Title:
METHOD FOR PREPARING CONCENTRATED SOLUTION COMPRISING MONOCLONAL ANTIBODY AGAINST HUMAN INTERLEUKIN-33 AND LIQUID PREPARATION
Document Type and Number:
WIPO Patent Application WO/2023/077685
Kind Code:
A1
Abstract:
Disclosed in the present application is a liquid preparation of a monoclonal antibody against human interleukin-33, which liquid preparation comprises a monoclonal antibody against human interleukin-33 with a protein concentration of 120-300 mg/mL and an amino acid additive with an amino acid concentration of 10-500 mM, wherein the monoclonal antibody against human interleukin-33 comprises three heavy chain complementarity determining regions (CDR-H1, CDR-H2 and CDR-H3) and three light chain complementarity determining regions (CDR-L1, CDR-L2 and CDR-L3), CDR-H1 has an amino acid sequence as shown in SEQ ID NO: 1, CDR-H2 has an amino acid sequence as shown in SEQ ID NO: 2, CDR-H3 has an amino acid sequence as shown in SEQ ID NO: 3, CDR-L1 has an amino acid sequence as shown in SEQ ID NO: 4, CDR-L2 has an amino acid sequence as shown in SEQ ID NO: 5, and CDR-L3 has an amino acid sequence as shown in SEQ ID NO: 6. Further disclosed is a method for preparing a concentrated solution of the monoclonal antibody against human interleukin-33. The liquid preparation of the present application has low viscosity and high stability and can be used as an injection.
Inventors:
XUE GANG (CN)
ZHU HUAJIE (CN)
DAI CHANGSONG (CN)
LI SHUAI (CN)
XU QIN (CN)
GUO CAIMING (CN)
CHEN WEI (CN)
WU YILIANG (CN)
ZHU HUAJIE (CN)
DAI CHANGSONG (CN)
LI SHUAI (CN)
XU QIN (CN)
GUO CAIMING (CN)
CHEN WEI (CN)
WU YILIANG (CN)
Application Number:
PCT/CN2022/075787
Publication Date:
May 11, 2023
Filing Date:
February 10, 2022
Export Citation:
Assignee:
QYUNS THERAPEUTICS CO LTD (CN)
International Classes:
C07K1/34; A61K9/08; A61K39/395; A61K47/18; A61K47/22; A61K47/26; A61P11/00; A61P11/02; A61P11/06; A61P35/00; A61P37/02; C07K1/14; C07K1/18; C07K1/22; C07K1/36; C07K16/24
Foreign References:
| CN113842457A | 2021-12-28 | |||
| CN114014929A | 2022-02-08 | |||
| CN113603775A | 2021-11-05 | |||
| CN113573733A | 2021-10-29 | |||
| CN113527490A | 2021-10-22 | |||
| CN111944046A | 2020-11-17 | |||
| IN201617025035A |
Other References:
XIAOLING ZHUANG, CUI YIQING, ZHANG XUELIAN: "Research on the preparation process of high-concentration antibody", BIOLOGICAL CHEMICAL ENGINEERING, vol. 6, no. 6, 25 December 2020 (2020-12-25), XP093062308
OKRAGLY ANGELA J, CORWIN KATIE BRANNON, ELIA MARIKKA, HE DONGMEI, SCHROEDER OLIVER, ZHANG QING, SHIYANOVA TATIYANA, BRIGHT STUART,: "Generation and Characterization of Torudokimab (LY3375880): A Monoclonal Antibody That Neutralizes Interleukin-33", JOURNAL OF INFLAMMATION RESEARCH, vol. 14, 1 August 2021 (2021-08-01), pages 3823 - 3835, XP093062330, DOI: 10.2147/JIR.S320287
NEAL WHITAKER, XIONG JIAN, PACE SAMANTHA E., KUMAR VINEET, MIDDAUGH C. RUSSELL, JOSHI SANGEETA B., VOLKIN DAVID B.: "A Formulation Development Approach to Identify and Select Stable Ultra–High-Concentration Monoclonal Antibody Formulations With Reduced Viscosities", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 106, no. 11, 1 November 2017 (2017-11-01), US , pages 3230 - 3241, XP055449627, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2017.06.017
OKRAGLY ANGELA J, CORWIN KATIE BRANNON, ELIA MARIKKA, HE DONGMEI, SCHROEDER OLIVER, ZHANG QING, SHIYANOVA TATIYANA, BRIGHT STUART,: "Generation and Characterization of Torudokimab (LY3375880): A Monoclonal Antibody That Neutralizes Interleukin-33", JOURNAL OF INFLAMMATION RESEARCH, vol. 14, 1 August 2021 (2021-08-01), pages 3823 - 3835, XP093062330, DOI: 10.2147/JIR.S320287
NEAL WHITAKER, XIONG JIAN, PACE SAMANTHA E., KUMAR VINEET, MIDDAUGH C. RUSSELL, JOSHI SANGEETA B., VOLKIN DAVID B.: "A Formulation Development Approach to Identify and Select Stable Ultra–High-Concentration Monoclonal Antibody Formulations With Reduced Viscosities", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 106, no. 11, 1 November 2017 (2017-11-01), US , pages 3230 - 3241, XP055449627, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2017.06.017
Attorney, Agent or Firm:
BEIJING TANGSONG IP FIRM (CN)
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