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Patent Searching and Data


Title:
METHODS FOR INCREASING THE CAPACITY OF FLOW-THROUGH PROCESSES
Document Type and Number:
WIPO Patent Application WO/2015/195453
Kind Code:
A4
Abstract:
In various embodiments, the present invention provides a process for separating target proteins from non-target proteins in a sample comprising increasing the concentration of the target proteins and non-target proteins in the sample and subsequently delivering the concentrated sample to a chromatography device. In other embodiments, the invention relates to a process for increasing the capacity of a chromatography device for a target protein by delivering a concentrated sample comprising the target protein to a chromatography device.

Inventors:
NATARAJAN VENKATESH (US)
LUTZ HERBERT (US)
RAGHUNATH BALA (US)
Application Number:
PCT/US2015/035251
Publication Date:
April 21, 2016
Filing Date:
June 11, 2015
Export Citation:
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Assignee:
EMD MILLIPORE CORP (US)
International Classes:
B01D61/14; A61L2/00; B01D15/12; C07K1/16; C07K1/34; C07K1/36; C07K16/06
Attorney, Agent or Firm:
CARROLL, Alice, O. et al. (Brook Smith & Reynolds, P.C.,530 Virginia Rd.,P.O. Box 913, Concord MA, US)
Download PDF:
Claims:
AMENDED CLAIMS

received by the International Bureau on 14 January 2016 (14.01.2016)

1. A process for separating target proteins from non-target proteins, comprising:

a) obtaining a liquid sample containing target proteins and non-target proteins;

b) increasing the concentration of the target proteins and non-target proteins in the

sample to produce a concentrated feed for delivery to a chromatography device;

c) delivering the concentrated feed to the chromatography device;

d) separating the target protems from the non-target proteins in the chromatography device; and

e) recovering the target proteins from the chromatography device.

2. The process of Claim 1 , wherein the concentration of the target proteins and non-target proteins in the sample is increased using a tangential flow filtration (TFF) process.

3. The process of Claim 2, wherein the TFF process is a single-pass TFF (SPTFF) process, a recirculating TFF process, or a TFF process operating in single-pass TFF mode where at least a portion of the retentate is recirculated after the first pass through the TFF system.

4. The process of Claim 1 or Claim 2, wherein the sample is diluted to produce a diluted feed, prior to increasing the concentration of the target proteins and non-target proteins in the sample in step b).

5. The process of Claim 1 or Claim 2, wherein the target proteins arc monoclonal antibodies.

6. The process of Claim 1 or Claim 2, wherein the non-target proteins are host cell proteins from hybridoma cells expressing the target protein.

7. The process of Claim 1 or Claim 2, wherein the chromatography device includes 1) an anion-exchange chromatography medium or a hydrophobic interaction chromatography medium; 2) a size-exclusion chromatography medium; 3) a salt-tolerant membrane adsorber; or 4) an affinity chromatography medium.

8. The process of Claim 1 or Claim 2, wherein the chromatography device is disposable.

9. A process for increasing the capacity of a chromatography device for a target protein, comprising: a) obtaining a liquid sample containing target proteins and non-target proteins; b) increasing the concentration of the target proteins and non-target proteins in the

sample to produce a concentrated feed for delivery to a chromatography device; and c) delivering the concentrated feed to the chromatography device,

wherein the capacity of the chromatography device for the target protein is increased,

10. The process of Claim 9, wherein the concentration of the target proteins and non-target proteins in the sample is increased using a tangential flow filtration (TFF) process.

1 1. The process of Claim 10, wherein the TFF process is a single-pass TFF (SPTFF) process, a recirculating TFF process or a TFF process operating in single-pass TFF mode where at least a portion of the retentate is recirculated after the first pass through the TFF system.

12. The process of Claim 9 or Claim 10, wherein the sample is diluted to produce a diluted feed, prior to increasing the concentration of the.target proteins and non-target proteins in the sample in step b).

13. The process of Claim 9 or Claim 10, wherein the target proteins are monoclonal

antibodies.

14. The process of Claim 9 or Claim 10, wherein the non-target proteins arc host cell proteins from hybridoma cells expressing the target protein.

15. The process of Claim 9 or Claim 10, wherein the chromatography device includes 1 ) an anion-exchange chromatography medium; 2) a hydrophobic interaction chromatography medium; 3) a size-exclusion chromatography medium; or 4) a salt-tolerant membrane adsorber.

16. The process of Claim 7, wherein the affinity chromatography medium is a protein A

medium, a protein G medium or an immobilized metal ion medium.

17. A process for filtering viruses from a liquid sample, comprising:

a) obtaining a liquid sample containing viruses;

b) increasing the protein concentration of the sample to produce a concentrated feed for delivery to a viral filtration device;

c) delivering the concentrated feed to the viral filtration device; and

d) removing viruses from the feed in the viral filtration device.

18. The process of Claim 17, wherein the protein concentration of the sample is increased using a tangential flow filtration (TFF) process. 19. The process of Claim 18, wherein the TFF process is a single-pass TFF (SPTFF) process, a recirculating TFF process or a TFF process operating in single-pass TFF mode where at least a portion of the rctcntatc is recirculated after the first pass through the TFF system. 20. The process of Claim 17 or Claim 18, wherein the viral filtration device includes a flux- limited filter. 21. The process of any one of the preceding claims, further comprising performing

continuous diafiltration or discontinuous diafiltration.