Highly purified factor VIII complex
AssigneeBaxter Aktiengesellschaft
InventorsWolfgang Schönhofer, Johann Eibl, Alfred Weber, Yendra Linnau
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Abstract
There is disclosed a highly purified complex comprising the components factor VIII and vWF having a specific activity of at least 70, preferably 100 to 300 U factor VIII:C/mg, a stable pharmaceutical preparation containing this complex as well as a method of producing the same.
Claims29
A method of fractionating a composition comprising factor VIII:C and von Willebrand factor (vWF), comprising
- contacting the composition with an immunoaffinity chromatography material;
- eluting factor VIII/vWF-complex with a first elution buffer;
- and then eluting non-complexed factor VIII:C or vWF with a second elution buffer, wherein the second elution buffer has a concentration or conductivity that is at least 20% higher than the first elution buffer, and wherein the collagen binding activity of the VIII/vWF complex is 0.2 to 0.6 of the collagen binding activity of vWF antigen.
A preparation comprising a highly purified complex of factor VIII:C and von Willebrand factor (vWF), wherein the complex can be obtained by contacting a starting material containing the factor VIII:C and vWF with an immunoaffinity chromatography material and eluting factor VIII/vWF-complex with an elution buffer, wherein the preparation is free from non-complexed vWF and factor VIII:C and has a specific activity of at least 70 U of factor VIII:C/mg, and wherein the collagen binding activity of the VIII/vWF complex is 0.2 to 0.6 of the collagen binding activity of vWF antigen.
Dependencies are inferred from the claim text.