公开(公告)号：US20230242897A1

公开(公告)日：2023-08-03

申请号：US18298742

申请日：2023-04-11

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Meinhard Hasslacher ,  Christian Fiedler ,  Christa Mayer ,  Artur Mitterer

IPC: C12N9/64 ,  C12N11/14 ,  C12M1/00

CPC classification number: C12N9/6489 ,  C12Y304/24087 ,  C12N11/14 ,  C12M47/12

Abstract: Provided herein are methods for purifying recombinant A Disintegrin-like and Metallopeptidase with Thrombospondin Type 1 Motif 13 (ADAMTS13) protein from a sample. The method comprises enriching for ADAMTS13 protein by chromatographically contacting the sample with hydroxyapatite under conditions that allow ADAMTS13 protein to appear in the eluate or supernatant from the hydroxylapatite. The methods may further comprise tandem chromatography with a mixed mode cation exchange/hydrophobic interaction resin that binds ADAMTS13 protein. Additional optional steps involve ultrafiltration/diafiltration, anion exchange chromatography, cation exchange chromatography, and viral inactivation. Also provided herein are methods for inactivating virus contaminants in protein samples, where the protein is immobilized on a support. Also provided herein are compositions of ADAMTS13 prepared according to said methods.

公开(公告)号：US11000561B2

公开(公告)日：2021-05-11

申请号：US16347082

申请日：2017-11-03

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

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

IPC: C12N7/02 ,  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：US12246047B2

公开(公告)日：2025-03-11

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: C12N7/02 ,  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：US11981934B2

公开(公告)日：2024-05-14

申请号：US16958974

申请日：2018-12-27

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Christian Fiedler ,  Meinhard Hasslacher ,  Jadranka Koehn

IPC: C07K14/435 ,  A61K38/00 ,  B01D15/16 ,  B01D15/36 ,  B01D15/38 ,  B01D15/42 ,  C07K14/705 ,  C07K16/28 ,  C12N7/00 ,  G01N33/569

CPC classification number: C12N7/00 ,  B01D15/166 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  G01N33/56983 ,  C12N2750/14151 ,  G01N2333/075

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, and AAV is eluted from the affinity resin. Various buffers are disclosed for use in the wash steps and elution.

公开(公告)号：US11661593B2

公开(公告)日：2023-05-30

申请号：US14571670

申请日：2014-12-16

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Meinhard Hasslacher ,  Christian Fiedler ,  Christa Mayer ,  Artur Mitterer

IPC: C12N9/64 ,  C12N11/14 ,  C12M1/00

CPC classification number: C12N9/6489 ,  C12M47/12 ,  C12N11/14 ,  C12Y304/24087

Abstract: Provided herein are methods for purifying recombinant A Disintegrin-like and Metallopeptidase with Thrombospondin Type 1 Motif 13 (ADAMTS13) protein from a sample. The method comprises enriching for ADAMTS13 protein by chromatographically contacting the sample with hydroxyapatite under conditions that allow ADAMTS13 protein to appear in the eluate or supernatant from the hydroxylapatite. The methods may further comprise tandem chromatography with a mixed mode cation exchange/hydrophobic interaction resin that binds ADAMTS13 protein. Additional optional steps involve ultrafiltration/diafiltration, anion exchange chromatography, cation exchange chromatography, and viral inactivation. Also provided herein are methods for inactivating virus contaminants in protein samples, where the protein is immobilized on a support. Also provided herein are compositions of ADAMTS13 prepared according to said methods.

公开(公告)号：US11583563B2

公开(公告)日：2023-02-21

申请号：US16347107

申请日：2017-11-03

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

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：US12257277B2

公开(公告)日：2025-03-25

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 ,  A61K9/00 ,  A61K9/19 ,  A61K31/195 ,  A61K47/18 ,  A61K47/26 ,  A61P7/00 ,  A61P7/04

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：US20250002868A1

公开(公告)日：2025-01-02

申请号：US18294941

申请日：2022-08-03

Applicant: TAKEDA PHARMACEUTICAL COMPANY LIMITED

Inventor： Christian Fiedler ,  Dominik MITERGRADNEGGER ,  Meinhard HASSLACHER ,  Thomas GATTERNIG ,  Daniela VASINA ,  Michael FELDHOFER ,  Renate PFANDL

IPC: C12N7/00

Abstract: The present disclosure provides for a method of purifying adeno-associated virus comprising purifying full AAV capsids from a concentrated AAV fraction or preparation comprising empty AAV capsids and full AAV capsids. The present disclosure also provides for a method of purifying adeno-associated virus comprising purifying empty AAV capsids from a concentrated AAV fraction or preparation comprising empty AAV capsids and full AAV capsids. The method utilizes one or more monovalent and one or more divalent cations to effect the separation resulting in purified full AAV capsids or empty AAV capsids.