# US 10,870,827 B2 · Configurable methods and systems of growing and harvesting cells in a hollow fiber bioreactor system

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- Number: US 10,870,827 B2
- Document ID: US10870827B2
- Status: Granted
- Kind: B2
- Application number: 15/670,931
- Filed: 2017-08-07
- Published: 2017-11-23
- Granted: 2020-12-22
- Earliest claimed: 2010-10-08
- Assignees: Terumo BCT, Inc.
- Applicants: Terumo BCT, Inc.
- Inventors: Edward Allan Stanton, IV; Glen Delbert Antwiler; Patrick J. Howley; Michael E. Kinzie; Jon A. Dodd; Casey V. Medina
- Web page: https://patentgrep.com/patent/US10870827B2

## CPC

- C12M 41/44: {of volume or liquid level}
- C12M 23/42: {Integrated assemblies, e.g. cassettes or cartridges}
- C12M 23/44: {Multiple separable units; Modules}
- C12M 25/10: {Hollow fibers or tubes (hollow fiber modules in general B01D63/02)}
- C12M 25/12: {the culture medium flowing outside the fiber or tube}
- C12M 29/16: {Hollow fibers (hollow fiber modules in general B01D63/02)}
- C12M 29/20: {Degassing; Venting; Bubble traps (means for collection or storage of gas C12M23/36; gas collection apparatus for laboratory use B01L5/02)}
- C12M 41/48: {Automatic or computerized control (automatic analysis G01N35/00)}
- G06F 8/38: for implementing user interfaces
- C12M: APPARATUS FOR ENZYMOLOGY OR MICROBIOLOGY; {APPARATUS FOR CULTURING MICROORGANISMS FOR PRODUCING BIOMASS, FOR GROWING CELLS OR FOR OBTAINING FERMENTATION OR METABOLIC PRODUCTS, i.e. BIOREACTORS OR FERMENTERS}
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)

## Abstract

Embodiments described herein generally relate to methods and systems for configuring settings of a cell expansion system including a bioreactor. Through a user interface, a user may configure display settings, system settings, and settings associated with protocols for loading, growing and/or harvesting cells. In configuring settings for protocols and associated processes, a diagram view or window of the cell expansion system is displayed in embodiments. The diagram view displays the process settings as graphical user interface elements. Settings available for configuration are enabled for selection in the diagram view. The diagram view allows the user to visualize the settings available for task configuration and to configure enabled settings. Configured settings are stored and capable of retrieval for subsequent execution or modification of the applicable protocol.

## Claims

### Claim 1

A method for configuring a protocol for use with a cell expansion system, the method comprising:
providing the cell expansion system, wherein the cell expansion system executes the protocol;
providing a bioreactor;
providing a user interface for receiving a configuration of the protocol, comprising:
providing a diagram view of the cell expansion system on the user interface, wherein the diagram view is associated with the protocol to be configured, and wherein providing the diagram view comprises:
depicting an intracapillary space of the bioreactor;
depicting an extracapillary space of the bioreactor;
depicting a first direction of a first fluid flow in the intracapillary space with a first visual indicator;
depicting a second direction of a second fluid flow in the extracapillary space with a second visual indicator;
providing a first setting as a first graphical user interface (GUI) element;
enabling the first GUI element for selection;
receiving a first selection of the first GUI element to configure the first setting;
receiving a first value for the first setting; and executing the protocol using the first value for the first setting.

### Claim 2 (depends on 1)

The method as defined in claim 1, wherein the protocol comprises a first process, and wherein the method further comprises:
receiving a second selection to configure the first process;
determining one or more settings associated with the first process, wherein the one or more settings comprises the first setting; and
determining the first setting is configurable.

### Claim 3 (depends on 2)

The method as defined in claim 2, further comprising:
receiving a touch event on a display area of the user interface of the cell expansion system;
determining a location of the touch event;
mapping the location of the touch event to the first GUI element;
determining the first GUI element is associated with the first setting of the first process; and
determining the first GUI element is associated with configuring the first setting of the first process.

### Claim 4 (depends on 1)

The method as defined in claim 1, further comprising:
determining if the first setting is associated with a menu of selection options; and
in response to determining the first setting is associated with the menu of selection options, providing the menu of selection options in the diagram view to receive a second selection.

### Claim 5 (depends on 1)

The method as defined in claim 1, further comprising:
determining the first setting is associated with a numeric value;
in response to determining the first setting is associated with the numeric value, providing a data entry pad in the diagram view to receive the first value;
receiving, at the data entry pad, the first value for the first setting; and
displaying the first value with the first GUI element in the diagram view.

### Claim 6 (depends on 5)

The method as defined in claim 5, further comprising:
receiving an indication to store the first value for the first setting; and
storing the first value for the first setting.

