Process for manufacturing factor VIII having an improved ratio of FVIII:C/FVIII/AG
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United States of America Patent
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Nov 3, 2020
Grant Date -
Nov 24, 2016
app pub date -
Jan 20, 2015
filing date -
Jan 20, 2014
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Abstract
A process for manufacturing of a Factor VIII product having a ratio of FVIII:C/FVIII:Ag of at least 0.7 in the Factor VIII product by using chromatography wherein at least one chromatographic step is performed by means of employing; An affinity chromatography resin having an affinity for specifically binding of Factor VIII which is effected by an affinity ligand which is immobilised on the affinity chromatography resin, said affinity ligand is a 13 kD yeast derived Fab antibody fragment directed to the Factor VIII molecule. An anionic chromatography resin. A size exclusion resin. A Factor VIII product obtainable according to the process with a monomer content of >98% for treatment of haemophilia and avoiding formation of inhibitors.
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