Viral safety characteristics of Flebogamma® DIF, a new pasteurized, solvent-detergent treated and Planova 20 nm nanofiltered intravenous immunoglobulin

Biologicals

Volumn 38, Issue 4, 2010, Pages 486-493

  Caballero, Santiago ^a   Nieto, Sandra ^a   Gajardo, Rodrigo ^a   Jorquera, Juan I ^a  

^a Instituto Grifols   (Spain)

Author keywords

Intravenous immunoglobulin; Nanofiltration; Pasteurization; Solvent detergent; Viral safety

Indexed keywords

IMMUNOGLOBULIN;

ARTICLE; CONTROLLED STUDY; DRUG CONTAMINATION; DRUG MANUFACTURE; NANOFILTRATION; NONHUMAN; PASTEURIZATION; PRIORITY JOURNAL; VIRAL CONTAMINATION; VIRUS INACTIVATION; VIRUS INFECTIVITY; VIRUS PLAQUE;

CHEMICAL FRACTIONATION; CHROMATOGRAPHY, ION EXCHANGE; DETERGENTS; DRUG CONTAMINATION; HUMANS; IMMUNOGLOBULINS, INTRAVENOUS; PLAQUE ASSAY; PLASMA; POLYETHYLENE GLYCOLS; SOLVENTS; STERILIZATION; ULTRAFILTRATION; VIRUS INACTIVATION;

EID: 77955270563     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.02.008     Document Type: Article

References (43)

