Title:
METHOD FOR PREPARING ANTIBODY-CONTAINING FORMULATION
Document Type and Number:
WIPO Patent Application WO/2023/100975
Kind Code:
A1
Abstract:
The present invention provides a pharmaceutical formulation that reduces formation of particles including an anti-IL-6 receptor antibody that inhibits binding with a receptor for interleukin 6 or an anti-blood coagulation factor IXa/X antibody (bispecific monoclonal antibody) used as a substitution for coagulation factor VIII. The provided pharmaceutical formulation includes an aqueous solution containing a polyoxyethylene polyoxypropylene glycol (poloxamer). The poloxamer is represented by formula I: HO(C2H4O)a(C3H6O)b(C2H4O)cH [in the formula, a and c each independently represent an integer selected from 75-85, b represents an integer selected from 22-33, and a, b, and c are each an average with respect to the whole of the poloxamer]. The poloxamer contains a poloxamer molecule including 34 or more of (C3H6O) within the molecule, at a proportion of 3%(w/w) or more with respect to the whole poloxamer.
Inventors:
SOEDA KOHEI (JP)
FUKUDA MASAKAZU (JP)
TAKAHASHI MASAYA (JP)
IMAI HIROTAKA (JP)
SAITOH SATOSHI (JP)
DUBOEUF JEREMY (CH)
RAVURI KISHORE (CH)
KOPF ROBERT (CH)
CHEN WEI (CH)
OLTRA NURIA SANCHO (CH)
FUKUDA MASAKAZU (JP)
TAKAHASHI MASAYA (JP)
IMAI HIROTAKA (JP)
SAITOH SATOSHI (JP)
DUBOEUF JEREMY (CH)
RAVURI KISHORE (CH)
KOPF ROBERT (CH)
CHEN WEI (CH)
OLTRA NURIA SANCHO (CH)
Application Number:
PCT/JP2022/044355
Publication Date:
June 08, 2023
Filing Date:
December 01, 2022
Export Citation:
Assignee:
CHUGAI PHARMACEUTICAL CO LTD (JP)
HOFFMANN LA ROCHE (US)
HOFFMANN LA ROCHE (US)
HOFFMANN LA ROCHE (US)
HOFFMANN LA ROCHE (US)
International Classes:
A61K39/395; A61K9/08; A61K47/10; A61K47/26; A61P7/04; A61P29/00
Domestic Patent References:
| WO2017188356A1 | 2017-11-02 | |||
| WO2021241720A1 | 2021-12-02 | |||
| WO2004075913A1 | 2004-09-10 |
Foreign References:
| JP2010215664A | 2010-09-30 |
Other References:
FDA: "HEMLIBRA ® (emicizumab-kxwh) injection, for subcutaneous use Initial U.S. Approval: 2017", HIGHLIGHTS OF PRESCRIBING INFORMATION, 1 November 2017 (2017-11-01), pages 1 - 16, XP093070084, Retrieved from the Internet [retrieved on 20230803]
ANONYMOUS: "ENSPRYNG Subcutaneous Injection 120mg Syringe Deliberation Results Report", PDMA RESULTS REPORT, XP009546869, Retrieved from the Internet
SOEDA KOHEI, FUKUDA MASAKAZU, TAKAHASHI MASAYA, IMAI HIROTAKA, ARAI KENGO, SAITOH SATOSHI, KISHORE RAVURI S.K., OLTRA NURIA, DUBOE: "Impact of Poloxamer 188 material attributes on proteinaceous visible particle formation in liquid monoclonal antibody formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 111, no. 8, 21 April 2022 (2022-04-21), US , pages 2191 - 2200, XP009546772, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2022.04.012
HAOFAN PENG; AMR ALI; MAUREEN LANAN; ERIK HUGHES; KELLY WILTBERGER; BING GUAN; SHASHI PRAJAPATI; WEIWEI HU: "Mechanism investigation for poloxamer 188 raw material variation in cell culture", BIOTECHNOLOGY PROGRESS, AMERICAN CHEMICAL SOCIETY, HOBOKEN, USA, vol. 32, no. 3, 27 April 2016 (2016-04-27), Hoboken, USA, pages 767 - 775, XP072291639, ISSN: 8756-7938, DOI: 10.1002/btpr.2268
ANONYMOUS: "ENSPRYNG Subcutaneous Injection 120mg Syringe Deliberation Results Report", PDMA RESULTS REPORT, XP009546869, Retrieved from the Internet
SOEDA KOHEI, FUKUDA MASAKAZU, TAKAHASHI MASAYA, IMAI HIROTAKA, ARAI KENGO, SAITOH SATOSHI, KISHORE RAVURI S.K., OLTRA NURIA, DUBOE: "Impact of Poloxamer 188 material attributes on proteinaceous visible particle formation in liquid monoclonal antibody formulations", JOURNAL OF PHARMACEUTICAL SCIENCES, AMERICAN CHEMICAL SOCIETY AND AMERICAN PHARMACEUTICAL ASSOCIATION, US, vol. 111, no. 8, 21 April 2022 (2022-04-21), US , pages 2191 - 2200, XP009546772, ISSN: 0022-3549, DOI: 10.1016/j.xphs.2022.04.012
HAOFAN PENG; AMR ALI; MAUREEN LANAN; ERIK HUGHES; KELLY WILTBERGER; BING GUAN; SHASHI PRAJAPATI; WEIWEI HU: "Mechanism investigation for poloxamer 188 raw material variation in cell culture", BIOTECHNOLOGY PROGRESS, AMERICAN CHEMICAL SOCIETY, HOBOKEN, USA, vol. 32, no. 3, 27 April 2016 (2016-04-27), Hoboken, USA, pages 767 - 775, XP072291639, ISSN: 8756-7938, DOI: 10.1002/btpr.2268
Attorney, Agent or Firm:
YAMAMOTO, Osamu et al. (JP)
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