Effect of manufacturing process parameters on virus inactivation by solvent-detergent treatment in a high-purity factor IX concentrate

Vox Sanguinis

Volumn 84, Issue 3, 2003, Pages 170-175

  Roberts, Peter L ^a   Dunkerley, C ^a  

^a BIO PRODUCTS LABORATORY   (United Kingdom)

Author keywords

Factor IX; Plasma products; Solvent detergent; Virus inactivation; Virus safety

Indexed keywords

BLOOD CLOTTING FACTOR 9 CONCENTRATE; DETERGENT; POLYSORBATE 80; SOLVENT; TRIBUTYL PHOSPHATE;

ANIMAL CELL; ARTICLE; CONCENTRATION (PARAMETERS); HERPES SIMPLEX VIRUS 1; LABORATORY TEST; NONHUMAN; PLASMA; PRIORITY JOURNAL; SEMLIKI FOREST ALPHAVIRUS; SINDBIS VIRUS; TEMPERATURE DEPENDENCE; VACCINIA VIRUS; VESICULAR STOMATITIS VIRUS; VIRUS INACTIVATION;

DETERGENTS; DRUG INDUSTRY; FACTOR IX; HUMANS; KINETICS; PHOSPHORIC ACID ESTERS; POLYSORBATES; SOLVENTS; STERILIZATION; TEMPERATURE; VIRUS DISEASES; VIRUSES;

EID: 0037398550     PISSN: 00429007     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.1423-0410.2003.00275.x     Document Type: Article

References (14)

1. Committee for Proprietary Medicinal Products, European Medicines Evaluation Agency: Note for Guidance on Plasma-Derived Medicinal Products. CPMP/BWP/269/95 Rev 3. London, European Agency for the Evaluation of Medicinal Products, 2001
2. Roberts P: Virus safety of plasma products. Rev Med Virol 1996; 6:25-38
3. Burnouf T: Safety aspects in the manufacturing of plasma-derived coagulation factor concentrates. Biologicals 1992; 20:91 100
4. Foster PR, Cuthbertson B: Procedures for the prevention of virus transmission by blood products; in Madhok R, Forbes D, Evatt BL (eds): Blood, Blood Products and HIV. London, Chapman Et Hall, 1994:207-248
5. Horowitz B, Prince AM, Horowitz MS, Watklevicz C: Virus safety of solvent-detergent treated blood products; in Brown F (ed.): Virological Safety Aspects of Plasma Derivatives. Developments in Biological Standardization, vol. 81. Basel, Karger, 1993:147-161
6. Horowitz B, Weibe ME, Lippin A, Stryker MH: Inactivation of viruses in labile blood derivatives. I. Disruption of lipid-enveloped viruses by tri (n-butyl) phosphate detergent combinations. Transfusion 1985; 25:516-522
7. Prince AM, Horowitz B, Brotman B: Sterilisation of hepatitis and HTLV-III viruses by exposure to tri (n-butyl) phosphate and sodium cholate. Lancet 1986; 1:706-710
8. Prince AM, Horowitz B, Brotman B, Huima T, Richardson L, van der Ende MC: Inactivation of hepatitis B and Hutchinson strain non-A, non-B viruses by exposure to Tween 80 and ether. Vox Sang 1984; 46:36-43
9. Feldman PA: Development and characterisation of the high-purity factor IX, Replenine. Haemophilia 1995; 1:12-15
10. Feldman P, Crombie D, Lowery K, Roberts P: Validation of virus-filtration using factor IX. Thromb Haemost (Suppl.) 1997; 506
11. Roberts P: Virological safety of the purified factor IX concentrate, Replenine. Haemophilia 1995; 1:19-22
12. Minor PD: Meeting on the acceptance criteria for virus validation studies. Biologicals 1995; 23:107-110
13. Roberts P: Resistance of vaccinia virus to inactivation by solvent/detergent treatment of blood products. Biologicals 2000; 28:29-32
14. Hiemstra H, Van Engelenburg F, Terpstra F, Schuitemaker H, Over J: Experimental designs as a basis for viral inactivation studies; in: Downstream, Abstracts of the Plasma Product Biotechnology Meeting 2001. Amersham, Amersham Biosciences, 2001