### Claim 7 (depends on 6)

The method as defined in claim 6, further comprising:
receiving an indication to execute the protocol;
retrieving the stored first value for the first setting; and
executing the protocol using the stored first value for the first setting.

### Claim 8 (depends on 5)

The method as defined in claim 5, further comprising:
determining to calculate a second value for a second setting based on the first value for the first setting;
automatically calculating the second value; and
displaying the second value in association with a second GUI element in the diagram view.

### Claim 9 (depends on 8)

The method as defined in claim 8, wherein the first setting comprises an inlet rate, and wherein the second setting comprises a circulation rate.

### Claim 10 (depends on 8)

The method as defined in claim 8, further comprising:
indicating, in the diagram view, that the second setting is not configurable.

### Claim 11 (depends on 1)

The method as defined in claim 1, wherein enabling the first GUI element for selection comprises:
associating a first visual indicia with the first GUI element;
determining the first setting is configurable; and
in response to determining the first setting is configurable, associating a second visual indicia with the first GUI element.

### Claim 12 (depends on 11)

The method as defined in claim 11, further comprising:
associating the first setting with the first GUI element;
rendering the first GUI element, wherein the first GUI element is enabled; and
displaying the first GUI element.

### Claim 13 (depends on 1)

The method as defined in claim 1, wherein providing the diagram view of the cell expansion system further comprises:
depicting a third direction of a process flow between the intracapillary space of the bioreactor and the extracapillary space of the bioreactor, wherein the process flow is associated with a first process.

### Claim 14

A cell expansion system, the system comprising:
a bioreactor;
a processor;
a display device, in communication with the processor, operable to display data; and
a memory, in communication with and readable by the processor, and containing a series of instructions that, when executed by the processor, cause the processor to:
provide a diagram view of the cell expansion system on the display device, wherein the diagram view is associated with a protocol to be configured on the cell expansion system, comprising:
depict an intracapillary space of the bioreactor;
depict an extracapillary space of the bioreactor;
depict a first direction of a first fluid flow in the intracapillary space with a first visual indicator;
depict a second direction of a second fluid flow in the extracapillary space with a second visual indicator;
provide a first setting as a first graphical user interface (GUI) element;
receive a first selection of the first GUI element to configure the first setting;
receive an input associated with the first GUI element; and
execute the protocol, using the input for the first setting, with the cell expansion system.

### Claim 15 (depends on 14)

The system of claim 14, further comprising:
enable the first GUI element for selection, comprising:
associate a first visual indicia with the first GUI element;
determine the first setting is configurable; and
in response to determining the first setting is configurable, associate a second visual indicia with the first GUI element.

### Claim 16 (depends on 15)

The system of claim 15, further comprising:
receive a second selection from a list of one or more pre-defined selection options; and
display the selected pre-defined selection option in association with the first GUI element in the diagram view.

### Claim 17 (depends on 16)

The system of claim 16, wherein one or more display settings comprises a language for use in displaying text in a view of the cell expansion system.

### Claim 18 (depends on 17)

The system of claim 17, wherein a system setting comprises a low-temperature alarm, and wherein the memory, in communication with and readable by the processor, and containing a series of instructions that, when executed by the processor, cause the processor to:
receive a first indication to configure the low-temperature alarm, wherein the configuring further causes the processor to:
receive a second indication to configure a low-temperature alarm setting;
receive a third indication to store the low-temperature alarm setting configuration; and
in response to receiving the third indication to store, store the low-temperature alarm setting configuration.

### Claim 19

A non-transitory processor-readable storage medium storing executable instructions which, when executed by a processor, perform a method of configuring a cell expansion system, the method comprising:
receiving an indication, in a user interface of a display device associated with the cell expansion system, to configure a protocol for use with the cell expansion system, wherein the cell expansion system comprises a bioreactor;
in response to receiving the indication, providing a diagram view of the cell expansion system on the user interface, wherein the diagram view is associated with the protocol to be configured, and wherein providing the diagram view comprises:
depicting an intracapillary side of the bioreactor;
depicting an extracapillary side of the bioreactor;
depicting a first direction of a first fluid flow in the intracapillary side with a first visual indicator;
depicting a second direction of a second fluid flow in the extracapillary side with a second visual indicator;
providing a first setting as a first graphical user interface (GUI) element;
enabling the first GUI element for selection;
receiving a first selection of the first GUI element to configure the first setting;
receiving a first value for the first setting; and
executing the protocol using the first value for the first setting.

### Claim 20 (depends on 19)

The non-transitory processor-readable storage medium as defined in claim 19, wherein the protocol comprises a first process, and wherein providing the diagram view further comprises:
depicting a third direction of a process flow between the intracapillary side of the bioreactor and the extracapillary side of the bioreactor, wherein the process flow is associated with the first process.
