Title:
LIQUID PREPARATION OF HUMANIZED ANTIBODY FOR TREATING IL-6-RELATED DISEASE
Document Type and Number:
WIPO Patent Application WO/2019/105450
Kind Code:
A1
Abstract:
The present invention relates to a liquid preparation of a humanized antibody for treating an IL-6-related disease. The liquid preparation comprises 2-100 mg/ml of a recombinant humanized anti-human interleukin 6 receptor monoclonal antibody, 5-20 mM of a histidine salt buffer solution (or a buffer solution of a combination of 5-20 mM of a histidine salt and 5-20 mM of sodium acetate), 0.025-0.075% (volume ratio) of a surfactant, and 3-5% (mass-to-volume ratio) of a stabilizer and water for injection. The antibody preparation enhances the stability of the recombinant anti-human interleukin 6 receptor monoclonal antibody, prevents aggregation and degradation of the monoclonal antibody, and acid isomer increase. The preparation is applicable in stabilizing the structure and function of the humanized antibody.
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Inventors:
LIN JIAN (CN)
LIU FAN (CN)
YUE RUI (CN)
WU ZHIHAO (CN)
WANG SHENGWU (CN)
LI SHENGFENG (CN)
LIU FAN (CN)
YUE RUI (CN)
WU ZHIHAO (CN)
WANG SHENGWU (CN)
LI SHENGFENG (CN)
Application Number:
PCT/CN2018/118503
Publication Date:
June 06, 2019
Filing Date:
November 30, 2018
Export Citation:
Assignee:
BIO THERA SOLUTIONS LTD (CN)
International Classes:
A61K9/00; A61K39/395; A61K47/18; C07K16/24; C07K16/28
Domestic Patent References:
| WO2017155990A1 | 2017-09-14 | |||
| WO2017147293A1 | 2017-08-31 |
Foreign References:
| CN102869346A | 2013-01-09 | |||
| US20100247523A1 | 2010-09-30 | |||
| CN101939425A | 2011-01-05 | |||
| CN103476793A | 2013-12-25 | |||
| CN107406491A | 2017-11-28 |
Other References:
"Pharmacopoeia of the People's Republic of China", vol. 4, 2015, article "Insoluble Microparticle Test"
WOOD ET AL., J IMMUNOL., vol. 145, 1990, pages 3011
JOSEF S SMOLENROBERT LANDEWEFERDINAND C BREEDVELD ET AL.: "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update [J", ANN. RHEUM. DIS., vol. 0, 2013, pages 1 - 18
GO WOON KIM ET AL.: "IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future [J]", ARCH. PHARM. RES, vol. 38, 2015, pages 575 - 584, XP035501352, DOI: 10.1007/s12272-015-0569-8
VEALE DJFEARON U: "Inhibition of angiogenic pathways in rheumatoid arthritis: potential for therapeutic targeting [J", BEST PRACT. RES. CLIN. RHEUMATO., vol. 20, 2006, pages 941 - 947, XP005652466, DOI: 10.1016/j.berh.2006.05.004
XU SDTANG FISHI L ET AL.: "Anti-Saantibody in Chinese Rheumatoid arthritis [J", CHINESE MED. J., vol. 111, no. 3, 1998, pages 204 - 207
RITCHIE DMBOYLE JAMCLNNES JM ET AL.: "Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis[J]", Q. J. MED, vol. 37, 1986, pages 393 - 406
WOOD ET AL., J IMMUNOL., vol. 145, 1990, pages 3011
JOSEF S SMOLENROBERT LANDEWEFERDINAND C BREEDVELD ET AL.: "EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update [J", ANN. RHEUM. DIS., vol. 0, 2013, pages 1 - 18
GO WOON KIM ET AL.: "IL-6 inhibitors for treatment of rheumatoid arthritis: past, present, and future [J]", ARCH. PHARM. RES, vol. 38, 2015, pages 575 - 584, XP035501352, DOI: 10.1007/s12272-015-0569-8
VEALE DJFEARON U: "Inhibition of angiogenic pathways in rheumatoid arthritis: potential for therapeutic targeting [J", BEST PRACT. RES. CLIN. RHEUMATO., vol. 20, 2006, pages 941 - 947, XP005652466, DOI: 10.1016/j.berh.2006.05.004
XU SDTANG FISHI L ET AL.: "Anti-Saantibody in Chinese Rheumatoid arthritis [J", CHINESE MED. J., vol. 111, no. 3, 1998, pages 204 - 207
RITCHIE DMBOYLE JAMCLNNES JM ET AL.: "Clinical studies with an articular index for the assessment of joint tenderness in patients with rheumatoid arthritis[J]", Q. J. MED, vol. 37, 1986, pages 393 - 406
Attorney, Agent or Firm:
BEIJING WANHUIDA LAW FIRM (CN)
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