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1. 发明申请

US20210017561A1 CONTINUOUS PROCESSING METHODS FOR BIOLOGICAL PRODUCTS 有权
公开(公告)号：US20210017561A1
公开(公告)日：2021-01-21
申请号：US17030731
申请日：2020-09-24
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Thomas C. Ransohoff , Marc A. T. Bisschops
IPC分类号： C12P21/00 , C12M1/00 , C07K1/36 , C07K16/00 , B01D15/18 , B01D15/38
摘要： The present invention is directed to the development of continuous processing technology for the purification of biopharmaceuticals and biological products, such as monoclonal antibodies, protein therapeutics, and vaccines. Methods for continuous processing of a biological product in a feed stream toward formulation of a purified bulk product are described.

2. 发明公开

US20240085388A1 OPTIMIZING OPERATING BINDING CAPACITY FOR A MULTIPLE COLUMN CHROMATOGRAPHY PROCESS 审中-公开
公开(公告)号：US20240085388A1
公开(公告)日：2024-03-14
申请号：US18506451
申请日：2023-11-10
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Xhorxhi Gjoka , Karl K. Rogler , Mark J. Schofield
IPC分类号： G01N30/86 , B01D15/18 , G01N30/46
CPC分类号： G01N30/8658 , B01D15/1864 , G01N30/461 , G01N30/46 , G01N30/86 , G01N2030/889
摘要： Methods for optimizing operating binding capacity for a multiple column chromatography (MCC) process are disclosed.

3. 发明授权

US11835501B2 Optimizing operating binding capacity for a multiple column chromatography process 有权
公开(公告)号：US11835501B2
公开(公告)日：2023-12-05
申请号：US14797785
申请日：2015-07-13
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Xhorxhi Gjoka , Karl K. Rogler , Mark J. Schofield
IPC分类号： G01N30/86 , G01N30/88 , B01D15/18 , G01N30/46
CPC分类号： G01N30/8658 , B01D15/1864 , G01N30/461 , G01N30/46 , G01N30/86 , G01N2030/889
摘要： Determining optimum operating binding capacity for a MCC process using one column, the process including N number of columns, comprises

loading target product on a first column at a first residence time and/or flow rate;
loading the product on the column at a second residence time and/or flow rate, the first residence time and/or flow rate being different than the second residence time and/or flow rate;
generating a first breakthrough curve for the first residence time and/or flow rate and a second breakthrough curve for the second residence time and/or flow rate, wherein the first curve represents product breakthrough for the first column and the second curve represents product breakthrough for an Nth column; and
using the curves to determine product loading capacity of the first column before product breakthrough at the Nth column; the product loading capacity of the first column equaling optimum operating binding capacity for the process.

4. 发明申请

US20230078364A1 VALVE SETUP FOR CHROMATOGRAPHY AND FLUID MANAGEMENT SYSTEMS 有权
公开(公告)号：US20230078364A1
公开(公告)日：2023-03-16
申请号：US17476463
申请日：2021-09-15
申请人： SARTORIUS STEDIM CHROMATOGRAPHY SYSTEMS LTD.
发明人： Dinesh Shukla
IPC分类号： B01D15/10 , F16K15/14 , F16K27/02
摘要： An assembly is provided that comprises at least one valve unit (20, 30) comprising a plurality of valves (25), the at least one valve unit (20, 30) having a plurality of valve unit protrusions (32) extending in a first direction and at least one valve unit fastener-engaging component (36); a valve control block (10) configured to open and close the plurality of valves (25), the valve control block (10) comprising a plurality of pins (15) extending in the first direction (A); and at least one thrust plate (40) comprising a plurality of thrust plate protrusions (42), a plurality of thrust plate apertures (44) configured to receive the plurality of pins (15) and at least one thrust plate fastener-engaging component (46); wherein: the at least one valve unit (20, 30) further comprises a plurality of fitted through-holes configured to receive the plurality of pins (15) and the at least one valve unit (20, 30) is positioned adjacent to the valve control block (10) in the first direction (A); the at least one thrust plate (40) is positioned adjacent to the at least one valve unit (20, 30) in the first direction (A) such that the plurality of thrust plate protrusions (42) face the plurality of valve unit protrusions (32); the at least one valve unit fastener-engaging component (36) and the at least one thrust plate fastener-engaging component (46) are configured to be separated by an engagement distance along a second direction (B) perpendicular to the first direction (A) and are configured to be engaged by a fastener (50) to reduce the engagement distance such that the at least one thrust plate (40) and the at least one valve unit (20, 30) at least partially move relative to each other along the second direction (B); the plurality of pins (15) and the plurality of thrust plate apertures (44) are configured such that the position of the at least one thrust plate (40) with respect to the first direction (A) is fixed relative to the plurality of pins (15); and the valve unit protrusions (32) and the thrust plate protrusions (42) are configured such that the relative motion along the second direction (B) is translated into a force on the at least one valve unit (20, 30) in a direction opposite the first direction (A).

