公开(公告)号：US20190339254A1

公开(公告)日：2019-11-07

申请号：US16395431

申请日：2019-04-26

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan MAO ,  Annamarie CRUZ ,  Bernhard SCHILLING ,  Scott CARVER

IPC: G01N33/50 ,  G01N33/58 ,  C12M1/12

Abstract: Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.

公开(公告)号：US20220404335A1

公开(公告)日：2022-12-22

申请号：US17804222

申请日：2022-05-26

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan MAO ,  Annamarie CRUZ ,  Bernhard SCHILLING ,  Scott CARVER

IPC: G01N33/50 ,  C12M1/12 ,  G01N33/58

Abstract: Embodiments of the present disclosure include methods and systems for detecting the presence of endotoxins in filters. For example, embodiments of the present disclosure are directed to methods and systems for improving in-process controls by detecting undesirable quantities of endotoxins in filters containing naturally-sourced materials prior to using those filters in the production of formulated drug substances.

公开(公告)号：US20190248850A1

公开(公告)日：2019-08-15

申请号：US16275467

申请日：2019-02-14

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan L. MAO ,  Scott CARVER ,  Bernhard SCHILLING ,  Eric SHIERLY

IPC: C07K14/475 ,  G01N30/86 ,  G01N30/56 ,  G01N30/74 ,  B01D15/36 ,  B01D15/32 ,  B01D15/20 ,  B01D15/42 ,  B01D15/38 ,  C07K1/16

CPC classification number: C07K14/475 ,  B01D15/206 ,  B01D15/327 ,  B01D15/363 ,  B01D15/3804 ,  B01D15/424 ,  C07K1/16 ,  G01N30/56 ,  G01N30/74 ,  G01N30/8651 ,  G01N30/8675 ,  G01N30/88 ,  G01N2030/027 ,  G01N2030/562 ,  G01N2030/889

Abstract: The disclosure provides systems and methods useful for predicting or detecting a malfunction in a chromatography process in real-time. In some embodiments, the disclosure provides systems and methods for detecting an atypical profile in a process chromatogram in ion-exchange chromatography of a biologic product.

公开(公告)号：US20220331468A1

公开(公告)日：2022-10-20

申请号：US17848936

申请日：2022-06-24

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan L. MAO ,  Wenbin QI ,  Bernhard SCHILLING ,  Scott CARVER

IPC: A61L2/18 ,  B01D15/38 ,  G01N30/50 ,  B01D15/20 ,  A61L2/28

Abstract: The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.

公开(公告)号：US20210388408A1

公开(公告)日：2021-12-16

申请号：US17409193

申请日：2021-08-23

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： John CHEN ,  Shawn LAWRENCE ,  Amy JOHNSON ,  Theodore LONEY ,  Ravindra PANGULE ,  Ta-Chun HANG ,  Scott CARVER ,  Bernhard SCHILLING

IPC: C12P21/00 ,  C07K14/47 ,  C07K14/715 ,  C07K14/71

Abstract: The instant application provides a method for screening batches of soy hydrolysate for a desired amount of a component thereof, such as ornithine or putrescine, and selecting only those batches of soy hydrolysate that have a desired amount of such component. The present disclosure also sets forth methods for culturing cells in media supplemented with selected batches of soy to produce more consistent, high quality lots of a protein of interest. Further, the present disclosure provides a plurality of protein preparations that have each been produced by culturing cells in media supplemented with separate batches of soy hydrolysate containing a desired amount of ornithine or putrescine, whereby each batch of protein produced exhibits improved quality of the protein of interest or amount of quality protein produced.

