Title:
PURIFICATION OF BISPECIIFC ANTIBODIES
Document Type and Number:
WIPO Patent Application WO/2021/208839
Kind Code:
A1
Abstract:
Provided is a process of purifying a bispecific antibody comprising a TCR constant domain from a fluid comprising said bispecific antibody and potential impurities, wherein said process comprises subjecting said fluid to a Protein A chromatography followed by an anion exchange chromatography and a mixed-mode chromatography in the specified order, thereby to obtain a harvest of purified bispecific antibody; wherein the anion exchange chromatography is conducted in bind-elute mode.
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Inventors:
LI YIFENG (CN)
WANG YING (CN)
GUO GAILI (CN)
HAN JINYU (CN)
WANG YING (CN)
GUO GAILI (CN)
HAN JINYU (CN)
Application Number:
PCT/CN2021/086488
Publication Date:
October 21, 2021
Filing Date:
April 12, 2021
Export Citation:
Assignee:
WUXI BIOLOGICS SHANGHAI CO LTD (CN)
WUXI BIOLOGICS IRELAND LTD (IE)
WUXI BIOLOGICS IRELAND LTD (IE)
International Classes:
C07K1/18; C07K1/22; C07K16/18; C07K19/00
Domestic Patent References:
| WO2019057122A1 | 2019-03-28 | |||
| WO2017218977A2 | 2017-12-21 |
Foreign References:
| CN109535257A | 2019-03-29 | |||
| CN110272496A | 2019-09-24 |
Other References:
YIFENG LI: "Effective strategies for host cell protein clearance in downstream processing of monoclonal antibodies and Fc-fusion proteins", PROTEIN EXPRESSION AND PURIFICATION, ACADEMIC PRESS, SAN DIEGO, CA., vol. 134, 1 June 2017 (2017-06-01), SAN DIEGO, CA. , pages 96 - 103, XP055525637, ISSN: 1046-5928, DOI: 10.1016/j.pep.2017.04.006
GUO GAILI, JINYU HAN, YING WANG, YIFENG LI: "A potential downstream platform approach for WuXiBody-based IgG-like bispecific antibodies", PROTEIN EXPRESSION AND PURIFICATION, vol. 173, 23 April 2020 (2020-04-23), XP055859166, DOI: 10.1016/j.pep.2020.105647
LI YIFENG, YING WANG, PETER (KEQIANG) SHEN, WEICHANG ZHOU: "Chapter 8 - A roadmap for IgG-like bispecific antibody purification", APPROACHES TO THE PURIFICATION, ANALYSIS AND CHARACTERIZATION OF ANTIBODY-BASED THERAPEUTICS, 1 January 2020 (2020-01-01), pages 167 - 179, XP055859168, DOI: 10.1016/B978-0-08-103019-6.00008-4
GUO GAILI, JINYU HAN, YING WANG, YIFENG LI: "A potential downstream platform approach for WuXiBody-based IgG-like bispecific antibodies", PROTEIN EXPRESSION AND PURIFICATION, vol. 173, 23 April 2020 (2020-04-23), XP055859166, DOI: 10.1016/j.pep.2020.105647
LI YIFENG, YING WANG, PETER (KEQIANG) SHEN, WEICHANG ZHOU: "Chapter 8 - A roadmap for IgG-like bispecific antibody purification", APPROACHES TO THE PURIFICATION, ANALYSIS AND CHARACTERIZATION OF ANTIBODY-BASED THERAPEUTICS, 1 January 2020 (2020-01-01), pages 167 - 179, XP055859168, DOI: 10.1016/B978-0-08-103019-6.00008-4
Attorney, Agent or Firm:
SHANGHAI PATENT & TRADEMARK LAW OFFICE, LLC (CN)
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