HIGH TEMPERATURE DEAD END ANTIBODY FILTRATION

• US 20150361131A1
• Filed: 12/30/2013
• Published: 12/17/2015
• Est. Priority Date: 12/28/2012
• Status: Abandoned Application

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Jensen, Ole E.
• Application Number:
  US14/655,401
• Publication Number:
  US 20150361131A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2039/55527 Interleukins
• CPC Class Codes: A61K 39/395 Antibodies agglutinins A61K38/36 ; as drug carriers A61K47/50; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
• CPC Class Codes: A61K 39/39591 Stabilisation, fragmentation
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: C07K 1/34 by filtration, ultrafiltration or reverse osmosis
• CPC Class Codes: C07K 16/06 from serum
• CPC Class Codes: C07K 16/065 Purification, fragmentation
• CPC Class Codes: C07K 16/244 Interleukins [IL]
• CPC Class Codes: C07K 16/38 against protease inhibitors of peptide structure

Abstract

The invention relates to a method of dead end filtration of a highly concentrated antibody containing solutions at a temperature above room temperature, wherein the filter flow rate is increased compared to filtration at a room temperature, the filter flow rate is kept constant and the yield increased compared to filtration at a room temperature.

Claims

1. A method of stabilising and/or increasing the flow rate during a dead end filtration of a highly concentrated solution containing an antibody and/or a fragment thereof, wherein the solution is heated to a temperature ranging from 30-70°

C. during and/or before filtration.

2. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the solution is heated to a temperature of at least 40°

C. during and/or before filtration

3. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the yield is increased compared to filtration at room temperature.

4. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the flow through the filter is constant during the filtration.

5. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the filter capacity is constant through the filtration.

6. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the flow rate through the filter is increased compared to filtration at a room temperature.

7. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the concentration of the antibody or fragment thereof in the concentrated solution is above 200 g/L.

8. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the solution is heated to a temperature of at least 45°

C. during and/or before filtration

9. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the solution is heated to a temperature of 40°

C. during and/or before filtration.

10. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the solution is heated to a temperature of 45°

C. during and/or before filtration

11. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the antibody is a monoclonal antibody.

12. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the antibody is an anti-IL-20 monoclonal antibody.

13. A method of stabilising and/or increasing the flow rate during a dead end filtration according to claim 1, wherein the antibody is an anti-TFPI monoclonal antibody.