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Title:
ハイドロキシアパタイトクロマトグラフィーを用いた二重特異性抗体および二重特異性抗体生産副産物の分離法
Document Type and Number:
Japanese Patent JP6560673
Kind Code:
B2
Abstract:
The present invention is directed to methods comprising the use of hydroxyapatite chromatography to separate a bispecific antibody from a solution that also comprises one or more byproducts specific to bispecific antibody production. Byproducts specific to the production of bispecific antibodies (bispecific antibody specific byproducts, “BASB”) include fragments of the bispecific antibody and heavier molecular weight variants of the antibody, wherein the fragment and/or variant comprises an Fc domain but does not exhibit affinity for the two different epitopes and/or antigens as exhibited by the desired bispecific antibody. Thus, the methods of the present invention comprise the separation of a bispecific antibody from one or more of its BASB. The hydroxyapatite chromatography methods of the invention may be used alone or may be further combined with standard purification processes and unit operations as is known in the art to achieve any level of purity of bispecific antibody necessary, e.g., for therapeutic and/or diagnostic applications.

Inventors:
Bartle Sabine
Dur Harald
Schaubmer Andrea
Application Number:
JP2016535445A
Publication Date:
August 14, 2019
Filing Date:
August 18, 2014
Export Citation:
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Assignee:
F. HOFFMANN-LA ROCHE AKTIENGESELLSCHAFT
International Classes:
C07K1/18
Domestic Patent References:
JP2013526848A
JP2013523104A
JP2012519708A
Foreign References:
WO2012024400A1
WO2013088259A1
Other References:
生物物理化学,1989年,Vol.33,p.39-45
Journal of chromatography,1992年,Vol.599,p.13-20
New Biotechnology,2009年,Vol.25,p.287-293
PNAS,2011年,Vol.108,p.11187-11192
Attorney, Agent or Firm:
Hatsushi Shimizu
Masao Haruna
Hirotaka Yamaguchi
Toshi Gobe
Ryuichi Inoue
Toshimitsu Sato
Koichi Niimi
Tomohiko Kobayashi
Masato Ozeki
Yoshihiro Igarashi
Kazuya Kawamoto