Methods and Devices for the Enrichment of Immunoglobulin from Blood

Abstract

In some embodiments, the invention provides a method for extracting at least 55% of immunoglobulin such as IgG present in a biological fluid from the biological fluid, comprising contacting a biological fluid suspected of containing immunoglobulin with a solid support covalently bonded to a ligand that specifically binds to immunoglobulin under conditions sufficient for non-covalent binding of immunoglobulin to the ligand; and contacting the solid support with an elution solution under condition whereby the noncovalently bound immunoglobulin is released from the ligand and into the elution solution, wherein at least 55% of the IgG present in the biological fluid is extracted into the elution solution. In some embodiments, the invention provides a method for enriching immunoglobulin from a biological fluid comprising obtaining an initial biological fluid suspected of containing immunoglobulin and removing non-immunoglobulin components naturally occurring in the initial biological fluid to obtain a non-immunoglobulin componentreduced biological fluid.

1 . A method for extracting at least 55% of immunoglobulin, such as IgG, present in a biological fluid from the biological fluid comprising:
 (a) contacting a biological fluid suspected of containing the immunoglobulin with a solid support covalently bonded to a ligand that specifically binds to the immunoglobulin under conditions sufficient for non-covalent binding of immunoglobulin in the biological fluid to the ligand; and   (b) contacting the solid support with an elution solution under condition whereby the non-covalently bound immunoglobulin is released from the ligand and into the elution solution,   wherein at least 55% of the immunoglobulin present in the biological fluid is extracted into the elution solution.   
     
     
         2 . The method of  claim 1 , comprising repeating step (a) at least once prior to step (b). 
     
     
         3 . The method of  claim 1 , wherein the extracted immunoglobulin in the elution solution is purified immunoglobulin. 
     
     
         4 . The method of  claim 1 , wherein at least 75% of the immunoglobulin in the biological fluid is extracted from the biological fluid. 
     
     
         5 . The method of  claim 1 , wherein step (a) comprises passing the biological fluid through a container comprising the solid support. 
     
     
         6 . (canceled) 
     
     
         7 . The method of  claim 5 , wherein the solid support is an inner surface of the container. 
     
     
         8 . The method of  claim 1 , wherein the solid support are beads. 
     
     
         9 . The method of  claim 8 , wherein the beads have an individual diameter of between about 30 um to about 80 um. 
     
     
         10 . The method of  claim 1 , wherein the ligand is a protein from a bacteria family selected from the group consisting of  Staphylococcus  or  Streptococcus , or a derivative thereof. 
     
     
         11 . The method of  claim 1 , further comprising adding a neutralizing buffer to the elution solution comprising the extracted immunoglobulin to result in a final solution comprising the immunoglobulin having a pH of between about 7.0 and about 8.0. 
     
     
         12 . The method of  claim 1 , wherein the elution solution has a pH of between about 2.0 and about 3.0. 
     
     
         13 . The method of  claim 5 , wherein the biological fluid passing through the container has a flow rate of between about 20 ml/minute to about 120 ml/minute. 
     
     
         14 . The method of  claim 5 , wherein the biological fluid passing through the container has a backpressure of between about 10 mm Hg to about 100 mmHg. 
     
     
         15 . The method of  claim 5 , wherein the container has a capacity to bind to at least 90% of the immunoglobulin present in the biological fluid prior to step (a). 
     
     
         16 . (canceled) 
     
     
         17 . The method of  claim 8 , wherein the beads are contained within a container, the container being a bag comprising a mesh lining an inner surface of the bag, wherein the beads are contained between the inner surface of the bag and the mesh lining. 
     
     
         18 - 19 . (canceled) 
     
     
         20 . The method of  claim 1 , wherein the immunoglobulin is IgG. 
     
     
         21 . A method for enriching immunoglobulin such as IgG from an initial biological fluid, comprising obtaining an initial biological fluid suspected of containing immunoglobulin and contacting the initial biological fluid with a solid support covalently bonded to a ligand that specifically binds to a non-immunoglobulin component in the initial biological fluid under conditions sufficient for non-covalent binding of non-immunoglobulin component in the initial biological fluid to the ligand, and removing the bound non-immunoglobulin components to obtain a non-immunoglobulin component-reduced biological fluid enriched for immunoglobulin. 
     
     
         22 - 27 . (canceled) 
     
     
         28 . A container configured for use in a plasmapheresis machine, the container comprising a solid support covalently bonded a ligand that specifically binds to a target molecule selected from the group consisting of an IgG molecule, a non-IgG molecule, an immunoglobulin, and a non-immunoglobulin molecule, wherein the container is configured to support a biological fluid passing through the container at a flow rate of between about 20 ml/minute to about 120 ml/minute. 
     
     
         29 - 31 . (canceled) 
     
     
         32 . A bag configured for used in an apheresis system, such as a plasmapheresis system or a plateletpheresis system, the bag comprising an inner surface and a mesh lining on the inner surface thereby creating a pocket on the inner surface, wherein beads covalently bonded to ligand that specifically binds to a target molecule selected from the group consisting of an IgG molecule, a non-IgG molecule, an immunoglobulin, and a non-immunoglobulin molecule, are located within the pocket. 
     
     
         33 . An apheresis system configured to extract at least 55% of immunoglobulin such as IgG present in a biological fluid using a container comprising a solid support covalently bonded to a ligand that specifically binds to immunoglobulin, in a method comprising (a) contacting a biological fluid suspected of containing immunoglobulin, with the solid support covalently bonded to the ligand that specifically binds to immunoglobulin in the container under conditions sufficient for non-covalent binding of immunoglobulin to the ligand; and (b) contacting the solid support in the container with an elution solution under condition whereby the non-covalently bound immunoglobulin is released from the ligand and into the elution solution to obtain elution solution comprising immunoglobulin. 
     
     
         34 . An apheresis system configured to enrich at least 55% of immunoglobulin (e.g., IgG) present in a biological fluid using a container comprising a solid support covalently bonded to a ligand that specifically binds to a non-immunoglobulin component in the biological fluid, in a method comprising (a) contacting a biological fluid suspected of containing immunoglobulin with the solid support in the container under conditions sufficient for non-covalent binding of the non-immunoglobulin component to the ligand; and (b) collecting the non-immunoglobulin depleted biological fluid from the container, the non-immunoglobulin depleted biological fluid being enriched for immunoglobulin. 
     
     
         35 - 46 . (canceled)