Method and apparatus for antibody production and purification
Inventors
HIRSCHEL, Mark • Wojciechowski, Robert J. • Adams, Grant • Page, Darrell P. • ARNESON, KIMBERLY • JORGENSEN, JEFF • WANIGER, SCOTT
Assignees
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Publication Number
US-10093956-B2
Publication Date
2018-10-09
Expiration Date
Abstract
The subject invention pertains to methods and apparatus for the production and purification of cell products, such as immunoglobulins. One aspect of the invention is an integrated cell culture and purification apparatus for the growth and maintenance of cells and the harvest and purification of cell products, such as immunoglobulins. Thus, the apparatus integrates a cell culture function with a purification function. Other aspects of the invention pertain to an automated method for producing immunogenic compositions such as vaccines.
Core Innovation
The invention relates to an automated cell culture and purification apparatus for the production of cells and cell derived products. The apparatus combines a cell culture unit and a purification unit connected by a fluid flow path, and the cell culture unit includes a first reusable instrumentation base device with hardware comprising a pump and at least one first disposable cell cultureware module removably attachable to the first instrumentation base device.
In the cell culture unit, the disposable cell cultureware module includes a cell growth chamber with ports for movement of cell culture medium through the cell growth chamber, and the pump circulates cell culture medium into and out of the cell growth chamber through the ports. The purification unit includes a second reusable instrumentation base device with hardware to receive fluid from the cell growth chamber through the fluid flow path, where the hardware comprises dual pumps for chromatography and a plurality of valves.
The purification unit further includes at least one second disposable cell cultureware module removably attachable to the second instrumentation base device, where the disposable module includes a chromatography device, a diafiltration module that utilizes tangential flow filtration, an anion exchange filter, and a size-exclusion virus filter. The system is configured to separate components and virus using a purification sequence including chromatography, tangential flow diafiltration, anion exchange filtration, and size-exclusion virus filtration connected to the cell growth chamber by a fluid flow path.
Claims Coverage
The document includes one independent claim (clm-00001). It recites an automated apparatus having a cell culture unit and a purification unit, with specific reusable instrumentation bases and disposable cultureware modules connected by a fluid flow path; the purification unit defines a component/virus separation sequence including chromatography, tangential flow diafiltration, anion exchange filtration, and size-exclusion virus filtration, implemented with dual pumps for chromatography and a plurality of valves.
Automated integrated cell culture and purification apparatus with reusable bases and disposable modules
An automated cell culture and purification apparatus for production of cells and cell derived products, comprising a cell culture unit and a purification unit connected by a fluid flow path, where the cell culture unit uses a first reusable instrumentation base device with a pump and at least one first disposable cell cultureware module with a cell growth chamber having ports for movement of cell culture medium, and where the purification unit uses a second reusable instrumentation base device and at least one second disposable cell cultureware module including downstream separation components.
Disposable cell growth chamber circulated by pump through ports
A first disposable cell cultureware module includes a cell growth chamber having ports for movement of cell culture medium through the cell growth chamber, and the pump circulates cell culture medium into and out of the cell growth chamber through the ports.
Dual-pump chromatography hardware with valves in the purification instrumentation base
The purification unit includes a second reusable instrumentation base device incorporating hardware to receive fluid from the cell growth chamber through the fluid flow path, where the hardware comprises dual pumps for chromatography and a plurality of valves.
Chromatography, tangential flow diafiltration, anion exchange filtration, and size-exclusion virus filtration as a connected separation sequence
At least one second disposable cell cultureware module includes a chromatography device, a diafiltration module utilizing tangential flow filtration, an anion exchange filter, and a size-exclusion virus filter, with the chromatography device separating a component from fluid received from the cell growth chamber; the diafiltration module separating a component from fluid received from the chromatography device; the anion exchange filter separating a component from fluid received from the diafiltration module or the chromatography device; and the size-exclusion virus filter separating virus from fluid received from the chromatography device, the diafiltration module, or the anion exchange filter.
Across the independent claim, the core claim coverage is the combination of reusable instrumentation bases with removable disposable cultureware modules, where a pump-circulated cell growth chamber connects via a fluid flow path to a downstream purification sequence that uses chromatography, tangential flow diafiltration, anion exchange filtration, and size-exclusion virus filtration, implemented with dual pumps for chromatography and valves.
Stated Advantages
Documented Applications
No documented applications found
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