公开(公告)号：US10087214B2

公开(公告)日：2018-10-02

申请号：US14598450

申请日：2015-01-16

Applicant: Genzyme Corporation

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

IPC: A61L2/08 ,  B01D15/18 ,  B01D15/20 ,  B01D15/36 ,  B01D15/38 ,  B01D15/42 ,  C07K1/16 ,  C07K1/22 ,  C12N9/40

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

公开(公告)号：US11369703B2

公开(公告)日：2022-06-28

申请号：US16543247

申请日：2019-08-16

Applicant: Genzyme Corporation

Inventor： Rohan Patil ,  Chad Varner

IPC: A61L2/08 ,  B01J20/26 ,  B01J20/28 ,  B01J20/286 ,  B01J20/30 ,  B01J41/04 ,  B01J49/60 ,  B01J47/02 ,  B01J47/014 ,  C07K1/18 ,  B01D15/36 ,  B01D15/38 ,  B01J41/12

Abstract: Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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：US20150203529A1

公开(公告)日：2015-07-23

申请号：US14598450

申请日：2015-01-16

Applicant: Genzyme Corporation

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

IPC: C07K1/16

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

Abstract translation: 本文提供了使用γ-辐射色谱树脂进行色谱法的方法，其包括提供包含γ-辐射色谱树脂的色谱柱; 通过色谱柱进行第一次色谱循环，其中循环包括将色谱树脂暴露于变性缓冲液; 并通过柱进行至少一个附加的色谱循环。 还提供了整合的，封闭的或基本上封闭的，连续的制备重组蛋白质的方法，其包括使用至少一个色谱柱，包括γ-照射的色谱树脂，其中在每个过程中将γ-辐照色谱树脂暴露于变性缓冲液 在该过程中循环，并且在该过程中使用减少的生物负载缓冲液。

公开(公告)号：US20210268477A1

公开(公告)日：2021-09-02

申请号：US17149613

申请日：2021-01-14

Applicant: Genzyme Corporation

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

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

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：US20180369786A1

公开(公告)日：2018-12-27

申请号：US16107110

申请日：2018-08-21

Applicant: Genzyme Corporation

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

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

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：US10071364B2

公开(公告)日：2018-09-11

申请号：US14598401

申请日：2015-01-16

Applicant: Genzyme Corporation

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

IPC: A61L2/08 ,  B01J20/34 ,  B01D15/36 ,  B01D15/38 ,  B01J20/26 ,  B01J20/281 ,  B01J41/12 ,  B01J41/20 ,  C07K1/16 ,  C07K1/22 ,  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：US20150203532A1

公开(公告)日：2015-07-23

申请号：US14629356

申请日：2015-02-23

Applicant: Genzyme Corporation

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

IPC: C07K1/22 ,  C12N9/40 ,  B01D15/42 ,  B01D15/36 ,  B01D15/38

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

公开(公告)号：US20150203531A1

公开(公告)日：2015-07-23

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: C07K1/22 ,  C07K1/18 ,  A61L2/08 ,  C07K1/16

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：US20200069822A1

公开(公告)日：2020-03-05

申请号：US16543247

申请日：2019-08-16

Applicant: Genzyme Corporation

Inventor： Rohan Patil ,  Chad Varner

IPC: A61L2/08 ,  B01J20/26 ,  B01J20/28 ,  B01J20/286 ,  B01J20/30 ,  B01J41/04 ,  B01J41/12 ,  B01J49/60 ,  B01J47/02 ,  B01J47/014 ,  C07K1/18 ,  B01D15/36 ,  B01D15/38

Abstract: Provided herein are methods of reducing bioburden of a chromatography resin that include exposing a container including a composition including (i) a chromatography resin and (ii) a liquid including at least on alcohol to a dose of gamma-irradiation sufficient to reduce the bioburden of the container and the chromatography resin, where the at least one alcohol 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 a liquid including at least one alcohol, 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：US20180354986A1

公开(公告)日：2018-12-13

申请号：US16107203

申请日：2018-08-21

Applicant: Genzyme Corporation

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

IPC: C07K1/16 ,  B01D15/38 ,  B01D15/18 ,  C12N9/40 ,  C07K1/22 ,  B01D15/42 ,  A61L2/08 ,  B01D15/36 ,  B01D15/20

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.