公开(公告)号：US20210338752A1

公开(公告)日：2021-11-04

申请号：US17227527

申请日：2021-04-12

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Christian FIEDLER ,  Leopold Grillberger ,  Meinhard Hasslacher ,  Barbara Kraus ,  Dominik Mittergradnegger ,  Stefan Reuberger ,  Horst Schafhauser ,  Marian Bendik

IPC: A61K35/761 ,  C12N7/00

Abstract: Provided herein are methods of producing an adeno-associated virus (AAV) product, methods of purifying adeno-associated virus, and methods of purifying full AAV capsids from a concentrated AAV fraction comprising empty AAV capsids and full AAV capsids.

公开(公告)号：US20230241139A1

公开(公告)日：2023-08-03

申请号：US18096853

申请日：2023-01-13

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

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

IPC: A61K35/76 ,  A61P7/04 ,  A61K9/00 ,  A61K9/19 ,  A61K47/18 ,  A61K47/26 ,  A61P7/00 ,  A61K31/195

CPC classification number: A61K35/76 ,  A61P7/04 ,  A61K9/0019 ,  A61K9/0053 ,  A61K9/19 ,  A61K47/183 ,  A61K47/26 ,  A61P7/00 ,  A61K31/195

Abstract: 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：US20220267796A1

公开(公告)日：2022-08-25

申请号：US17622044

申请日：2020-06-26

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Christian FIEDLER ,  Marcus SCHEINDEL ,  Meinhard HASSLACHER ,  Jadranka KOEHN

IPC: C12N15/86 ,  B01D15/16 ,  B01D15/38

Abstract: Provided herein are methods of producing an adeno-associated virus (AAV) product and methods of purifying adeno-associated virus. AAV is loaded onto an affinity resin, wash steps are undertaken at room temperature, and AAV is eluted from the affinity resin at a lower temperature. Various buffers are disclosed for use in the wash steps and elution.