Method and system for the production of cells and cell products and applications thereof
Inventors
Wojciechowski, Robert J. • Page, Darrell P. • Bongers, Karl Patrick • WANIGER, SCOTT • Norris, Beverly • HIRSCHEL, Mark • Wong, Thiem Chan Duong • Adams, Grant • Crep, Martin Peder • Gramer, Michael J.
Assignees
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Publication Number
US-10723993-B2
Publication Date
2020-07-28
Expiration Date
Abstract
A cell culture system for the production of cells and cell derived products includes a reusable instrumentation base device incorporating hardware to support cell culture growth. A disposable cultureware module including a cell growth chamber is removably attachable to the instrumentation base device. The base device includes microprocessor control and a pump for circulating cell culture medium through the cell growth chamber. The cultureware module is removably attached to the instrumentation base device. Cells are introduced into the cell growth chamber and a source of medium is fluidly attached to the cultureware module. Operating parameters are programmed into the microprocessor control. The pump is operated to circulate the medium through the cell growth chamber to grow cells or cell products therein. The grown cells or cell products are harvested from the cell growth chamber and the cultureware module is then disposed.
Core Innovation
The invention relates to a cell culture system for the production of cells and cell derived products that combines a reusable instrumentation base device with at least one disposable cell cultureware module removably attachable to the instrumentation base device. The reusable base device incorporates mechanical and electrical hardware to support cell culture growth, while the disposable cultureware module includes a cell growth chamber and a plurality of mechanical and electrical interfaces. When the cultureware module is positioned on the instrumentation base device, the mechanical and electrical interfaces mate with the base hardware to provide a functional integrated system for culture operations.
The instrumentation base device further includes air ports and a heater, and the disposable cultureware module includes an inlet and outlet port constructed and arranged to align with the air ports. The alignment enables the heater of the instrumentation base device to blow warmed air into the cultureware module from the instrumentation base device. The system is described as automated and closed, including microprocessor control and components for driving and maintaining culture operations in an enclosed configuration for growth and harvest.
The system further includes gas exchange for oxygen and carbon dioxide management, with sensing and feedback related to cell culture conditions using pH sensing and feedback, including indirect lactate control based on carbon dioxide and pH as described in the summary. In addition, the cultureware module is described as including automated fluid control and measurement components such as multi-channel peristaltic pumping and automated fluid valving/tubing occlusion. The overall system integrates these functions through the removable disposable cultureware module and the reusable instrumentation base device, including batch-record automation using barcode reader connectivity and MES/LIMS integration as described.
Claims Coverage
The document includes one independent claim covering a cell culture system architecture defined by a reusable instrumentation base device that mates with a disposable cultureware module, with aligned warmed-air delivery via air ports and a heater as a central limitation. Dependent claim coverage extends the system with specific cultureware embodiments and subsystem features, including a hollow-fiber bioreactor, fluid cycling structures, and sensing and gas-exchange components.
Reusable instrumentation base with mating mechanical and electrical interfaces
A reusable instrumentation base device incorporating mechanical and electrical hardware to support cell culture growth; and at least one disposable cell cultureware module removably attachable to said instrumentation base device, said at least one cultureware module having a plurality of mechanical and electrical interfaces, and said at least one cultureware module including a cell growth chamber, such that when said at least one cultureware module is positioned on said instrumentation base device said plurality of mechanical and electrical interfaces of said at least one cultureware module mate with said mechanical and electrical hardware of said instrumentation base device.
Aligned warmed-air delivery from heater through cultureware inlet and outlet ports
The instrumentation base device further includes air ports, and a heater, and wherein said at least one cultureware module includes an inlet and outlet port, said inlet and outlet ports being constructed and arranged to align with said air ports of said instrumentation base device such that said heater blows warmed air into said at least one cultureware module from said instrumentation base device.
Hollow-fiber cell growth chamber with semi-permeable hollow fibers
The cell growth chamber comprises a hollow-fiber bioreactor with a plurality of semi-permeable hollow fibers.
Fluid cycling unit with non-rigid and flexible reservoirs
The cultureware module includes a fluid cycling unit with a non-rigid reservoir and a second flexible reservoir in fluid communication to cycle and maintain fluid volumes and create elevated pressure in the first reservoir.
Gas exchange cartridge with oxygen and carbon dioxide sensing
A gas blending mechanism includes a gas exchange cartridge that provides oxygen and adds/removes carbon dioxide, and a carbon dioxide sensor measures carbon dioxide level at the cartridge discharge end.
Sensors for fluid circulation rate, temperature, and pH
The cultureware module includes sensors for sensing fluid circulation rate, temperature and pH of the cell culture medium.
Overall, the claim set coverage centers on a modular system in which a reusable instrumentation base device mates mechanically and electrically with a disposable cultureware module, with warmed air delivered into the cultureware via aligned air ports and module inlet/outlet ports. Dependent coverage further specifies a hollow-fiber bioreactor, a fluid cycling unit using non-rigid and flexible reservoirs, and sensing and gas-exchange cartridge elements for oxygen/carbon dioxide management along with pH, temperature, and flow sensing.
Stated Advantages
Automated and closed cell culture system for production of cells and cell derived products.
Integration of warmed-air delivery through aligned air ports and heater to regulate conditions within the disposable cultureware module.
Documented Applications
Autologous patient cell expansion.
Genetically modified cells.
Monoclonal antibody production.
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