Title:
ANTI-HUMAN α9 INTEGRIN ANTIBODY-CONTAINING PHARMACEUTICAL COMPOSITION
Document Type and Number:
WIPO Patent Application WO/2019/065979
Kind Code:
A1
Abstract:
Provided is a stable pharmaceutical composition containing an anti-human α9 integrin antibody that suppresses the production of multimers, degradation products, insoluble impurities, or insoluble microparticles. The pharmaceutical composition contains a pharmaceutically acceptable buffer, and the pH is 5.0-7.0.
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Inventors:
MORISHIGE TOMOHIRO (JP)
KAWANO HIROKI (JP)
KAWANO HIROKI (JP)
Application Number:
PCT/JP2018/036289
Publication Date:
April 04, 2019
Filing Date:
September 28, 2018
Export Citation:
Assignee:
ASTELLAS PHARMA INC (JP)
International Classes:
A61K39/395; A61K9/08; A61K9/19; A61K47/02; A61K47/10; A61K47/12; A61K47/18; A61K47/22; A61K47/24; A61K47/26; A61P19/02; A61P29/00; A61P37/06; A61P37/08
Domestic Patent References:
| WO2009088064A1 | 2009-07-16 |
Other References:
UCHIYAMA, SUSUMU: "Biophysical Characterization of Biopharmaceuticals, Including Antibody Drugs", YAKUGAKU ZASSHI, vol. 136, no. 3, 2016, pages 443 - 448, XP055585649, ISSN: 0031-6903
UCHIYAMA, SUSUMU ET AL.: "Solution Properties of Antibody Pharmaceuticals", JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, vol. 74, no. 1, 2014, Japan, pages 12 - 18, XP055585653, ISSN: 0372-7629
IZUTSU, KENICHI: "An Introduction to Freeze-Drying of Protein Pharmaceuticals", JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, vol. 72, no. 6, 2012, Japan, pages 353 - 358, XP055585661, ISSN: 0372-7629
LIU, H. ET AL.: "Heterogeneity of monoclonal antibodies", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 97, no. 7, July 2008 (2008-07-01), pages 2426 - 2447, XP002530921, ISSN: 0022-3549, DOI: doi:10.1002/JPS.21180
MAITY, H. ET AL.: "Effects of arginine on photostability and thermal stability of lgG1 monoclonal antibodies", CURRENT PHARMACEUTICAL BIOTECHNOLOGY, vol. 10, no. 8, 2009, pages 761 - 766, XP009148288, ISSN: 1389-2010
UCHIYAMA, SUSUMU ET AL.: "Solution Properties of Antibody Pharmaceuticals", JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, vol. 74, no. 1, 2014, Japan, pages 12 - 18, XP055585653, ISSN: 0372-7629
IZUTSU, KENICHI: "An Introduction to Freeze-Drying of Protein Pharmaceuticals", JOURNAL OF PHARMACEUTICAL SCIENCE AND TECHNOLOGY, vol. 72, no. 6, 2012, Japan, pages 353 - 358, XP055585661, ISSN: 0372-7629
LIU, H. ET AL.: "Heterogeneity of monoclonal antibodies", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 97, no. 7, July 2008 (2008-07-01), pages 2426 - 2447, XP002530921, ISSN: 0022-3549, DOI: doi:10.1002/JPS.21180
MAITY, H. ET AL.: "Effects of arginine on photostability and thermal stability of lgG1 monoclonal antibodies", CURRENT PHARMACEUTICAL BIOTECHNOLOGY, vol. 10, no. 8, 2009, pages 761 - 766, XP009148288, ISSN: 1389-2010
Attorney, Agent or Firm:
YAMAGUCHI Kenjiro et al. (JP)
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