1. Stiehm E.R. Human intravenous immunoglobulin in primary and secondary antibody deficiencies. Pediatr Infect Dis 1997, 16:696-707.
2. Dwyer J.M. Immunoglobulins in autoimmunity: history and mechanism of action. Clin Exp Rheumatol 1996, 14(Suppl. 15):S3-S7.
3. Ramesh S., Schwartz S.A. Therapeutic uses of intravenous immunoglobulin (IVIg) in children. Pediatr Rev 1995, 16:403-410.
4. EMEA CPMP note for guidance on virus validation studies: the design, contribution and interpretation of studies validating the inactivation and removal of viruses 1996, Available at, CPMP/BWP/268/95/Rev. http://www.emea.europa.eu/pdfs/human/bwp/026895en.pdf.
5. EMEA CPMP note for guidance on plasma derived medicinal products 2001, 3. Available at, CPMP/BWP/269/95/Rev. http://www.emea.europa.eu/pdfs/human/bwp/026995en.pdf.
6. EMEA ICH Topic Q 5 A (R1) note for guidance on quality of biotechnological products: viral safety evaluation of biotechnology products derived from cell lines of human or animal origin 1997, Available at, CPMP/ICH/295/95. http://www.emea.europa.eu/pdfs/human/ich/029595en.pdf.
7. Heimburger N., Karges H.E. Strategies to produce virus-safe blood derivatives. Curr Stud Hematol Blood Transfus 1989, 56:23-33.
8. Menache D., Aronson D.L. Measures of inactivate viral contaminants of pooled plasma products. Prog Clin Biol Res 1985, 182:407-423.
9. Berger M., Flebogamma 5% DIF Investigators A multicenter, prospective, open label, historically controlled clinical trial to evaluate efficacy and safety in primary immunodeficiency diseases (PID) patients of Flebogamma 5% DIF, the next generation of Flebogamma. J Clin Immunol 2007, 27:628-633.
10. Dichtelmüller H.O., Biesert L., Fabbrizzi F., Gajardo R., Gröner A., von Hoegen I., et al. Robustness of solvent/detergent treatment of plasma derivatives: a data collection from Plasma Protein Therapeutics Association member companies. Transfusion 2009, 49:1931-1943.
11. Burnouf T. Value of virus filtration as a method for improving the safety of plasma products. Vox Sang 1996, 70:235-236.
12. Jorquera J.I. Flebogamma® 5% DIF development: rationale for a new option in IVIG therapy. Clin Exp Immunol 2009, 157(Suppl 1):17-21.
13. Ristol P, Rabaneda F, Lopez T. Procedimiento para la producción de gammaglobulina G humana inactivada de virus. Spanish patent ES 1 184 594 B1; 2004.
14. Cohn E.J., Strong L.E., Hughes W.L., Mulford D.F., Ashworth J.N., Melin M., et al. 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. J Amer Chem Society 1946, 68:459-475.
15. Cohn E.J., Gurd F.R.N., Surgenor D.M., Barnes B.A., Brown R.K., Derouaux G., et al. A system for the separation of the components of human blood: quantitative procedures for the separation of the protein components of human plasma. J Amer Chem Society 1950, 72:465-474.
16. Reed L., Muench H. A simple method of estimating fifty percent endpoints. Am J Hyg 1938, 27:493-497.
17. Kärber G. Beitrag zur Kollektiven behandlung pharmakologischer reihenversuche. Arch Exp Pathol Pharmakol 1931, 162:480-483.
18. Bos O., Sunyé D., Nieuweboer C., van Engelenburg F., Schuitemaker H., Over J. Virus validation of pH4-treated human immunoglobulin products produced by the Cohn fractionation process. Biologicals 1998, 26:267-276.
19. Uemura Y., Joy Yang Y.H., Heldebrant C.M., Takechi K., Yokoyama K. Inactivation and elimination of viruses during preparation of human intravenous immunoglobulin. Vox Sang 1994, 67:246-254.
20. Terpstra F.G., Kleijn M., Koenderman A.H., Over J., van Engelenburg F.A., Schuitemaker H., et al. Viral safety of C1-inhibitor NF. Biologicals 2007, 35:173-181.
21. Poelsler G., Berting A., Kindermann J., Spruth M., Hämmerle T., Teschner W., et al. A new liquid intravenous immunoglobulin with three dedicated virus reduction steps: virus and prion reduction capacity. Vox Sang 2008, 94:184-192.
22. ®, a new 15 nm-filtered liquid immunoglobulin product. Vox Sang 2006, 90:21-32.
23. Boschetti N., Niederhauser I., Kempf C., Stühler A., Löwer J., Blümel J. Different susceptibility of B19 virus and mice minute virus to low pH treatment. Transfusion 2004, 44:1079-1086.
24. 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 1999, 39:249-257.
25. Kreil T.R., Unger U., Orth S.M., Petutschnig G., Kistner O., Poelsler G., et al. H5N1 influenza virus and the safety of plasma products. Transfusion 2007, 47:452-459.
26. Mpandi M., Schmutz P., Legrand E., Duc R., Geinoz J., Henzelin-Nkubana C., et al. Partitioning and inactivation of viruses by the caprylic acid precipitation followed by a terminal pasteurization in the manufacturing process of horse immunoglobulins. Biologicals 2007, 35:335-341.
27. Biescas H, Gensana M, Fernández J, Ristol P, Massot M, Watson E, et al. Characterization and viral safety validation study of a pasteurized therapeutic concentrate of antithrombin III obtained through affinity chromatography. Haematologica;83(4):305-311.
28. Hattori S., Yunoki M., Tsujikawa M., Urayama T., Tachibana Y., Yamamoto I., et al. Variability of parvovirus B19 to inactivation by liquid heating in plasma products. Vox Sang 2007, 92:121-124.
29. Blümel J., Schmidt I., Willkommen H., Löwer J. Inactivation of parvovirus B19 during pasteurization of human serum albumin. Transfusion 2002, 42:1011-1018.
30. Horowitz B., Prince A.M., Horowitz M.S., Watklevicz C. Virus safety of solvent-detergent treated blood products. Virological safety aspects of plasma derivatives 1993, vol. 81:147-161. Dev Biol Stand, Karger, Basel. F. Brown (Ed.).
31. Biesert L. Virus validation studies of immunoglobulin preparations. Clin Exp Rheumatol 1996, 14(Suppl 15):S47-S52.
32. Biesert L., Suhartono H. Solvent/detergent treatment of human plasma - a very robust method for virus inactivation. Validated virus safety of OCTAPLAS. Vox Sang 1998, 74(Suppl. 1):207-212.
33. Horowitz B., Prince A.M., Hamman J., Watklevicz C. Viral safety of solvent/detergent-treated blood products. Blood Coagul Fibrinol 1994, 5(Suppl 3):S21-S28.
34. Johnston A., Macgregor A., Borovec S., Hattarki M., Stuckly K., Anderson D., et al. Inactivation and clearance of viruses during the manufacture of high Purity factor IX. Biologicals 2000, 29:129-136.
35. Tomokiyo K., Yano H., Imamura M., Nakano Y., Nakagaki T., Ogata Y., et al. Large-scale production and properties of human plasma-derived activated Factor VII concentrate. Vox Sang 2003, 84:54-64.
36. Furuya K., Murai K., Yokoyama T., Maeno H., Takeda Y., Murozuka T., et al. Implementation of a 20-nm pore-size filter in the plasma-derived Factor VIII manufacturing process. Vox Sang 2006, 91:119-125.
37. Zhou J.X., Solamo F., Hong T., Shearer M., Tressel T. Viral clearance using disposable systems in monoclonal antibody commercial downstream processing. Biotechnol Bioeng 2008, 100:488-496.
38. ®20N. J Membr Sci 2006, 278:3-9.
39. Soluk L, Price H, Sinclair C, Atalla-Mikhail D, Genereux M. Pathogen safety of intravenous Rh immunoglobulin liquid and other immune globulin products: enhanced nanofiltration and manufacturing process overview. Am J Ther;15:435-443.
40. Omar A., Kempf C. Removal of neutralized model parvoviruses and enteroviruses in human IgG solutions by nanofiltration. Transfusion 2002, 42:1005-1010.
41. Kreil T.R., Wieser A., Berting A., Spruth M., Medek C., Pölsler G., et al. Removal of small nonenveloped viruses by antibody-enhanced nanofiltration during the manufacture of plasma derivatives. Transfusion 2006, 46:1143-1151.
42. Troccoli N.M., McIver J., Losikoff A., Poiley J. Removal of viruses from human intravenous immune globulin by 35 nm nanofiltration. Biologicals 1998, 26:321-329.
43. Burnouf T., Radosevich M. Nanofiltration of plasma-derived biopharmaceutical products. Haemophilia 2003, 9:24-37.