Mixed Bed Ion Exchange Adsorber

Abstract

The present invention refers to new species of an ion exchange adsorber which is suitable for the separation of host cell proteins (HCPs), antibody fragments and low molecular weight substances from solutions containing antibodies. The invention especially refers to a process for purifying biological samples by separating biomolecules of interest and impurities, comprising steps of contacting a sample with said chromatography media consisting of fibers, said fibers having imparted thereon functionality enabling ion exchange chromatography and/or hydrophobic interaction.

What is claimed: 
     
         1 . A process for purifying a biological sample by separating a biomolecule of interest and impurities, comprising the steps of
 contacting the sample with a chromatography media consisting of fibers, said fibers having imparted thereon functionality enabling ion exchange chromatography and/or hydrophobic interaction and   steps of washing either to remove unbound species or to extract said biomolecule of interest.   
     
     
         2 . A process according to  claim 1  for purifying a sample comprising a biomolecule of interest and impurities, comprising the steps of:
 a) providing a sample, 
 b) contacting said sample with a first chromatography media comprising fibers, said fibers having imparted thereon functionality enabling ion-exchange chromatography or hydrophobic interaction chromatography, 
 c) washing said first fiber media to remove unbound species, 
 d) washing said first fiber media to extract said biomolecule of interest, 
 e) contacting said biomolecule of interest with a second chromatography media comprising fibers, said fibers having imparted thereon functionality enabling ion-exchange chromatography or hydrophobic interaction chromatography, 
 f) washing said second fiber media to remove unbound species, and 
 g) washing said second fiber media to extract said biomolecule of interest, 
 
       but with the proviso that differently functionalized fiber media are used in steps b) and e). 
     
     
         3 . A process according to  claim 2 , wherein in step b) said sample is contacted with a first chromatography media comprising fibers, said fibers having imparted functionality enabling anion-exchange chromatography, and wherein in step e) chromatography media are used comprising fibers having functionality enabling hydrophobic interaction chromatography. 
     
     
         4 . A process according to  claim 2 , wherein in step b) said sample is contacted with a first chromatography media comprising fibers, said fibers having imparted functionality enabling cation-exchange chromatography, and wherein in step e) chromatography media are used comprising fibers having functionality enabling hydrophobic interaction chromatography. 
     
     
         5 . A process according to  claim 2 , wherein in step b) chromatography media are used comprising fibers having functionality enabling hydrophobic interaction chromatography, and wherein said ion-exchange chromatography in step e) is anion-exchange chromatography. 
     
     
         6 . A process according to  claim 2 , wherein in step b) chromatography media are used comprising fibers having functionality enabling hydrophobic interaction chromatography, and wherein said ion-exchange chromatography in step e) is cation-exchange chromatography. 
     
     
         7 . The process of  claim 2 , wherein said first chromatography media in step b) is anion-exchange chromatography, and wherein said second chromatography media in step e) is cation-exchange chromatography. 
     
     
         8 . The process of  claim 2 , wherein said first chromatography media in step b) is cation-exchange chromatography, and wherein said second chromatography media in step e) is anion-exchange chromatography. 
     
     
         9 . A process for purifying a sample comprising a biomolecule of interest and impurities, comprising the steps:
 a) providing a sample,   b) contacting said sample with a mixture of a first chromatography media comprising fibers and a second chromatography media comprising fibers, said first chromatography media comprising fibers having imparted thereon functionality enabling ion exchange chromatography, said second chromatography media comprising fibers having imparted thereon functionality enabling ion exchange chromatography,   c) washing said mixture of chromatography media to remove unbound species, and   d) washing said mixture of chromatography media to extract said biomolecule of interest.   
     
     
         10 . The process of  claim 9 , wherein said first chromatography media is anion-exchange chromatography and said second chromatography media is cation-exchange chromatography or vice versa. 
     
     
         11 . A process for purifying a sample comprising a biomolecule of interest and impurities, comprising the steps:
 a) providing a sample,   b) contacting said sample with a mixture of a first chromatography media comprising fibers and a second chromatography media comprising fibers, said first chromatography media comprising fibers having imparted thereon functionality enabling hydrophobic interaction chromatography, said second chromatography media comprising fibers having imparted thereon functionality enabling ion exchange chromatography,   c) washing said mixture of chromatography media to remove unbound species, and   d) washing said mixture of chromatography media to extract said biomolecule of interest.   
     
