Title:
HUMAN ANTI-IL-33 MONOCLONAL-ANTIBODY-CONTAINING PHARMACEUTICAL COMPOSITION
Document Type and Number:
WIPO Patent Application WO/2020/054871
Kind Code:
A1
Abstract:
The purpose of the present invention is to provide a pharmaceutical composition containing a human anti-IL-33 monoclonal antibody suitable for administration to a subject. The present invention provides a pharmaceutical composition containing a human anti-IL-33 monoclonal antibody as an active ingredient, wherein the pharmaceutical composition is substantially free of sodium chloride or contains less than 30 mM of sodium chloride. The present invention also provides a freeze-dried form of the pharmaceutical composition.
Inventors:
IKEMOTO KEISUKE (JP)
MORI NAOKI (JP)
SAITO HIROSHI (JP)
TANIMOTO MASAHIRO (JP)
MORI NAOKI (JP)
SAITO HIROSHI (JP)
TANIMOTO MASAHIRO (JP)
Application Number:
PCT/JP2019/036239
Publication Date:
March 19, 2020
Filing Date:
September 13, 2019
Export Citation:
Assignee:
MITSUBISHI TANABE PHARMA CORP (JP)
International Classes:
A61K39/395; A61K9/08; A61K9/19; A61K47/02; A61K47/10; A61K47/12; A61K47/18; A61K47/26; A61P11/06; A61P15/00; A61P17/00; A61P37/08
Domestic Patent References:
| WO2015099175A1 | 2015-07-02 | |||
| WO2015099175A1 | 2015-07-02 |
Foreign References:
| JP2017008003A | 2017-01-12 | |||
| US4816567A | 1989-03-28 |
Other References:
UCHIYAMA, SUSUMU: "Analytical tips for Biopharmaceutics: foundation and application for quality assessment. Part 6. Property of protein solution", PHARM TECH JAPAN , vol. 34, no. 1, January 2018 (2018-01-01), pages 109 - 120, XP009526786, ISSN: 0910-4739
HONDA, SHINYA; MIYAFUSA, TAKAMITSU; IMAMURA, HIROSHI; WATANAE, HIDEKI; OOISHI, AYAKO: "Analytical tips for biopharmaceutics: foundation and application for quality assessment. Part 9: Analyzing and engineering protein stabilities", PHARM TECH JAPAN , vol. 34, no. 5, April 2018 (2018-04-01), pages 107 (885) - 116 (894), XP009526785, ISSN: 0910-4739
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
KOHLE ET AL., NATURE, vol. 256, 1975, pages 495
CLACKSON ET AL., NATURE, vol. 352, 1991, pages 624 - 628
MARKS ET AL., J. MOL. BIOL., vol. 222, 1991, pages 581 - 597
KABAT ET AL.: "Sequences of Proteins of Immunological Interest", 1991, PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH, pages: 247 - 301
JONES, A.: "Adv. Drug Delivery Rev.", vol. 10, 1993, pages: 29 - 90
REYMAY, FREEZE-DRYING/LYOPHILIZATION OF PHARMACEUTICAL & BIOLOGICAL PRODUCTS, 2004, ISBN: ISBN 0824748689
See also references of EP 3851121A4
HONDA, SHINYA; MIYAFUSA, TAKAMITSU; IMAMURA, HIROSHI; WATANAE, HIDEKI; OOISHI, AYAKO: "Analytical tips for biopharmaceutics: foundation and application for quality assessment. Part 9: Analyzing and engineering protein stabilities", PHARM TECH JAPAN , vol. 34, no. 5, April 2018 (2018-04-01), pages 107 (885) - 116 (894), XP009526785, ISSN: 0910-4739
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
KOHLE ET AL., NATURE, vol. 256, 1975, pages 495
CLACKSON ET AL., NATURE, vol. 352, 1991, pages 624 - 628
MARKS ET AL., J. MOL. BIOL., vol. 222, 1991, pages 581 - 597
KABAT ET AL.: "Sequences of Proteins of Immunological Interest", 1991, PUBLIC HEALTH SERVICE, NATIONAL INSTITUTES OF HEALTH, pages: 247 - 301
JONES, A.: "Adv. Drug Delivery Rev.", vol. 10, 1993, pages: 29 - 90
REYMAY, FREEZE-DRYING/LYOPHILIZATION OF PHARMACEUTICAL & BIOLOGICAL PRODUCTS, 2004, ISBN: ISBN 0824748689
See also references of EP 3851121A4
Attorney, Agent or Firm:
AOKI, Atsushi et al. (JP)
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