5. 发明公开

US20230375101A1 VALVE SETUP FOR SMB CHROMATOGRAPHY 审中-公开
公开(公告)号：US20230375101A1
公开(公告)日：2023-11-23
申请号：US17749928
申请日：2022-05-20
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Dinesh Shukla
IPC分类号： B01D15/18 , F16K27/12
CPC分类号： B01D15/1842 , F16K27/12
摘要： An assembly is provided that comprises:

a valve cassette block (20) comprising a plurality of valves (25) which are controllable via a control surface (24) of the valve cassette block (20);
a valve control block (10) having an operation surface (11), the valve control block (10) being configured to control each of the plurality of valves when the operation surface (11) is in close contact with the control surface (24) of the valve cassette block (20) in an operation position;
at least one swiveling door (30) hinged to the valve control block (20) such that an open state of the swiveling door (30) allows arranging the valve cassette block (20) into the operation position with its control surface (24) arranged at the operation surface (11) of the valve control block, while a closed position of the swiveling door (30) is configured to hold the valve cassette block (20) in the operation position with an inner surface of the swiveling door (30) abutting a rear surface (26) of the valve cassette block (20) opposite to its control surface (24); and
at least one flexible pressurizing tube (45) arranged at the inner surface of the swiveling door (30) such that the pressurizing tube presses against the rear surface (26) of the valve cassette block (20), when the pressure in the pressurizing tube (45) is increased.

6. 发明授权

US12018765B2 Valve setup for SMB chromatography 有权
公开(公告)号：US12018765B2
公开(公告)日：2024-06-25
申请号：US17738359
申请日：2022-05-06
申请人： SARTORIUS STEDIM CHROMATOGRAPHY SYSTEMS LTD.
发明人： Dinesh Shukla
IPC分类号： F16K27/02 , B01D15/18 , F16K31/06
CPC分类号： F16K27/0236 , B01D15/1842 , F16K31/06
摘要： An assembly is provided that comprises:

at least one valve cassette block (20) comprising a plurality of valves (25) which are controllable via a control surface (24) of the valve cassette block (20);
a valve control block (10) having an operation surface (11), the valve control block (10) being configured to control each of the plurality of valves (25) when the operation surface (11) is in contact with the control surface (24) of the at least one valve cassette block (20), the valve control block (10) comprising at least one sliding trench (14) formed in the operation surface (11);
at least one sliding component (30) configured to slidably interlock with the at least one sliding trench (14) such that the at least one sliding component (30) is movable relative to the valve control block (10) in a sliding direction parallel to the operation surface (11),
at least one pulling bracket (40, 50) configured to embrace the at least one valve cassette block (20) and to interact with the at least one sliding component (30) such that a sliding movement of the at least one sliding component (30) in the at least one sliding trench (14) causes the pulling bracket (40, 50) to pull the at least one valve cassette block (20) with its control surface (24) against the operation surface (11) of the valve control block (10).

7. 发明授权

US12012629B2 Continuous processing methods for biological products 有权
公开(公告)号：US12012629B2
公开(公告)日：2024-06-18
申请号：US17030731
申请日：2020-09-24
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Thomas C. Ransohoff , Marc A. T. Bisschops
IPC分类号： C12M3/00 , B01D15/18 , B01D15/38 , B01L1/00 , C07K1/36 , C07K16/00 , C12M1/00 , C12P21/00 , G01N30/02
CPC分类号： C12P21/00 , B01D15/1821 , B01D15/3804 , C07K1/36 , C07K16/00 , C12M23/44 , C12M47/10 , C12M47/12 , G01N30/02
摘要： The present invention is directed to the development of continuous processing technology for the purification of biopharmaceuticals and biological products, such as monoclonal antibodies, protein therapeutics, and vaccines. Methods for continuous processing of a biological product in a feed stream toward formulation of a purified bulk product are described.

