Inactivation of Hepatitis A Virus by Pasteurization and Elimination of Picornaviruses during Manufacture of Factor VIII Concentrate

Vox Sanguinis ◽  
1994 ◽  
Vol 67 (1) ◽  
pp. 62-66
Author(s):  
J. Hilfenhaus ◽  
T. Nowak
Keyword(s):  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus

“In vitro” and in Animal Model Studies on a Double Virus- Inactivated Factor VIII Concentrate

1995 ◽  
Vol 74 (03) ◽  
pp. 868-873 ◽  
Author(s):  
Silvana Arrighi ◽  
Roberta Rossi ◽  
Maria Giuseppina Borri ◽  
Vladimir Lesnikov ◽  
Marina Lesnikov ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Animal Model ◽  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Virus Inactivation ◽  
Enveloped Viruses ◽  
Model Studies ◽  
Heat Treated

SummaryTo improve the safety of plasma derived factor VIII (FVIII) concentrate, we introduced a final super heat treatment (100° C for 30 min) as additional virus inactivation step applied to a lyophilized, highly purified FVIII concentrate (100 IU/mg of proteins) already virus inactivated using the solvent/detergent (SID) method during the manufacturing process.The efficiency of the super heat treatment was demonstrated in inactivating two non-lipid enveloped viruses (Hepatitis A virus and Poliovirus 1). The loss of FVIII procoagulant activity during the super heat treatment was of about 15%, estimated both by clotting and chromogenic assays. No substantial changes were observed in physical, biochemical and immunological characteristics of the heat treated FVIII concentrate in comparison with those of the FVIII before heat treatment.

Detection of Hepatitis A Virus in a Factor VIII Preparation by Antigen Capture/PCR

Vox Sanguinis ◽  
1994 ◽  
Vol 67 (1) ◽  
pp. 57-61 ◽  
Author(s):  
Andrea Normann ◽  
Judith Graff ◽  
Bertram Flehmig
Keyword(s):  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Antigen Capture

Detection of Hepatitis A Virus in a Factor VIII Preparation by Antigen Capture/PCR

Vox Sanguinis ◽  
1994 ◽  
Vol 67 ◽  
pp. 57-61 ◽  
Author(s):  
Andrea Normann ◽  
Judith Graff ◽  
Bertram Flehmig
Keyword(s):  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Antigen Capture

Sequence Variability of Hepatitis A Virus and Factor VIII Associated Hepatitis A Infections in Hemophilia Patients in Europe: An Update

Vox Sanguinis ◽  
1994 ◽  
Vol 67 ◽  
pp. 39-46 ◽  
Author(s):  
Betty H. Robertson ◽  
Devorah Friedberg ◽  
Daniel Shouval ◽  
Andrea Normann ◽  
Judith Graff ◽  
...  
Keyword(s):  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Sequence Variability

Detection of hepatitis A virus RNA in commercially available factor VIII preparation

The Lancet ◽  
1992 ◽  
Vol 340 (8829) ◽  
pp. 1232-1233 ◽  
Author(s):  
A. Normann ◽  
J. Graff ◽  
A. Gerritzen ◽  
H.-H. Brackmann ◽  
B. Flehmig
Keyword(s):  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Virus Rna

scholarly journals Hepatitis A Virus Infection in Tamarins: Experimental Transmission via Contaminated Factor VIII Concentrates

2002 ◽  
Vol 185 (8) ◽  
pp. 1170-1173 ◽  
Author(s):  
Michael Chudy ◽  
Christiane Stahl‐Hennig ◽  
Annemarie Berger ◽  
C. Micha Nübling ◽  
Gerhard Hunsmann ◽  
...  
Keyword(s):  
Virus Infection ◽  
Factor Viii ◽  
Hepatitis A ◽  
Hepatitis A Virus ◽  
Experimental Transmission ◽  
Factor Viii Concentrates

scholarly journals Inhibitors in German Hemophilia A Patients Treated with a Double Virus Inactivated Factor VIII Concentrate Bind to the C2 Domain of FVIII Light Chain

1999 ◽  
Vol 81 (01) ◽  
pp. 39-44 ◽  
Author(s):  
R. Laub ◽  
Di Giambattista ◽  
P. Fondu ◽  
H.-H. Brackmann ◽  
H. Lenk ◽  
...  
Keyword(s):  
Factor Viii ◽  
Heavy Chain ◽  
Light Chain ◽  
Hepatitis A ◽  
Hemophilia A ◽  
Hepatitis A Virus ◽  
C2 Domain ◽  
Epitope Specificity ◽  
Previously Treated ◽  
Inhibitor Titer

SummaryTo reduce the risk of transmission of hepatitis A virus, an Octaphar-ma produced factor VIII (fVIII) concentrate treated with solvent detergent (FVIII-SD) was further pasteurized after purification. This product, Octavi SDPlus (FVIII-SDP), was marketed in Europe in 1993 to 1995. Inhibitors appeared from September to October, 1995, in 12 of 109 previously treated German hemophilia A patients. A study of similarly treated Belgian patients, who also developed inhibitors, had shown antibodies to the fVIII light chain (domains A3-C1-C2) only. In the present study, the epitope specificity of 8 German inhibitor plasmas was also found to be restricted to the light chain. In radioimmunoprecipitation assays to localize the light chain epitope(s), antibody binding to heavy chain (domains A1-A2-B) was 11-148 fold lower than to the C2 domain, and binding to recombinant A3-C1 was barely detectable. These results were supported by >95% neutralization of a high responder inhibitor titer by the C2 domain.

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