Prefilter System for Biological Systems

Abstract

The present invention is to a prefilter for affinity chromatography columns. The prefilter, positioned upstream of the column inlet, reduces the presence of non-specific binding (NSB) species that enter the system, thereby extending the yield, capacity and lifetime of the column. Suitable agents include but are not limited to hydrophobic entities; lipophilic entities; activated carbon; charged cation or anion entities; ligands; particles such as fumed silica, glass, controlled pore glass or derivitized version of each; silica or silicates; and combinations thereof. The material(s) can be incorporated into a variety of media such as fibers, beads, membranes and the like and then incorporated into a variety of device designs including lenticular pads, depth filters, bead containing columns, spiral wound devices, TFF devices and the like.

1 . (canceled) 
     
     
         2 . A protein purification system comprising a tangential fluid flow (TFF) prefilter device upstream of and in fluid communication with an affinity chromatography column or an ultrafiltration system, the TFF prefilter device comprising one or more layers of fibrous media or bead media selected to remove non-specific binding (NSB) constituents from a protein-containing stream before entering the affinity chromatography column or ultrafiltration system. 
     
     
         3 . The protein purification system of  claim 2 , wherein the media comprises a material selected from the group consisting of hydrophobic entities, lipophilic entities, activated carbon, charged cation or anion entities, ligands, particles such as fumed silica, glass, controlled pore glass and derivitized version of each, silica or silicates, and a combination thereof. 
     
     
         4 . The protein purification system of  claim 2  further comprising a storage tank placed in fluid communication between an outlet of the prefilter and an inlet of the affinity chromatography column or the ultrafiltration system. 
     
     
         5 . A method of removing non-specific binding (NSB) constituents from a protein-containing stream comprising flowing a protein-containing stream through a protein purification system comprising a tangential fluid flow (TFF) prefilter device upstream of and in fluid communication with an affinity chromatography column or an ultrafiltration system, the TFF prefilter device comprising one or more layers of fibrous media selected to remove NSB constituents from the protein-containing stream, thereby removing NSB constituents from the protein-containing stream before the protein-containing stream enters the affinity chromatography column or ultrafiltration system. 
     
     
         6 . The method of  claim 5 , wherein the media comprises a material selected from the group consisting of hydrophobic entities, lipophilic entities, activated carbon, charged cation or anion entities, ligands, particles such as fumed silica, glass, controlled pore glass and derivitized version of each, silica or silicates, and combinations thereof. 
     
     
         7 . The method of  claim 5 , further comprising storing the protein-containing stream through a storage tank placed in fluid communication between an outlet of the prefilter and an inlet of the affinity chromatography column or the ultrafiltration system. 
     
     
         8 . The method of  claim 5 , wherein the method is a batch mode method. 
     
     
         9 . The method of  claim 5 , wherein the method is a continuous mode method. 
     
     
         10 . A method of removing non-specific binding (NSB) constituents from a protein-containing stream comprising flowing a protein-containing stream through a protein purification system comprising a prefilter device upstream of and in fluid communication with an affinity chromatography column or an ultrafiltration system, the prefilter device comprising one or more layers of bead media selected to remove NSB constituents from the protein-containing stream, thereby removing NSB constituents from the protein-containing stream before the protein-containing stream enters the affinity chromatography column or ultrafiltration system. 
     
     
         11 . The method of  claim 10 , wherein the media comprises a material selected from the group consisting of hydrophobic entities, lipophilic entities, activated carbon, charged cation or anion entities, ligands, particles such as fumed silica, glass, controlled pore glass and derivitized version of each, silica or silicates, and combinations thereof. 
     
     
         12 . The method of  claim 10 , further comprising storing the protein-containing stream through a storage tank placed in fluid communication between an outlet of the prefilter and an inlet of the affinity chromatography column or the ultrafiltration system. 
     
     
         13 . The method of  claim 10 , wherein the method is a batch mode method. 
     
     
         14 . The method of  claim 10 , wherein the method is a continuous mode method.