Invention Grant
- Patent Title: Lyophilized preparation
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Application No.: US16474307Application Date: 2017-12-28
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Publication No.: US10940185B2Publication Date: 2021-03-09
- Inventor: Hidehito Yasukawa , Yuka Yamaguchi , Shinji Okabe
- Applicant: JCR Pharmaceuticals Co., Ltd.
- Applicant Address: JP Hyogo
- Assignee: JCR Pharmaceuticals Co., Ltd.
- Current Assignee: JCR Pharmaceuticals Co., Ltd.
- Current Assignee Address: JP Hyogo
- Agency: Morgan, Lewis & Bockius LLP
- Priority: JPJP2016-257060 20161228
- International Application: PCT/JP2017/047207 WO 20171228
- International Announcement: WO2018/124277 WO 20180705
- Main IPC: C12N9/16
- IPC: C12N9/16 ; A61K38/46 ; A61K9/19 ; A61K47/02 ; A61K47/10 ; A61K47/26 ; A61K47/34 ; C07K16/28

Abstract:
[Problem] To provide a pharmaceutical composition containing a fusion protein comprising an antibody and a lysosomal enzyme as an active ingredient, which is stable enough to permit its distribution to the market.
[Solution] A lyophilized formulation containing; a fusion protein comprising an antibody and a lysosomal enzyme as an active ingredient, and further containing a neutral salt, a disaccharide, a nonionic surfactant, and a buffer. Such a lyophilized formulation includes, for example, as an active ingredient, a fusion protein comprising an anti-transferrin receptor antibody and human iduronate-2-sulfatase, and further containing sodium chloride as the neutral salt, sucrose as the disaccharide, poloxamer as the nonionic surfactant, and phosphate buffer as the buffer.
[Solution] A lyophilized formulation containing; a fusion protein comprising an antibody and a lysosomal enzyme as an active ingredient, and further containing a neutral salt, a disaccharide, a nonionic surfactant, and a buffer. Such a lyophilized formulation includes, for example, as an active ingredient, a fusion protein comprising an anti-transferrin receptor antibody and human iduronate-2-sulfatase, and further containing sodium chloride as the neutral salt, sucrose as the disaccharide, poloxamer as the nonionic surfactant, and phosphate buffer as the buffer.
Public/Granted literature
- US20190336586A1 Lyophilized Preparation Public/Granted day:2019-11-07
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