公开(公告)号：US09657056B2

公开(公告)日：2017-05-23

申请号：US14645138

申请日：2015-03-11

Applicant: Genzyme Corporation

Inventor： Konstantin Konstantinov ,  Rahul Godawat ,  Veena Warikoo ,  Sujit Jain

IPC: C07K1/22 ,  C07K16/00 ,  C12P21/00 ,  C12N9/00 ,  C07K1/36 ,  B01D15/18 ,  B01D15/32 ,  B01D15/36 ,  C07K1/16 ,  C07K1/18 ,  C12N9/24 ,  C12N9/36 ,  B01D15/38 ,  C12N9/40 ,  C12M1/00

CPC classification number: C07K1/16 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/1871 ,  B01D15/327 ,  B01D15/34 ,  B01D15/362 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/3814 ,  B01D15/422 ,  C07K1/18 ,  C07K1/22 ,  C07K1/36 ,  C07K16/00 ,  C07K2317/14 ,  C12M23/52 ,  C12M47/10 ,  C12M47/12 ,  C12N9/00 ,  C12N9/2402 ,  C12N9/2465 ,  C12P21/00 ,  C12P21/005 ,  C12Y302/01022 ,  C12Y302/01045

Abstract: Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.

公开(公告)号：US09650412B2

公开(公告)日：2017-05-16

申请号：US14195481

申请日：2014-03-03

Applicant: Genzyme Corporation

Inventor： Konstantin Konstantinov ,  Rahul Godawat ,  Veena Warikoo ,  Sujit Jain

IPC: C07K1/22 ,  C07K16/00 ,  C12P21/00 ,  C12N9/00 ,  C07K1/36 ,  B01D15/18 ,  B01D15/32 ,  B01D15/36 ,  B01D15/38 ,  C07K1/16 ,  C07K1/18 ,  C12N9/24 ,  C12N9/40 ,  C12M1/00

CPC classification number: C07K1/16 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/1871 ,  B01D15/327 ,  B01D15/34 ,  B01D15/362 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/3814 ,  B01D15/422 ,  C07K1/18 ,  C07K1/22 ,  C07K1/36 ,  C07K16/00 ,  C07K2317/14 ,  C12M23/52 ,  C12M47/10 ,  C12M47/12 ,  C12N9/00 ,  C12N9/2402 ,  C12N9/2465 ,  C12P21/00 ,  C12P21/005 ,  C12Y302/01022 ,  C12Y302/01045

Abstract: Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.

公开(公告)号：US09630165B2

公开(公告)日：2017-04-25

申请号：US14629315

申请日：2015-02-23

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala

IPC: B01J20/34 ,  B01D15/36 ,  B01D15/38 ,  B01J20/26 ,  B01J20/281 ,  B01J41/12 ,  B01J41/20 ,  C07K1/16 ,  C07K1/22 ,  A61L2/08 ,  C07K1/18 ,  B01D15/18 ,  B01D15/20 ,  B01D15/32 ,  B01D15/34 ,  B01J39/26

CPC classification number: B01J20/3441 ,  A61L2/081 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/327 ,  B01D15/34 ,  B01D15/362 ,  B01D15/363 ,  B01D15/3804 ,  B01J20/265 ,  B01J20/281 ,  B01J39/26 ,  B01J41/12 ,  B01J41/20 ,  C07K1/16 ,  C07K1/18 ,  C07K1/22 ,  Y10T29/49826

Abstract: Provided herein are methods of reducing bioburden of (e.g., sterilizing) a chromatography resin that include exposing a container including a composition including a chromatography resin and at least one antioxidant agent and/or chelator to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one antioxidant agent and/or chelator are present in an amount sufficient to ameliorate the loss of binding capacity of the chromatography resin after/upon exposure to the dose of gamma-irradiation. Also provided are reduced bioburden chromatography columns including the reduced bioburden chromatography resin, compositions including a chromatography resin and at least one chelator and/or antioxidant agent, methods of performing reduced bioburden column chromatography using one of these reduced bioburden chromatography columns, and integrated, closed, and continuous processes for reduced bioburden manufacturing of a purified recombinant protein.

公开(公告)号：US20150183821A1

公开(公告)日：2015-07-02

申请号：US14645138

申请日：2015-03-11

Applicant: Genzyme Corporation

Inventor： Konstantin Konstantinov ,  Rahul Godawat ,  Veena Warikoo ,  Sujit Jain

IPC: C07K1/22 ,  C07K1/18 ,  C07K1/16 ,  B01D15/38 ,  C12N9/24 ,  B01D15/18 ,  B01D15/36 ,  B01D15/32 ,  C07K16/00 ,  C12N9/40

CPC classification number: C07K1/16 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/1871 ,  B01D15/327 ,  B01D15/34 ,  B01D15/362 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/3814 ,  B01D15/422 ,  C07K1/18 ,  C07K1/22 ,  C07K1/36 ,  C07K16/00 ,  C07K2317/14 ,  C12M23/52 ,  C12M47/10 ,  C12M47/12 ,  C12N9/00 ,  C12N9/2402 ,  C12N9/2465 ,  C12P21/00 ,  C12P21/005 ,  C12Y302/01022 ,  C12Y302/01045

Abstract: Provided herein are integrated continuous biomanufacturing processes for producing a therapeutic protein drug substance. Also provided are systems that are capable of continuously producing a therapeutic protein drug substance.