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公开(公告)号：US11491211B2
公开(公告)日：2022-11-08
申请号：US16654521
申请日：2019-10-16
发明人： Hing Char , Sergey Tesler , Wendy Sunderland , Enrique Diloné , Russell Gotschall , Hung Do
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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公开(公告)号：US20200171133A1
公开(公告)日：2020-06-04
申请号：US16654521
申请日：2019-10-16
发明人： Hing Char , Sergey Tesler , Wendy Sunderland , Enrique Diloné , Russell Gotschall , Hung Do
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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公开(公告)号：US20240066104A1
公开(公告)日：2024-02-29
申请号：US18053151
申请日：2022-11-07
发明人： Hing Char , Sergey Tesler , Wendy Sunderland , Enrique Diloné , Russell Gotschall , Hung V. Do
CPC分类号： A61K38/47 , A61K9/0095 , A61K9/19 , A61K47/02 , A61K47/12 , A61K47/26 , C12N9/2408 , C12Y302/0102
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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公开(公告)号：US20210393747A1
公开(公告)日：2021-12-23
申请号：US16613919
申请日：2018-05-15
发明人： Hung DO , Russell Gotschall , Richie Khanna , Yi Lun , Hing Char , Sergey Tesler , Wendy Sunderland , Enrique Diloné
摘要： Provided are a recombinant acid α-glucosidase and pharmaceutical composition 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. Also provided herein are methods of producing, purifying, and formulating the recombinant acid α-glucosidase or pharmaceutical composition for administration to a subject and methods of treating a disease or disorder such as Pompe disease using the recombinant acid α-glucosidase or pharmaceutical composition.
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公开(公告)号：US10512676B2
公开(公告)日：2019-12-24
申请号：US15473999
申请日：2017-03-30
发明人： Hing Char , Sergey Tesler , Wendy Sunderland , Enrique Diloné , Russell Gotschall , Hung Do
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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公开(公告)号：US20170333534A1
公开(公告)日：2017-11-23
申请号：US15473999
申请日：2017-03-30
发明人： Hing Char , Sergey Tesler , Wendy Sunderland , Enrique Diloné
CPC分类号： A61K38/47 , A61K9/0095 , A61K9/19 , A61K47/02 , A61K47/12 , A61K47/26 , C12N9/2408 , C12Y302/0102
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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