公开(公告)号：EP4360652A2

公开(公告)日：2024-05-01

申请号：EP24160547.6

申请日：2017-11-03

申请人： Takeda Pharmaceutical Company Limited

发明人： FIEDLER, Christian ,  FRITSCHER, Eva ,  HASSLACHER, Meinhard ,  MITTERGRADNEGGER, Dominik ,  TABISH, Tanvir

IPC分类号： A61K47/26

CPC分类号： A61K31/195 ,  A61K35/76 ,  A61P7/00 ,  A61K9/0019 ,  A61K9/19 ,  A61K47/183 ,  A61K47/22 ,  A61K47/26 ,  A61K47/02 ,  A61K47/18 ,  C12N15/86

摘要： Adeno-associated liquid and lyophilized pharmaceutical compositions are provided herein. In exemplary aspects, the pharmaceutical compositions comprise about 5 mM to about 25 mM L-histidine, about 0 mM to about 150 mM sodium chloride, about 0.001 % (w/v) to about 0.01 % (w/v) polysorbate 80 (PS80), and about 1 % to about 10% (w/v) sucrose, trehalose, or combination thereof to AAV. In exemplary aspects, the pharmaceutical compositions further comprise glycine or mannitol. Methods of preparing a pharmaceutical composition comprising AAV, methods of treating a bleeding disorder in a subject, and methods of storing AAV compositions are also provided.

公开(公告)号：EP4360652A3

公开(公告)日：2024-06-26

申请号：EP24160547.6

申请日：2017-11-03

申请人： Takeda Pharmaceutical Company Limited

发明人： FIEDLER, Christian ,  FRITSCHER, Eva ,  HASSLACHER, Meinhard ,  MITTERGRADNEGGER, Dominik ,  TABISH, Tanvir

IPC分类号： C12N15/86 ,  A61K35/76 ,  A61K31/195 ,  A61P7/00 ,  A61K9/00 ,  A61K9/19 ,  A61K47/02 ,  A61K47/18 ,  A61K47/22 ,  A61K47/26

CPC分类号： A61K31/195 ,  A61K35/76 ,  A61P7/00 ,  A61K9/0019 ,  A61K9/19 ,  A61K47/183 ,  A61K47/22 ,  A61K47/26 ,  A61K47/02 ,  A61K47/18 ,  C12N15/86

摘要： Adeno-associated liquid and lyophilized pharmaceutical compositions are provided herein. In exemplary aspects, the pharmaceutical compositions comprise about 5 mM to about 25 mM L-histidine, about 0 mM to about 150 mM sodium chloride, about 0.001 % (w/v) to about 0.01 % (w/v) polysorbate 80 (PS80), and about 1 % to about 10% (w/v) sucrose, trehalose, or combination thereof to AAV. In exemplary aspects, the pharmaceutical compositions further comprise glycine or mannitol. Methods of preparing a pharmaceutical composition comprising AAV, methods of treating a bleeding disorder in a subject, and methods of storing AAV compositions are also provided.

公开(公告)号：EP3990031A1

公开(公告)日：2022-05-04

申请号：EP20833341.9

申请日：2020-06-26

申请人： Takeda Pharmaceutical Company Limited

发明人： FIEDLER, Christian ,  SCHEINDEL, Marcus ,  HASSLACHER, Meinhard ,  KOEHN, Jadranka

IPC分类号： A61K48/00 ,  C12N7/00 ,  C12N7/02 ,  C12N15/09 ,  C12N15/864

公开(公告)号：EP4381053A1

公开(公告)日：2024-06-12

申请号：EP22777298.5

申请日：2022-08-03

申请人： Takeda Pharmaceutical Company Limited

发明人： FIEDLER, Christian ,  MITTERGRADNEGGER, Dominik ,  HASSLACHER, Meinhard ,  GATTERNIG, Thomas ,  VASINA, Daniela ,  FELDHOFER, Michael ,  PFANDL, Renate

IPC分类号： C12N7/00

CPC分类号： C12N2750/1415120130101 ,  C12N7/00 ,  C12N15/86