- 专利标题: FORMULATIONS COMPRISING RECOMBINANT ACID ALPHA-GLUCOSIDASE
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申请号: EP22165645.7申请日: 2017-03-30
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公开(公告)号: EP4098274A1公开(公告)日: 2022-12-07
- 发明人: CHAR, Hing , TESLER, Sergey , SUNDERLAND, Wendy , DILONE, Enrique , DO, Hung , GOTSCHALL, Russell
- 申请人: Amicus Therapeutics, Inc.
- 申请人地址: US Philadelphia, PA 19104 3675 Market Street
- 代理机构: Miller Sturt Kenyon
- 优先权: US201762457588 P 20170210
- 主分类号: A61K38/47
- IPC分类号: A61K38/47 ; C12N9/26 ; A61P3/00
摘要:
Provided are pharmaceutical formulations comprising a recombinant acid α-glucosidase, wherein the recombinant acid α-glucosidase is expressed in Chinese hamster ovary (CHO) cells and comprises an increased content of N-glycan units bearing one or two mannose-6-phosphate residues when compared to a content of N-glycan units bearing one or two mannose-6-phosphate residues of alglucosidase alfa; at least one buffer selected from the group consisting of a citrate, a phosphate and combinations thereof; and at least one excipient selected from the group consisting of mannitol, polysorbate 80, and combinations thereof, wherein the formulation has a pH of from about 5.0 to about 7.0. Also provided are methods of treating Pompe disease using these pharmaceutical formulations.
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