METHOD FOR SEPARATION OF IMMUNOGLOBULIN MONOMER

Title:

METHOD FOR SEPARATION OF IMMUNOGLOBULIN MONOMER

Document Type and Number:

WIPO Patent Application WO/2008/156124

Kind Code:

A1

Abstract:

[PROBLEMS] To provide: a method for separating an immunoglobulin monomer with a high degree of accuracy by subjecting an immunoglobulin solution comprising at least the immunoglobulin monomer and an aggregate thereof to the cross-flow filtration through an ultrafiltration membrane; and an ultrafiltration membrane module and a cross-flow filtration apparatus for use in the method. [MEANS FOR SOLVING PROBLEMS] An immunoglobulin monomer can be separated by subjecting an immunoglobulin solution comprising at least the immunoglobulin monomer and an aggregate thereof and having an immunoglobulin concentration of 1 to 150 g/L to the cross-flow filtration through an ultrafiltration membrane having a cut-off molecular weight of not smaller than 100,000 and smaller than 500,000. In this manner, the immunoglobulin monomer can be passed at a passing rate of 80% or more and with such a fractionation performance that the ratio of the passing rate of an immunoglobulin dimer passing through the ultrafiltration membrane to the passing rate of the immunoglobulin monomer passing through the ultrafiltration membrane is 0.20 or less.

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Inventors:

YAMAGUCHI FUMIHIKO (JP)
MIZOMOTO HITOSHI (JP)
HAMASAKI SHINYA (JP)
MOCHIZUKI TAKENA (JP)

Application Number:

PCT/JP2008/061164

Publication Date:

December 24, 2008

Filing Date:

June 18, 2008

Export Citation:

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Assignee:

ASAHI CHEMICAL IND (JP)
YAMAGUCHI FUMIHIKO (JP)
MIZOMOTO HITOSHI (JP)
HAMASAKI SHINYA (JP)
MOCHIZUKI TAKENA (JP)

International Classes:

C07K16/00; A61K39/395; B01D61/14; B01D61/22; B01D61/58; B01D63/02; B01D69/08; B01D71/10; B01D71/26; B01D71/32; B01D71/44; B01D71/68; C07K1/34; C08G75/23

Domestic Patent References:

WO2007018284A1	2007-02-15
WO2002013859A1	2002-02-21

Foreign References:

JP2003012693A	2003-01-15
JPS5659716A	1981-05-23
JPH10265406A	1998-10-06

Other References:

LITZEN A. ET AL.: "Separation and quantitation of monoclonal antibody aggregates by asymmetrical flow field-flow fractionation and comparison to gel permeation chromatography", ANAL. BIOCHEM., vol. 212, no. 2, 1993, pages 469 - 480, XP024763578

Attorney, Agent or Firm:

MOEGI PATENT OFFICE (Minato-ku Tokyo, 01, JP)

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