专利名称 | Recombinant formulations containing acidic α - glucosidase | ||
申请号 | JP2018551370 | 申请日 | |
公开(公告)号 | JP2019510068A | 公开(公告)日 | |
申请(专利权)人 | アミカス セラピューティックス インコーポレイテッド | 发明人 | チャー ヒング; テスラー セルゲイ; サンダーランド ウェンディ; ディローン エンリケ; ドー フン; ゴッシャル ラッセル |
专利来源 | 国家知识产权局 | 转化方式 | |
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. |
主管部门:海南中小企业服务 | 建设单位:海南商业联合会
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