Chromatography media and method

Patent metadata

Field	Value
Publication number	US-9815050-B2
Application number	US-201514682456-A
Country	US
Kind code	B2
Filing date	Apr 9, 2015
Priority date	Jul 30, 2010
Publication date	Nov 14, 2017
Grant date	Nov 14, 2017

Abstract

Adsorptive media for chromatography, particularly ion-exchange chromatography, derived from a shaped fiber. In certain embodiments, the functionalized shaped fiber presents a fibrillated or ridged structure which greatly increases the surface area of the fibers when compared to ordinary fibers. Also disclosed herein is a method to add surface pendant functional groups that provides cation-exchange or anion-exchange functionality to the high surface area fibers. This pendant functionality is useful for the ion-exchange chromatographic purification of biomolecules, such as monoclonal antibodies (mAbs).

First claim

What is claimed is:

1. A process for purifying a sample comprising a biomolecule, comprising contacting said sample with a bed of fiber media, said fibers having a cross-section comprising a body region defining a substantially longitudinal axis, and having a plurality of projections extending outwardly from said body region, said fibers having imparted thereon functionality enabling ion-exchange chromatography.

2. The process of claim 1 , wherein said bed of fiber media is an axially compressed bed of cut nylon staple fiber media, and wherein said functionality is anion exchange functionality that enables purification in a flow through mode.

3. The process of claim 1 , wherein said functionality enables purification in a bind/elute mode.

4. A process of purifying a sample comprising a biomolecule of interest and impurities, comprising:
providing a sample comprising the biomolecule of interest and impurities;
contacting said sample with a chromatography media comprising an axially compressed bed of cut nylon staple fibers, said fibers having a cross-section comprising a region comprising a body region defining a substantially longitudinal axis, and a plurality of projections extending outwardly from said body region, said fibers having imparted thereon anion-exchange functionality, acrylic polymer functionality or cation-exchange functionality thereby to bind the biomolecule of interest or impurities; and
recovering the biomolecule of interest.

5. The process of claim 4 , wherein the biomolecule of interest is bound to the chromatography media, and is recovered by elution.

6. The process of claim 4 , wherein the impurities are bound to the chromatography media, and the biomolecule of interest is recovered in a flow-through mode.

7. The process of claim 1 , wherein said biomolecule comprises a monoclonal antibody.

8. A process for purifying a negatively-charged virus, comprising providing a sample containing negatively-charged virus; contacting said sample containing said negatively-charged virus with an axially compressed bed of cut nylon staple fiber media, wherein said cut fibers have a cross-section comprising a body region defining a substantially longitudinal axis, and have a plurality of projections extending outwardly from said body region, and wherein said fibers have imparted thereon a polymeric functionality, wherein the surfaces of said polymeric functionality are modified with pendant trimethylammonium groups; washing said fibers to remove unbound species; and eluting said negatively-charged virus, thereby to purify the negatively-charged virus; wherein said negatively charged virus is bacteriophage ø6.

9. A process for removing a negatively-charged virus from a sample, comprising providing a sample containing negatively-charged virus; contacting said sample containing said negatively-charged virus with an axially compressed bed of cut nylon staple fiber media, wherein said cut fibers have a cross-section comprising a body region defining a substantially longitudinal axis, and have a plurality of projections extending outwardly from said body region, said fibers having imparted thereon a polymeric functionality, wherein the surfaces of said polymeric functionality are modified with pendant trimethylammonium groups, thereby binding said negative-charged virus to said fibers, washing said fibers to remove unbound species; and eluting said negatively-charged virus; wherein said negatively charged virus is bacteriophage ø6.

10. The process of claim 1 , wherein said fibers are packed in a container at a density of between 0.1 and 0.5 g/ml and are randomly oriented.

11. The process of claim 4 , wherein said fibers are packed in a container at a density of between 0.1 and 0.5 g/ml and are randomly oriented.

12. The process of claim 8 , wherein said fibers are packed in a container at a density of between 0.1 and 0.5 g/ml and are randomly oriented.

13. The process of claim 9 , wherein said fibers are packed in a container at a density of between 0.1 and 0.5 g/ml and are randomly oriented.

14. The process of claim 8 , wherein said fibers are epoxy-functionalized fibers modified with trimethylamine.

15. The process of claim 9 , wherein said fibers are epoxy-functionalized fibers modified with trimethylamine.

Assignees

• Emd Millipore Corp

Inventors

• Yavorsky David
• Amara John
• Umana Joaquin
• Cataldo William
• Kozlov Mikhail
• Stone Matthew

Classifications

• B01D15/361 Primary

  Ion-exchange · CPC title

• B01J20/28023

  Fibres or filaments (fibres or filaments in the form of membranes B01J20/28038; B01J20/28007 takes precedence) · CPC title

• C12N7/02

  Recovery or purification · CPC title

• B01J20/285

  based on polymers · CPC title

• C07K1/16

  by chromatography · CPC title