IP Library Granted Patent US 9,815,050
Granted Patent B2
US 9,815,050 · App. 14/682,456 · Granted Nov 14, 2017

Chromatography media and method

Inventors: David Yavorsky (Bolton, MA); John Amara (Reading, MA); Joaquin Umana (Stoneham, MA); William Cataldo (Bradford, MA); Mikhail Kozlov (Lexington, MA); Matthew Stone (Cambridge, MA)
Assignee: EMD Millipore Corporation
B01J39/26B01D15/327B01D15/361B01D15/362B01D15/363B01D15/3804B01J20/285B01J20/287B01J20/28023B01J20/28059B01J20/3244B01J41/20B01J47/014B01J47/127C07K1/18C07K16/00C12N7/00C12N7/02Y10S502/52724Y10T428/2938Y10T428/2973
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Quick Facts
Patent No.
US 9,815,050
App. No.
14/682,456
Granted
Nov 14, 2017
Kind
B2
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).

Claims (18)

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.

Assignments (1)
CHANGE OF ADDRESS Recorded Feb 1, 2018
From: EMD MILLIPORE CORPORATION
To: EMD MILLIPORE CORPORATION
Reel/Frame 045225/0156 →
Continuity (3)
Continuation 13191992 · Jul 27, 2011
Provisional Application 61369331 · Jul 30, 2010
Related Publication 20150258540A1 · Sep 17, 2015