Process for the preparation of a composition containing factor VIII

Preparation of a non-immunogenic composition (I) containing Factor VIII (F8) comprises: (a) treatment of a solution of F8 with tri-(n-butyl) phosphate (TNBP) and detergent, and (b) heat treatment of a freeze-dried material containing F8 at 100 degrees C for 15-120 minutes, such that the residual moi...

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Bibliographische Detailangaben
Hauptverfasser: KLOFT, MICHAEL, LOEBNAU, WOLFGANG, BUCCI, ENZO, RUDNICK, DIETER, OTT, GUENTER, KOTITSCHKE, RONALD, DICHTELMUELLER, HERBERT
Format: Patent
Sprache:eng ; fre ; ger
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Zusammenfassung:Preparation of a non-immunogenic composition (I) containing Factor VIII (F8) comprises: (a) treatment of a solution of F8 with tri-(n-butyl) phosphate (TNBP) and detergent, and (b) heat treatment of a freeze-dried material containing F8 at 100 degrees C for 15-120 minutes, such that the residual moisture content after the heat treatment is 0.3-1.8 wt.%. Also claimed is (I).