公开(公告)号：US20230273163A1

公开(公告)日：2023-08-31

申请号：US18313745

申请日：2023-05-08

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan L. MAO ,  Eric SHIERLY ,  Bernhard SCHILLING ,  Scott CARVER ,  Stefanie MCDERMOTT ,  John MATTILA ,  Hanne BAK

IPC: G01N30/88 ,  G01N30/86

CPC classification number: G01N30/88 ,  G01N30/8617 ,  G01N30/8693 ,  G01N2030/889

Abstract: Embodiments of the present disclosure are directed to methods and systems for assessing integrity of chromatography columns, systems, and processes. The methods and systems can comprise one or more of extracting a block and signal combination for analysis, performing a transition analysis, performing one or more statistical process controls, and/or implementing in-process controls based on the statistical process controls.

公开(公告)号：US20230020627A1

公开(公告)日：2023-01-19

申请号：US17953818

申请日：2022-09-27

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan L. MAO ,  Scott CARVER ,  Bernhard SCHILLING ,  Eric SHIERLY

IPC: G01N30/88 ,  G01N30/86 ,  G01N30/74 ,  B01D15/42 ,  B01D15/38 ,  C07K1/16

Abstract: The disclosure provides systems and methods useful for predicting or detecting a malfunction in a chromatography process in real-time. In some embodiments, the disclosure provides systems and methods for detecting an atypical profile in a process chromatogram in ion-exchange chromatography of a biologic product.

公开(公告)号：US20210388407A1

公开(公告)日：2021-12-16

申请号：US17409158

申请日：2021-08-23

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： John CHEN ,  Shawn LAWRENCE ,  Amy JOHNSON ,  Theodore LONEY ,  Ravindra PANGULE ,  Ta-Chun HANG ,  Scott CARVER ,  Bernhard SCHILLING

IPC: C12P21/00 ,  C07K14/47 ,  C07K14/715 ,  C07K14/71

Abstract: The instant application provides a method for screening batches of soy hydrolysate for a desired amount of a component thereof, such as ornithine or putrescine, and selecting only those batches of soy hydrolysate that have a desired amount of such component. The present disclosure also sets forth methods for culturing cells in media supplemented with selected batches of soy to produce more consistent, high quality lots of a protein of interest. Further, the present disclosure provides a plurality of protein preparations that have each been produced by culturing cells in media supplemented with separate batches of soy hydrolysate containing a desired amount of ornithine or putrescine, whereby each batch of protein produced exhibits improved quality of the protein of interest or amount of quality protein produced.

公开(公告)号：US20210138098A1

公开(公告)日：2021-05-13

申请号：US17153205

申请日：2021-01-20

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan L. MAO ,  Wenbin QI ,  Bernhard SCHILLING ,  Scott CARVER

IPC: A61L2/18 ,  B01D15/38 ,  G01N30/50 ,  B01D15/20 ,  A61L2/28

Abstract: The invention provides methods for microbial bioburden reduction of various chromatography matrices, including bioburden reduction in the context of large-scale Protein A-based affinity chromatography columns.

公开(公告)号：US20240345048A1

公开(公告)日：2024-10-17

申请号：US18673492

申请日：2024-05-24

Applicant: Regeneron Pharmaceuticals, Inc.

Inventor： Nathan L. MAO ,  Scott CARVER ,  Bernhard SCHILLING ,  Eric SHIERLY

IPC: G01N30/88 ,  B01D15/20 ,  B01D15/32 ,  B01D15/36 ,  B01D15/38 ,  B01D15/42 ,  C07K1/16 ,  C07K14/475 ,  G01N30/02 ,  G01N30/56 ,  G01N30/74 ,  G01N30/86

CPC classification number: G01N30/88 ,  B01D15/3804 ,  B01D15/424 ,  C07K1/16 ,  G01N30/74 ,  G01N30/8651 ,  G01N30/8675 ,  B01D15/206 ,  B01D15/327 ,  B01D15/363 ,  C07K14/475 ,  G01N2030/027 ,  G01N30/56 ,  G01N2030/562 ,  G01N2030/889

Abstract: The disclosure provides systems and methods useful for predicting or detecting a malfunction in a chromatography process in real-time. In some embodiments, the disclosure provides systems and methods for detecting an atypical profile in a process chromatogram in ion-exchange chromatography of a biologic product.