     
         12 . The process of  claim 11 , wherein said second chromatography media is cation-exchange chromatography or anion-exchange chromatography. 
     
     
         13 . A housing comprising a packed bed of fibers; said packed bed having a first layer and a second layer, said first layer comprising fibers having imparted thereon functionality enabling ion-exchange chromatography, and said second layer comprising fibers having imparted thereon functionality enabling hydrophobic interaction chromatography. 
     
     
         14 . The housing of  claim 13 , wherein said ion-exchange chromatography is anion-exchange chromatography or cation-exchange chromatography. 
     
     
         15 . A housing comprising a packed bed of fibers; said packed bed having a first layer and a second layer, said first layer comprising fibers having imparted thereon functionality enabling hydrophobic interaction chromatography, and said second layer comprising fibers having imparted thereon functionality enabling ion-exchange chromatography. 
     
     
         16 . The housing of  claim 15 , wherein said ion-exchange chromatography is anion-exchange chromatography or cation-exchange chromatography. 
     
     
         17 . A housing comprising a packed bed of fibers; said packed bed having a mixture of a first chromatography media and a second chromatography media, said first chromatography media comprising fibers having imparted thereon functionality enabling hydrophobic interaction chromatography, and said second chromatography media comprising fibers having imparted thereon functionality enabling ion-exchange chromatography. 
     
     
         18 . The housing of  claim 17 , wherein said ion-exchange chromatography is anion-exchange chromatography or cation-exchange chromatography. 
     
     
         19 . A process for purifying a sample comprising a biomolecule of interest and impurities, comprising; providing a sample, contacting said sample with a first chromatography media comprising fibers, said first fibers having imparted thereon functionality enabling ion-exchange chromatography and a second chromatography media comprising fibers, said second fibers having imparted thereon functionality enabling ion-exchange chromatography. 
     
     
         20 . The process of  claim 19 , wherein said first chromatography media are cation-exchange fibers and said second chromatography media are anion-exchange fibers. 
     
     
         21 . The process of  claim 19 , wherein said first chromatography media are anion-exchange fibers and said second chromatography media are cation-exchange fibers. 
     
     
         22 . The process of  claim 19 , wherein said first functionality enables purification in a flow-through mode and said second functionality enables purification in a flow-through mode. 
     
     
         23 . The process of  claim 19 , wherein said first functionality enables purification in a bind/elute mode and said second functionality enables purification in a bind/elute mode. 
     
     
         24 . The process of  claim 19 , wherein said first functionality enables purification in a flow-through mode and said second functionality enables purification in a bind/elute mode. 
     
     
         25 . A process for purifying a sample comprising a biomolecule of interest and impurities, comprising; providing a sample, contacting said sample with a first chromatography media comprising fibers, said first fibers having imparted thereon functionality enabling ion-exchange chromatography and a second chromatography media comprising fibers, said second fibers having imparted thereon functionality enabling hydrophobic interaction chromatography. 
     
     
         26 . The process of  claim 25 , wherein said first chromatography media are cation-exchange fibers and said second chromatography media are hydrophobic interaction chromatography fibers. 
     
     
         27 . The process of  claim 25 , wherein said first chromatography media are anion-exchange fibers and said second chromatography media are hydrophobic interaction chromatography fibers. 
     
     
         28 . The process of  claim 25 , wherein said first functionality enables purification in a flow-through mode and said second functionality enables purification in a flow-through mode. 
     
     
         29 . The process of  claim 25 , wherein said first functionality enables purification in a bind/elute mode and said second functionality enables purification in a bind/elute mode. 
     
     
         30 . The process of  claim 25 , wherein said first functionality enables purification in a flow-through mode and said second functionality enables purification in a bind/elute mode. 
     
     
         31 . The process of  claim 19 , wherein said first chromatography media and said second chromatography media are arranged in a mixture. 
     
     
         32 . The process of  claim 19 , wherein said first chromatography media and said second chromatography media are arranged in layers. 
     
     
         33 . The process of  claim 25 , wherein said first chromatography media and said second chromatography media are arranged in a mixture. 
     
     
         34 . The process of  claim 25 , wherein said first chromatography media and said second chromatography media are arranged in layers.