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1. 发明申请

US20190169559A1 CELL RETENTION DEVICE AND METHOD 审中-公开
公开(公告)号：US20190169559A1
公开(公告)日：2019-06-06
申请号：US16092482
申请日：2017-04-13
申请人： Boehringer Ingelheim International GmbH
发明人： Jonathan COFFMAN , Scott GODFREY , Samantha WANG
IPC分类号： C12M1/00
摘要： The subject technology relates to a cell retention device and method for use in a perfusion cell culture system where the cell retention device includes a hollow-fiber filter having an average pore size ranging from about 0.5 to about 20 μm and having the ability to operate under perfusion cell culture conditions for up to 35 days without being clogged or losing its product sieving ability by more than 20%.

2. 发明申请

US20210380923A1 METHOD FOR MEMBRANE GAS TRANSFER IN HIGH DENSITY BIOREACTOR CULTURE 有权
公开(公告)号：US20210380923A1
公开(公告)日：2021-12-09
申请号：US17283273
申请日：2019-10-08
申请人： Boehringer Ingelheim International GmbH
发明人： Jonathan COFFMAN , Scott GODFREY , Lisa SAWICKI
IPC分类号： C12M1/00 , C12M1/21 , C12M1/34 , C12M1/04
摘要： The present invention provides improved bioprocessing systems and methods for cell culture using the improved bioreactors, e.g., batch-fed or perfusion bioreactor cell culture systems for production of monoclonal or bi-specific antibodies, which are modified to include one or more membrane gas transfer modules in place of a sparger- or microsparger-based aeration systems to better regulate the levels of critical gases in a bioreactor cell culture, e.g., the dissolved levels of O2 and CO2, even at high cell densities, without subjecting the cells to bubble-burst associated cell death.

3. 发明申请

US20210380914A1 NOVEL CONTINUOUS FLOW REACTOR FOR LOW PH VIRAL INACTIVATION 有权
公开(公告)号：US20210380914A1
公开(公告)日：2021-12-09
申请号：US17283281
申请日：2019-10-07
申请人： Boehringer Ingelheim International GmbH
发明人： Stephanie PARKER , Cameron Lee BARDLIVING , Jonathan COFFMAN , Scott GODFREY , Raquel OROZCO
IPC分类号： C12M1/12 , C12M1/00 , C12N7/00
摘要： A viral inactivation device including at least one continuous viral inactivation reactor having an inlet, an outlet, and a tubular flow path. The tubular flow path includes a set of alternating turns that form a serpentine pattern between the inlet and the outlet.

4. 发明公开

US20240301363A1 METHODS FOR CONTINUOUSLY INACTIVATING A VIRUS DURING MANUFACTURE OF A PROTEIN 审中-公开
公开(公告)号：US20240301363A1
公开(公告)日：2024-09-12
申请号：US18662554
申请日：2024-05-13
申请人： Boehringer Ingelheim International GmbH
发明人： Marcus Andre FIADEIRO , Jonathan COFFMAN , Robert Lee FAHRNER , Jill Ann KUBLBECK , Raquel OROZCO , Jeffrey Richard SALM
IPC分类号： C12N7/00 , C07K16/00
CPC分类号： C12N7/00 , C07K16/00 , C07K2317/14
摘要： Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined conditions; and (4) subjecting the treatment composition to a post-treatment processing operation. The single predetermined volumetric ratio has been selected to ensure that the predetermined property of the treatment composition is maintained across a range of concentrations predicted for the protein in the composition including the protein. Steps (1) to (3) are carried out (a) continuously and (b) without feedback control being exerted by either adjustment of the volumetric ratio or diversion of the treatment composition.

