Gradipore Limited

Life Therapeutics Limited

Thomas Norman Turton

Brendon Conlan

Elizabeth Jean Seabrook

Chenicheri Hariharan Nair

May Lazar

Tracey Ann Edgell

The claims describe methods for isolating functionally active Factor VIII using a membrane-based separation system containing a separation membrane to create a first and second interstitial volume between at least two restriction membranes. One or more stabilizing agents are added to the sample and/or an interstitial volume. A solvent in the first interstitial volume maintains FVIII in a desired charge state. Applying a potential between the first and second interstitial volumes separates FVIII on one side of the separation membrane from unwanted molecules on the other side of the separation membrane. These methods may also be used as a substitute for one or more steps in a conventional purification scheme for the separation of native or recombinant FVIII.

Factor VIII separation

A method of removing a biological contaminant from a mixture containing a biomolecule and the biological contaminant, the method comprising: (a) placing the biomolecule and contaminant mixture in a first solvent stream, the first solvent stream being separated from a second solvent stream by an electrophoretic membrane; (b) selecting a buffer for the first solvent stream having a required pH; (c) applying an electric potential between the two solvent streams causing movement of the biomolecule through the membrane into the second solvent stream while the biological contaminant is substantially retained in the first sample stream, or if entering the membrane, being substantially prevented from entering the second solvent stream; (d) optionally, periodically stopping and reversing the electric potential to cause movement of any biological contaminants having entered the membrane to move back into the first solvent stream, wherein substantially not causing any biomolecules that have entered the second solvent stream to re-enter first solvent stream; and (e) maintaining step (c), and optional step (d) if used, until the second solvent stream contains the desired purity of biomolecule.

Removal of biological contaminants

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Lane Cove, Australia

Thomas Norman Turton