8. 发明公开

US20230277958A1 METHOD FOR OPERATING A CHROMATOGRAPHY SETUP 审中-公开
公开(公告)号：US20230277958A1
公开(公告)日：2023-09-07
申请号：US17687237
申请日：2022-03-04
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Fabrizio Pelella , Jason Forte , Mark Allen Pagkaliwangan
IPC分类号： B01D15/18 , B01D15/22 , B01D15/14
CPC分类号： B01D15/1828 , B01D15/14 , B01D15/1842 , B01D15/1864 , B01D15/22
摘要： A method for operating a chromatography setup of a bioprocess installation with a plurality of chromatography columns, each with a column inlet and a column outlet, and a valve switching cassette with a group of inlet ports, a group of outlet ports, a group of column-in ports and a group of column-out ports . It is prosed, that a first liquid stream of concentrated buffer is introduced into a first internal liquid line via a first inlet port and that a second liquid stream of diluent is introduced into a second internal liquid line via a second inlet port, that in a dilution process, the array of valve units is switched as to create a third liquid stream by merging the first liquid stream and the second liquid stream at a merging location within the valve switching cassette.

9. 发明授权

US11879561B2 Valve setup for SMB chromatography 有权
公开(公告)号：US11879561B2
公开(公告)日：2024-01-23
申请号：US17749928
申请日：2022-05-20
申请人： Sartorius Stedim Chromatography Systems Ltd.
发明人： Dinesh Shukla
IPC分类号： B01D15/18 , F16K27/12 , F16K27/02
CPC分类号： F16K27/12 , B01D15/1842 , F16K27/029 , F16K27/0236
摘要： A valve setup for SMB chromatography includes a cassette block, a control block, a swiveling door, and a flexible pressurizing tube. The cassette block is configured to control each of a plurality of valves when an operation surface is in close contact with a control surface of the cassette block. The swiveling door is hinged to the valve control block such that an open state of the door arranges the cassette block such that the control surface is at the operation surface of the control block, and a closed position holds the cassette block with an inner surface of the swiveling door abutting a rear surface of the cassette block opposite the control surface. The flexible pressurizing tube is arranged at the inner surface of the swiveling door so the pressurizing tube presses against the rear surface of the cassette block when the pressure in the tube is increased.

10. 发明公开

US20230356108A1 VALVE SETUP FOR SMB CHROMATOGRAPHY 审中-公开
公开(公告)号：US20230356108A1
公开(公告)日：2023-11-09
申请号：US17738359
申请日：2022-05-06
申请人： SARTORIUS STEDIM CHROMATOGRAPHY SYSTEMS LTD.
发明人： Dinesh Shukla
IPC分类号： B01D15/18 , F16K31/06 , F16K7/12
CPC分类号： B01D15/1842 , F16K31/06 , F16K7/12
摘要： An assembly is provided that comprises:

at least one valve cassette block (20) comprising a plurality of valves (25) which are controllable via a control surface (24) of the valve cassette block (20);
a valve control block (10) having an operation surface (11), the valve control block (10) being configured to control each of the plurality of valves (25) when the operation surface (11) is in contact with the control surface (24) of the at least one valve cassette block (20), the valve control block (10) comprising at least one sliding trench (14) formed in the operation surface (11);
at least one sliding component (30) configured to slidably interlock with the at least one sliding trench (14) such that the at least one sliding component (30) is movable relative to the valve control block (10) in a sliding direction parallel to the operation surface (11),
at least one pulling bracket (40, 50) configured to embrace the at least one valve cassette block (20) and to interact with the at least one sliding component (30) such that a sliding movement of the at least one sliding component (30) in the at least one sliding trench (14) causes the pulling bracket (40, 50) to pull the at least one valve cassette block (20) with its control surface (24) against the operation surface (11) of the valve control block (10).

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