5. 发明申请

US20220340948A1 CONCENTRATED PERFUSION MEDIUM 有权
公开(公告)号：US20220340948A1
公开(公告)日：2022-10-27
申请号：US17763723
申请日：2020-09-25
申请人： Boehringer Ingelheim International GmbH
发明人： Jonathan COFFMAN , Henry LIN , Todd LUMAN , Daisie OGAWA , Janani RAVIKRISHNAN , Hayden TESSMAN , Samet YILDIRIM , Marcella YU
IPC分类号： C12P21/00 , C12N15/62 , C12N5/071 , C12M1/00 , C12M1/34
摘要： The invention relates to a serum-free cell culture perfusion medium comprising the medium components subgrouped into at least three separate aqueous concentrated feeds and a diluent, wherein the resulting serum-free cell culture perfusion medium is pH-adjusting to neutral pH upon mixing. Also provided is a method of preparing said serum-free cell culture perfusion medium. The invention further relates to methods of culturing mammalian cells or producing a protein of interest in perfusion culture using said serum-free cell culture perfusion medium that achieve high productivity at a low cell specific perfusion rate. The invention further relates to the use of the new and improved serum-free cell culture perfusion medium to control osmolality in a perfusion cell culture, wherein increasing osmolality results in an increase in total productivity and/or cell specific productivity by suppressing cell growth during cell culture, e.g., during production phase of perfusion cell culture. Suppression of cell growth particularly reduces or eliminates the need for wasteful cell bleed.

6. 发明申请

US20190071647A1 METHODS FOR CONTINUOUSLY INACTIVATING A VIRUS DURING MANUFACTURE OF A PROTEIN 审中-公开
公开(公告)号：US20190071647A1
公开(公告)日：2019-03-07
申请号：US16083650
申请日：2017-03-10
申请人： Boehringer Ingelheim International GmbH
发明人： Marcus Andre FIADEIRO , Jonathan COFFMAN , Robert Lee FAHRNER , Jill Ann KUBLBECK , Raquel OROZCO , Jeffrey Richard SALM
IPC分类号： C12N7/00 , C07K16/00
摘要： Methods for continuously inactivating a virus during manufacture of a protein are provided. Steps include (1) combining, at a single predetermined volumetric ratio, a composition including the protein, and a composition including a virus-inactivation reagent, to obtain a treatment composition having a predetermined property for inactivation of a virus; (2) transferring the treatment composition to a treatment vessel; (3) incubating the treatment composition in the treatment vessel at predetermined conditions; and (4) subjecting the treatment composition to a post-treatment processing operation. The single predetermined volumetric ratio has been selected to ensure that the predetermined property of the treatment composition is maintained across a range of concentrations predicted for the protein in the composition including the protein. Steps (1) to (3) are carried out (a) continuously and (b) without feedback control being exerted by either adjustment of the volumetric ratio or diversion of the treatment composition.

7. 发明公开

US20230340425A1 METHODS, APPARATUSES, AND SYSTEMS FOR CONTINUOUSLY INACTIVATING A VIRUS DURING MANUFACTURE OF A BIOLOGICAL PRODUCT 审中-公开
公开(公告)号：US20230340425A1
公开(公告)日：2023-10-26
申请号：US18343861
申请日：2023-06-29
申请人： Boehringer Ingelheim International GmbH
发明人： Jonathan COFFMAN , Jeff GOBY , Scott GODFREY , Raquel OROZCO , Jens Holger VOGEL
IPC分类号： C12N7/00 , A61L2/00 , C07K1/14 , C07K1/16
CPC分类号： C12N7/00 , A61L2/0082 , C07K1/14 , C07K1/16 , C12N2710/00063 , A61L2202/21
摘要： Methods for continuously inactivating virus during manufacture of a biological product are provided. The methods include steps of (1) combining (a) a composition including a biological product, and (b) a composition including a virus-inactivation reagent, to obtain (c) a treatment composition having a predetermined property for inactivation of a virus, (2) confirming that the treatment composition exhibits the predetermined property, (3) transferring the treatment composition to a treatment vessel that includes an inlet, an outlet, and a static mixer, the transferring occurring at the inlet, (4) incubating the treatment composition in the treatment vessel at a predetermined temperature while the treatment composition flows at a predetermined rate and contacts the static mixer, and (5) collecting the treatment composition from the treatment vessel at the outlet, wherein steps (1) to (5) are carried out continuously. Apparatuses and systems including such a treatment vessel are also provided.

