy. 6:1993;93.
30. Grun J.B., White E.M., Sito A.F. Biopharm. 5:1992;22.
31. J. Hilfenhaus, M. Niedrig and T. Nowak, in F. Brown (Editor), Virological Safety Aspects of Plasma Derivatives. Developments in Biological Standardization, Karger, Basel, Vol. 81, 1993, p. 117.
32. P.D. Minor, in F. Brown (Editor), Virological Safety Aspects of Plasma Derivatives. Developments in Biological Standardization, Karger, Basel, Vol. 81, 1993, p. 215.
33. Eriksson B., Westman L., Jernberg M. Blood Coagul. Fibrinol. 5(3):1994;37.
34. H. Willkommen and J. Löwer, in F. Brown (Editor), Virological Safety Aspects of Plasma Derivatives. Developments in Biological Standardization, Karger, Basel, Vol. 81, 1993, p. 109.
35. Schwinn H., Stadler M., Josić Dj., Bal F., Gehringer W., Nur I., Schütz R. Arzneim.-Forsch. Drug Res. 44(I):1994;188.
36. Josić Dj., Schwinn H., Stadler M., Strancar A. J. Chromatogr. B. 662:1994;181.
37. Yu M.W., Mason B.L., Guo Z.P., Tankersleg D.L., Nedjar S., Mitchell F.D., Biswas R.M. Lancet. 345:1995;1173.
38. Yei S., Yu M.W., Tankersleg D.L. Transfusion. 32:1992;824.
39. Yap P.L. Clin. Exp. Immunol. 104:1996;35.
40. Burnouf-Radosevich M., Appourchaux P., Huart J.J., Burnouf T. Vox Sang. 67:1994;132.
41. Hamamoto Y., Harada S., Kobayoshi S., Yamaguchi K., Iijima H., Manabe S.I., Tsurumi T., Aizawa H., Yamamoto N. Vox Sang. 56:1989;230.
42. Hoffer L., Biesert L., Josić Dj., Schwinn H. Haemophilia. 2:1996;81.
43. Burnouf T., Burnouf-Radosevich M., Huart J.J., Goudemand M. Vox Sang. 62:1991;8.
44. Strancar A., Koselj P., Schwinn H., Josić Dj. Anal. Chem. 68:1996;3483.
45. Barry A., Chojnacki R. Biopharm. 7:1994;43.
46. Seely R.J., Wight H.D., Fry H.H., Rudge S.R., Slaft G.F. Pharm. Technol. Eur. December:1994;32.
47. Burgoyne R.F., Priest M.C., Roche K.L., Vella G. J. Pharm. Biomed. Anal. 11:1993;1317.
48. Johansson B.-L. Biopharm. 5:1992;34.
49. Stone T.E., Goel V., Leszczak J. Pharm. Technol. October:1994;116.
50. Knight P. Biotechnology. 7:1989;777.
51. CPMP/117/95: Intramuscular Immunoglobulins: Nucleic Acid Amplification Tests for HCV RNA Detection, CPMP Plenary Meeting, London, EMEA, 26-27 April 1995.