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Publication Number
US-12065637-B2
Publication Date
2024-08-20
Expiration Date
Abstract
Embodiments described herein generally provide for the scheduled feeding of cells in a cell expansion system. A schedule to proactively and automatically increase and/or maintain inlet rates of media to feed cells may be created, in which inlet rates to the intracapillary portion (or extracapillary portion) of a bioreactor may be increased or maintained according to the schedule. Such schedule may be conservative or aggressive or a combination thereof, for example. Multiple schedules may be used. Scheduled media exchanges may also be included. By following a feed schedule, the monitoring of metabolite levels may be optional. Inlet rates may be increased or maintained without manual manipulation. Media usage may also be more predictable. In an embodiment, a custom task(s) may be created to follow a desired feed schedule. In another embodiment, a pre-programmed task(s) may be used for the scheduled feeding of cells.
Core Innovation
The invention relates to a cell expansion system having a hollow fiber membrane bioreactor configured to receive cells for cell expansion, a processor in communication with the bioreactor, and memory storing a series of instructions for a feed schedule. The system uses a display device to display series of options and to receive user input to create or select a custom task based on media exchange and/or bioreactor rotation.
The core feature is proactive, schedule-based control of media inlet rates to a hollow fiber membrane bioreactor during cell expansion. Media inlet rates to intracapillary and/or extracapillary portions are proactively increased and/or maintained according to one or more predefined schedules, including conservative schedules, aggressive schedules, and mixed schedules, with optional scheduled media exchange and optional bioreactor rotation.
The disclosed approach executes the selected or created schedule by running custom or pre-programmed tasks stored in memory, optionally including stop conditions. In example implementations, the scheduled feeding approach is compared with a metabolite-measurement control approach and reports cell doubling times and harvest yields while noting maintained MSC phenotype and viability and more predictable media usage.
Claims Coverage
The document provides two independent claims that share a core architecture (hollow-fiber membrane bioreactor, processor, memory with stored feed schedule instructions, and a display device) and differ mainly in how instruction sets are created/selected and how commands are executed. The inventive features focus on schedule-driven feeding tasks and instruction-selection based on media exchange and bioreactor rotation.
Schedule-based feed-schedule instructions with display-enabled custom task creation
A cell expansion system includes a hollow fiber membrane bioreactor, a processor, memory configured to store a series of instructions for a feed schedule, and a display device configured to display options corresponding with the series of instructions and receive user input to create a custom task for the feed schedule based on media exchange, bioreactor rotation, or a combination of the media exchange and bioreactor rotation, where the processor executes the custom task.
Instruction-set selection and scheduled feeding execution
A cell expansion system includes a hollow fiber membrane bioreactor, a processor, memory storing a first set and a second set of series of instructions, and a display device presenting options including a first identifier for the first set and a second identifier for the second set, where the processor receives a selection and executes the selected set based on media exchange, bioreactor rotation, or a combination of the media exchange and bioreactor rotation, and where executing the selected set includes executing an operation command to load cells into the bioreactor and executing an operation command to follow a first schedule for feeding the cells.
Overall, claim coverage centers on storing feed schedules as instruction sets, using a display to present options and receive selection or user input, and executing schedule-driven feeding that is based on media exchange and/or bioreactor rotation, optionally including loading cells and following a defined feeding schedule. Dependent claims further specify hollow-fiber inlet targeting into intracapillary and/or extracapillary portions and refine the schedule by using time periods and inlet-rate increases defined by percentages.
Stated Advantages
Improved or comparable harvest yields with more predictable media usage.
Maintained MSC phenotype and viability.
Documented Applications
MSC expansion in a closed, automated hollow-fiber cell expansion system using scheduled feeding approaches compared against metabolite-measurement control approaches.
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