Separation of plasma components

Abstract

A method for separating components from plasma, the method comprising (I) separating the plasma into a first and second component, the first component comprising an albumin / α-1-antirypsin pool and the second component comprising plasma containing components having a molecular mass greater than albumin; (II) treating the second component to form an immunoglobulins concentrate containing immunoglobulins substantially free from components having a molecular mass less than immunoglobulins; (III) treating the immunoglobulins concentrate to remove components having a molecular mass greater than immunoglobulins; and (IV) separating albumin and α-1-antitrypsin from the albumin / α-1-antitrypsin pool.

Description

TECHNICAL FIELD[0001]The present invention relates to the separation of biomolecules from plasma, particularly human plasma.BACKGROUND ART[0002]Human plasma contains approximately 3000 proteins with a variety of functions and potential therapeutic uses. Tight control of plasma available for blood fractionation means that the supply of important therapeutic agents like IgG is severly curtailed. This together with methodology which ends in very low yields and takes three to five days contributes to the international shortfall of major plasma fractions.[0003]The present inventors have found that rapid isolation times, high recoveries and high-resolution make Gradiflow™ technology a viable alternative purification technology to conventional Cohn precipitation and column chromatography [1, 2].[0004]Albumin and IgG both have enormous importance in medicine and therefore are of considerable commercial value. Albumin alone has an estimated annual global market value of $US1.5 billion [3]. C...

AI Technical Summary

Benefits of technology

"The present invention relates to a method for separating biomolecules from a plasma sample using a combination of four separation phases. The method involves placing the plasma in a first solvent stream and using a membrane to separate it from a second solvent stream. The first solvent stream has a molecular mass cut-off less than the molecular mass of albumin and α-1-antitrypsin, while the second solvent stream has a molecular mass cut-off less than the molecular mass of immunoglobulins. The method then involves optionally stopping and reversing the electric potential to cause movement of biomolecules having a molecular mass greater than immunoglobulins in the second solvent stream. The method can be used to remove large contaminants from the plasma sample and concentrate immunoglobulins."

Problems solved by technology

Tight control of plasma available for blood fractionation means that the supply of important therapeutic agents like IgG is severly curtailed.

This together with methodology which ends in very low yields and takes three to five days contributes to the international shortfall of major plasma fractions.

Conventional purification protocols are cumbersome and expensive with low yields and long processing times [4].

Conventional purification schemes use the Cohn ethanol precipitation method and result in only 50% recovery.

Conventional purification schemes utilise a combination of Cohn fractionation and column chromatography with the major difficulty being the removal of albumin from α-1-antitrypsin preparations [9].

Current production schemes provide a yield of approximately 30% and much of this is contaminated with albumin.

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