Method for purification of immunoglobulin

Patent metadata

Field	Value
Publication number	US-11535646-B2
Application number	US-201816758653-A
Country	US
Kind code	B2
Filing date	Oct 26, 2018
Priority date	Oct 27, 2017
Publication date	Dec 27, 2022
Grant date	Dec 27, 2022

Abstract

The present invention relates to an improved method of purifying an immunoglobulin, and more particularly to a method of purifying an immunoglobulin which is capable of sufficiently removing impurities from an immunoglobulin-containing plasma protein sample through a simple process, comprising a single anion-exchange chromatography and a single cation-exchange chromatography.

First claim

The invention claimed is:

1. A method of purifying an immunoglobulin, the method comprising:
(a) subjecting an immunoglobulin-containing plasma sample to anion-exchange chromatography to obtain a fraction that is not attached to an anion-exchange chromatography column; and
(b) subjecting the obtained fraction to cation-exchange chromatography,
wherein the cation-exchange chromatography of process (b) above comprises eluting the immunoglobulin at a salt concentration of 200 mM to 300 mM, and
wherein, after process (b) above, additional ion-exchange chromatography is not performed.

2. The method according to claim 1 , wherein the immunoglobulin-containing plasma sample is obtained using a method comprising:
(i) dissolving immunoglobulin-containing plasma protein fraction I+II+III or fraction II+III, and then performing a precipitation reaction by adding a precipitant; and
(ii) removing the precipitate and obtaining an immunoglobulin-containing supernatant.

3. The method according to claim 2 , wherein the precipitant of process (i) above is caprylic acid.

4. The method according to claim 1 , wherein the anion-exchange chromatography of process (a) above is performed at a pH ranging from 5.8 to 6.2.

5. The method according to claim 1 , wherein the cation-exchange chromatography of process (b) above comprises eluting the immunoglobulin using a sodium chloride-containing buffer.

6. The method according to claim 1 , further comprising, between processes (a) and (b) above, inactivating virus by adding a surfactant.

7. The method according to claim 1 , wherein an immunoglobulin having a purity of 96% or more is obtained by the method.

8. The method according to claim 1 , wherein the method does not further comprise, after process (b) above, a pH adjustment process, a precipitation process, or a solvent or detergent treatment process.

Assignees

• Green Cross Corp

Inventors

• Kim Soo-Kwang
• Boo Kyung Hyun
• Seo Kang Yun
• Choi Sung Min
• Yoon Jeong Hye
• Park Jin Hyun
• Kim Yeon Hui

Classifications

• C07K1/18 Primary

  Ion-exchange chromatography · CPC title

• C07K1/36

  by a combination of two or more processes of different types · CPC title

• C07K1/30

  by precipitation · CPC title

• C07K1/34

  by filtration, ultrafiltration or reverse osmosis · CPC title

• A61K39/39525

  Purification · CPC title