8. 发明申请

US20220162535A1 INTEGRATED AND CONTINUOUS RECOMBINANT PROTEIN MANUFACTURING 有权
公开(公告)号：US20220162535A1
公开(公告)日：2022-05-26
申请号：US17599050
申请日：2020-03-27
申请人： Boehringer Ingelheim International GmbH
发明人： Jonathan COFFMAN , Scott A. GODFREY , Raquel OROZCO , Robert Lee FAHRNER , Marcus Andre FIADEIRO , Robert E. KOTTMEIER , Joseph K. McLaughlin , Jeffrey Richard SALM
IPC分类号： C12M1/00 , C12M1/26
摘要： Integrated systems and methods for the manufacturing of recombinant proteins in mammalian cells are provided. The systems and methods include a single-use bioreactor (SUB), a tangential flow filtration system, a column chromatography skid, a tankless hold, a virus inactivation plug flow reactor, and pumps.

9. 发明申请

US20210388308A1 CONTINUOUS FLOW REACTOR FOR VIRAL INACTIVATION 有权
公开(公告)号：US20210388308A1
公开(公告)日：2021-12-16
申请号：US17283285
申请日：2019-10-07
申请人： Boehringer Ingelheim International GmbH
发明人： Raquel OROZCO , Jonathan COFFMAN , Stephanie PARKER , Natira Gnat MATTHEWS
IPC分类号： C12M1/00 , C12M1/12 , C12N7/00
摘要： A continuous flow reactor having a plurality of interwoven flow paths in fluid communication to form a single continuous flow reactor tube having a single flow path.

10. 发明申请

US20170037381A1 METHODS, APPARATUSES, AND SYSTEMS FOR CONTINUOUSLY INACTIVATING A VIRUS DURING MANUFACTURE OF A BIOLOGICAL PRODUCT 审中-公开
标题翻译：在生物制品生产过程中持续灭活病毒的方法，装置和系统
公开(公告)号：US20170037381A1
公开(公告)日：2017-02-09
申请号：US15303776
申请日：2015-04-15
申请人： Boehringer Ingelheim International GmbH
发明人： Jonathan COFFMAN , Jeff GOBY , Scott GODFREY , Raquel OROZCO , Jens Holger VOGEL
IPC分类号： C12N7/00 , A61L2/00
CPC分类号： C12N7/00 , A61L2/0082 , A61L2202/21 , C07K1/14 , C07K1/16 , C12N2710/00063
摘要： Methods for continuously inactivating virus during manufacture of a biological product are provided. The methods include steps of (1) combining (a) a composition including a biological product, and (b) a composition including a virus-inactivation reagent, to obtain (c) a treatment composition having a predetermined property for inactivation of a virus, (2) confirming that the treatment composition exhibits the predetermined property, (3) transferring the treatment composition to a treatment vessel that includes an inlet, an outlet, and a static mixer, the transferring occurring at the inlet, (4) incubating the treatment composition in the treatment vessel at a predetermined temperature while the treatment composition flows at a predetermined rate and contacts the static mixer, and (5) collecting the treatment composition from the treatment vessel at the outlet, wherein steps (1) to (5) are carried out continuously. Apparatuses and systems including such a treatment vessel are also provided.
摘要翻译：提供了在制造生物制品期间连续灭活病毒的方法。所述方法包括以下步骤：（a）包含生物制品的组合物和（b）包含病毒灭活剂的组合物，以获得（c）具有预定的病毒灭活性质的处理组合物，（2）确认处理组合物表现出预定的性能，（3）将处理组合物转移到包括入口，出口和静态混合器的处理容器中，转移发生在入口处，（4）孵育处理在处理组合物以预定速率流动并接触静态混合器时，处理容器中的预定温度下的组成，和（5）在出口处从处理容器收集处理组合物，其中步骤（1）至（5）不断进行。还提供了包括这种处理容器的装置和系统。

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