Title:
ANTI-HER2 MONOCLONAL ANTIBODY LYOPHILIZED PREPARATION AND PREPARATION METHOD
Document Type and Number:
WIPO Patent Application WO/2021/259101
Kind Code:
A1
Abstract:
A stable anti-HER2 monoclonal antibody lyophilized preparation and a preparation method. The defect of a protein solution being unstable is greatly improved by means of optimizing the formula and lyophilization processes of the preparation. A drug produced by means of the formula and the preparation method of the lyophilized preparation has a stability of at least 6 months at 25℃ and a stability of at least 60 months at 5°C.
Inventors:
YANG SIXING (CN)
ZHANG SHIRONG (CN)
SU YAN (CN)
HUANG HAOMIN (CN)
ZHU ZHENPING (CN)
ZHANG SHIRONG (CN)
SU YAN (CN)
HUANG HAOMIN (CN)
ZHU ZHENPING (CN)
Application Number:
PCT/CN2021/100338
Publication Date:
December 30, 2021
Filing Date:
June 16, 2021
Export Citation:
Assignee:
SUNSHINE GUOJIAN PHARMACEUTICAL SHANGHAI CO LTD (CN)
International Classes:
C07K16/30; A61K39/395; A61P35/00; C12N15/13
Domestic Patent References:
| WO2020025013A1 | 2020-02-06 | |||
| WO2018136412A2 | 2018-07-26 | |||
| WO2011012637A2 | 2011-02-03 |
Foreign References:
| CN110732023A | 2020-01-31 | |||
| CN102416176A | 2012-04-18 | |||
| CN102309754A | 2012-01-11 | |||
| CN101199483A | 2008-06-18 |
Other References:
FU WENYAN: "Construction,Optimization and Characterizat of Novel anti-HER2 Antibody for Cancer Therapy", MASTER THESIS, CHINESE PEOPLE'S LIBERATION ARMY MEDICAL COLLEGE, CN, 27 May 2015 (2015-05-27), CN , pages 1 - 85, XP009525268
AGARKHED MEERA; O’DELL COURTNEY; HSIEH MING-CHING; ZHANG JINGMING; GOLDSTEIN JOEL; SRIVASTAVA ARVIND: "Effect of Surfactants on Mechanical, Thermal, and Photostability of a Monoclonal Antibody", AAPS PHARMSCITECH, SPRINGER US, NEW YORK, vol. 19, no. 1, 2 August 2017 (2017-08-02), New York , pages 79 - 92, XP036412843, DOI: 10.1208/s12249-017-0845-7
AGARKHED MEERA ET AL: "Effect of polysorbate 80 concentration on thermal and photostability of a monoclonal antibody.", AAPS PHARMSCITECH, SPRINGER NEW YORK LLC, US, vol. 14, no. 1, 14 November 2012 (2012-11-14), US , pages 1 - 9, XP002729469, ISSN: 1530-9932, DOI: 10.1208/s12249-012-9878-0
COBLEIGH MELODY A; VOGEL CHARLES L; TRIPATHY DEBU; ROBERT NICHOLAS J; SCHOLL SUSY; FEHRENBACHER LOUIS; WOLTER JANET M; PATON VIRGI: "Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY, US, vol. 17, no. 9, 1 September 1999 (1999-09-01), US , pages 2639 - 2648, XP009124967, ISSN: 0732-183X
CLELAND J L,ET AL: "A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 90, no. 3, 1 March 2001 (2001-03-01), US , pages 310 - 321, XP002397269, ISSN: 0022-3549, DOI: 10.1002/1520-6017(200103)90:3<310::AID-JPS6>3.0.CO;2-R
AGARKHED MEERA; O’DELL COURTNEY; HSIEH MING-CHING; ZHANG JINGMING; GOLDSTEIN JOEL; SRIVASTAVA ARVIND: "Effect of Surfactants on Mechanical, Thermal, and Photostability of a Monoclonal Antibody", AAPS PHARMSCITECH, SPRINGER US, NEW YORK, vol. 19, no. 1, 2 August 2017 (2017-08-02), New York , pages 79 - 92, XP036412843, DOI: 10.1208/s12249-017-0845-7
AGARKHED MEERA ET AL: "Effect of polysorbate 80 concentration on thermal and photostability of a monoclonal antibody.", AAPS PHARMSCITECH, SPRINGER NEW YORK LLC, US, vol. 14, no. 1, 14 November 2012 (2012-11-14), US , pages 1 - 9, XP002729469, ISSN: 1530-9932, DOI: 10.1208/s12249-012-9878-0
COBLEIGH MELODY A; VOGEL CHARLES L; TRIPATHY DEBU; ROBERT NICHOLAS J; SCHOLL SUSY; FEHRENBACHER LOUIS; WOLTER JANET M; PATON VIRGI: "Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease", JOURNAL OF CLINICAL ONCOLOGY, AMERICAN SOCIETY OF CLINICAL ONCOLOGY, US, vol. 17, no. 9, 1 September 1999 (1999-09-01), US , pages 2639 - 2648, XP009124967, ISSN: 0732-183X
CLELAND J L,ET AL: "A specific molar ratio of stabilizer to protein is required for storage stability of a lyophilized monoclonal antibody", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 90, no. 3, 1 March 2001 (2001-03-01), US , pages 310 - 321, XP002397269, ISSN: 0022-3549, DOI: 10.1002/1520-6017(200103)90:3<310::AID-JPS6>3.0.CO;2-R
Attorney, Agent or Firm:
J.Z.M.C. PATENT AND TRADEMARK LAW OFFICE (CN)
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