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-9441195-B2
Publication Date
2016-09-13
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. The system comprises a reusable instrumentation base device incorporating hardware to support cell culture growth and at least one disposable cell cultureware module removably attachable to the instrumentation base device. The disposable module includes a cell growth chamber and rotary actuator valve(s) for controlling circulation of cell culture medium through elastomer medium flow circuit(s).
The rotary actuator valve is defined by a housing having an inner passage and at least one port for receiving the elastomer medium flow circuit. A valve body with first and second ends is located within the inner passage and is rotatable about a longitudinal axis within the valve housing. The valve body includes a plurality of cam surfaces and angular sections along a length thereof to sequentially compress and open the elastomer medium flow circuit as the valve body rotates within the valve housing, where the cam surfaces compress the elastomer medium flow circuit by direct contact with a segment of the elastomer medium flow circuit.
Additional concepts are combined with the disposable cultureware module and the reusable base, including gas exchange cartridge control for oxygen and carbon dioxide off-gas, cultureware-integrated pH sensing, and lactate control using CO2 and pH-based calculation feeding back to media dilution/perfusion rate. The cultureware module further includes an extra-capillary (EC) fluid cycling unit with non-rigid, pressure-actuated flexible reservoirs for level control without ultrasonic/load cells, and automated rotary valving/clamping for fluid switching in elastomer media circuits.
Claims Coverage
The independent claim identifies a cell culture system architecture combining a reusable instrumentation base and a disposable cultureware module, with one rotary actuator valve that sequentially compresses and opens elastomer medium flow circuits via cam surfaces. Within the provided excerpt, only one independent claim is explicitly listed (clm-00001).
Reusable instrumentation base with disposable cultureware module
A cell culture system for the production of cells and cell derived products comprising a reusable instrumentation base device incorporating hardware to support cell culture growth; and at least one disposable cell cultureware module removably attachable to said instrumentation base device, said module including a cell growth chamber.
Rotary actuator valve with cam surfaces sequentially compressing elastomer medium flow circuits
At least one rotary actuator valve for controlling circulation of cell culture medium through at least one elastomer medium flow circuit in said cultureware module, said at least one rotary actuator valve including a housing having an inner passage and at least one port for receiving the at least one elastomer medium flow circuit, and a valve body having first and second ends located within said inner passage of said valve housing and rotatable about a longitudinal axis within said valve housing, said valve body including a plurality of cam surfaces and angular sections along a length thereof to sequentially compress and open the at least one elastomer medium flow circuit as said valve body rotates within said valve housing, wherein said plurality of cam surfaces compresses the at least one elastomer medium flow circuit by making direct contact with a segment of the at least one elastomer medium flow circuit.
Based on the provided excerpt, claim coverage centers on a two-part architecture with a reusable base and removable disposable cultureware, and a rotary actuator valve structure where cam surfaces on a rotatable valve body sequentially compress and open elastomer medium flow circuits via direct cam contact.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Regulated autologous/patient-specific cell therapies using expanded cell types including immune cells, chondrocytes, stem/progenitor cells, and genetically modified cells.
Improved harvest/viability via a flexible hollow-fiber bioreactor design [procedural detail omitted for safety].
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