Patent ID: 6893856

Claim:
A process for preparing a virus-inactivated plasma component, wherein the component is factor IX, factor X, or a mixture of factors IX and X, comprising the steps of: a) applying a source of the plasma component to a solid phase for extraction, the solid phase having anion exchanger materials immobilized thereon, under conditions effecting extraction by adsorption of the plasma component on the solid phase; b) applying a desorbing solution to the solid phase, the solution having an ionic strength that effects elution of the plasma component from the solid phase in a resulting eluate comprising the plasma component in the desorbing solution; followed by; c) isolation and purification of the plasma component by i) applying eluate from the solid phase to a chromatography membrane having immobilized thereon anion exchanger materials, under conditions effecting selective adsorption of the plasma component on the chromatography membrane, and eluting tbe plasma component from the chromatography membrane, ii) applying eluate from the anion-exchange membrane chromatography to a chromatography membrane having immobilized thereon a ligand having particular affinity for the plasma component to effect adsorption of the plasma component on the chromatography membrane, iii) stepwise elution from the affinity-chromatography membrane by applying a solvent system employing a gradient of increasing ionic strength; different polarities, or different pH values to isolate the plasma component in a solvent-containing fraction; or d) removing solvent from the fraction to concentrate the plasma component, therein; and e) effecting virus-inactivation by treating i) the eluate from the solid-phase chromatography, prior to applying the eluate to a chromatography membrane, or ii) the fraction containing the plasma component, obtained by the stepwise elution from the chromatography membrane, with detergents in the presence of di- or trialkyl phosphate compounds.