Liquid composition comprising factor viii or factor viii/von willebrand factor complex
AssigneeGrifols Worldwide Operations Limited
InventorsToshiharu MOTOKUBOTA, Zong-zhi HUANG, Emma PELEGRI-O'DAY, Steven W. HERRING
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Abstract
A liquid composition comprising Factor VIII or Factor VIII/von Willebrand Factor complex comprising one or more stabilizers selected from glycerol, sorbitol, sucrose, trehalose, betaine, proline, arginine, histidine, NaCl, calcium, surfactants, antithrombin III, heparin, and albumin, wherein the content of proteases is 30 ng/1,000 FVIII IU or less, wherein osmolality of said composition is between 350 and 800 mOsmol/kg.
Claims20
1-19. (canceled)
A liquid composition comprising Factor VIII (FVIII) or Factor VIII/von Willebrand Factor (FVIII/VWF) complex comprising one or more stabilizers selected from glycerol, sorbitol, sucrose, trehalose, betaine, proline, arginine, histidine, NaCl, calcium, surfactants, antithrombin III, heparin, and albumin, wherein the content of proteases is 30 ng/1,000 FVIII IU or less, wherein osmolality of said composition is between 350 and 800 mOsmol/kg.
A process for obtaining a liquid composition comprising Factor VIII (FVIII) or a Factor VIII/von Willebrand Factor (FVIII/VWF) complex comprising the steps of:
- a) Obtaining a purified or partially purified FVIII or FVIII/VWF complex-containing liquid bulk;
- b) Treating said bulk with an affinity resin to remove proteases;
- c) Adding stabilizers to yield a more stable FVIII or FVIII/VWF complex-containing solution;
- and
- d) Storing the composition obtained in step c) at a temperature between 5° C. and 30° C.
Dependencies are inferred from the claim text.