Multistep final filtration

Patent metadata

Field	Value
Publication number	US-11891430-B2
Application number	US-201916660635-A
Country	US
Kind code	B2
Filing date	Oct 22, 2019
Priority date	Oct 1, 2009
Publication date	Feb 6, 2024
Grant date	Feb 6, 2024

Abstract

Herein is reported a method for the final filtration of concentrated polypeptide solutions comprising the combination of two immediately consecutive filtration steps with a first filter of 3.0 μm and 0.8 μm pore size and a second filter of 0.45 μm and 0.22 μm pore size.

First claim

What is claimed is:

1. A method for producing an immunoglobulin solution comprising
a) providing an immunoglobulin solution with a concentration of at least 100 g/l, and
b) applying the immunoglobulin solution to a combination of a first and second filter unit, whereby the first filter unit comprises a pre-filter with a pore size of 3.0 μm and a main-filter with a pore size of 0.8 μm and the second filter unit comprises a pre-filter with a pore size of 0.45 μm and a main-filter with a pore size of 0.22 μm with a pressure of from 0.1 to 4.0 bar, and thereby producing an immunoglobulin solution.

2. A method for producing an immunoglobulin comprising the following steps
a) cultivating a cell comprising a nucleic acid encoding an immunoglobulin,
b) recovering the immunoglobulin from the cell or the cultivation medium,
c) purifying the immunoglobulin with one or more chromatography steps, and providing an immunoglobulin solution,
d) optionally adding a sugar, an amino acid and/or a detergent to the solution,
e) concentrating the immunoglobulin solution to a concentration of 100 g/l or more with a method selected from diafiltration or tangential-flow filtration, and
f) applying the immunoglobulin solution of the previous step to a combination of a first and second filter unit, whereby the first filter unit comprises a pre-filter with a pore size of 3.0 μm and a main-filter with a pore size of 0.8 μm and the second filter unit comprises a pre-filter with a pore size of 0.45 μm and a main-filter with a pore size of 0.22 μm with a pressure of from 0.1 to 4.0 bar, and thereby producing an immunoglobulin.

3. The method of claim 1 wherein the filter in the first and second filter unit have about the same filter area.

4. The method of claim 1 wherein the immunoglobulin solution has a concentration of from 100 g/l to 300 g/l.

5. The method of claim 1 wherein the immunoglobulin solution has a volume of from 3 liter to 100 liter.

6. The method of claim 1 wherein the immunoglobulin is an anti-IL13 receptor alpha antibody or an anti-HER2 antibody.

7. The method of claim 1 wherein the producing includes protein A affinity chromatography step and at least one step selected from cation exchange chromatography, anion exchange chromatography, and hydrophobic interaction chromatography.

8. The method of claim 1 wherein the immunoglobulin solution has a concentration of 160 g/l or more and the applying to the combination of filters is by applying a pressure of 1.45 bar or more.

9. The method of claim 1 wherein the immunoglobulin solution comprises a sugar and a surfactant and has a concentration of 125 mg/ml or more and the applying to the combination of the filter is by applying a pressure of 0.75 bar or less.

10. The method of claim 2 wherein the filter in the first and second filter unit have about the same filter area.

11. The method of claim 2 wherein the immunoglobulin solution has a concentration of from 100 g/l to 300 g/l.

12. The method of claim 2 wherein the immunoglobulin solution has a volume of from 3 liter to 100 liter.

13. The method of claim 2 wherein the immunoglobulin is an anti-IL13 receptor alpha antibody or an anti-HER2 antibody.

14. The method of claim 2 wherein the purifying is with a protein A affinity chromatography step and at least one step selected from cation exchange chromatography, anion exchange chromatography, and hydrophobic interaction chromatography.

15. The method of claim 2 wherein the immunoglobulin solution has a concentration of 160 g/l or more and the applying to the combination of filters is by applying a pressure of 1.45 bar or more.

16. The method of claim 2 wherein the immunoglobulin solution comprises a sugar and a surfactant and has a concentration of 125 mg/ml or more and the applying to the combination of the filter is by applying a pressure of 0.75 bar or less.

Assignees

• Hoffmann La Roche

Inventors

• Falkenstein Roberto
• Schwendner Klaus

Classifications

• C07K16/065 Primary

  Purification, fragmentation · CPC title

• C07K16/2866

  against receptors for cytokines, lymphokines, interferons · CPC title

• C07K16/32

  against translation products of oncogenes · CPC title

• C07K1/16

  by chromatography · CPC title

• C07K1/34

  by filtration, ultrafiltration or reverse osmosis · CPC title