Customizable methods and systems of growing and harvesting cells in a hollow fiber bioreactor system

• US 10,669,519 B2
• Filed: 05/31/2017
• Issued: 06/02/2020
• Est. Priority Date: 10/08/2010
• Status: Active Grant

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Inventors: Stanton, IV, Edward Allan, Antwiler, Glen Delbert, Howley, Patrick J., Kinzie, Michael E., Dodd, Jon A., Medina, Casey V.
• Primary Examiner(s): Sasaki, Shogo
• Application Number:
  US15/610,224
• Publication Number:
  US 20170267966A1
• Time in Patent Office: 1,098 Days
• CPC Class Codes: C12M 23/42 Integrated assemblies, e.g. cassettes or cartridges
• CPC Class Codes: C12M 23/44 Multiple separable units; Modules
• CPC Class Codes: C12M 25/10 Hollow fibers or tubes hollow fiber modules in general B01D63/02
• CPC Class Codes: C12M 25/12 the culture medium flowing outside the fiber or tube
• CPC Class Codes: C12M 29/16 Hollow fibers hollow fiber modules in general B01D63/02
• CPC Class Codes: C12M 29/20 Degassing; Venting; Bubble traps means for collection or storage of gas C12M23/36; gas collection apparatus for laboratory use B01L5/02
• CPC Class Codes: C12M 41/44 of volume or liquid level
• CPC Class Codes: C12M 41/48 Automatic or computerized control automatic analysis G01N35/00
• CPC Class Codes: G06F 8/38 for implementing user interfaces

Abstract

Embodiments described herein generally relate to methods and systems for customizing protocols for use with a cell expansion system. Through a user interface, a user may create a custom task for loading, growing and/or harvesting cells. A custom task may comprise one or more steps, in which a user may add or omit steps, as desired. Data may be entered for settings associated with a custom task, in which embodiments provide for such data to be entered each time the custom task is performed. In another embodiment, the settings for a custom task may be configured, in which such settings may be stored and retrieved upon selection of the custom task. Customization and configuration of a custom task may occur using a diagram view of the cell expansion system, in which process settings are associated with graphical user interface elements.

Claims

1. A method for customizing a task for use with a cell expansion system, the method comprising:

providing a bioreactor in the cell expansion system;

providing a user interface, wherein the user interface is operable to display data and receive user input;

providing a memory;

providing a processor in communication with the user interface and the memory;

the processor receiving, through the user interface, a first selection to create a first custom task for expanding a plurality of cells in the bioreactor;

in response to the receiving the first selection, the processor;

providing, through the user interface, one or more types of steps to add for the first custom task;

receiving, through the user interface, a second selection of a first step for the first custom task;

in response to the receiving the second selection, retrieving, from the memory, one or more settings for the first step;

displaying, through the user interface, the one or more settings for the first step;

receiving, through the user interface, a third selection to modify the one or more settings for the first step;

in response to the third selection, providing, through the user interface, a diagram view of the cell expansion system for customizing the first step, comprising;

associating the diagram view with the first step in the user interface;

providing a first setting of the one or more settings as a first graphical user interface element for selection in the user interface;

receiving, through the user interface, a fourth selection of the first graphical user interface element;

receiving, through the user interface, a value for the first graphical user interface element;

receiving an indication to execute the first custom task; and

executing the first custom task using the received value for the first setting to expand the plurality of the cells.

2. The method as defined in claim 1, wherein the user interface is a touch screen, and wherein the receiving, through the user interface, a first selection to create the first custom task comprises:

receiving a touch event on the touch screen, wherein the touch screen comprises a display area;

determining a location of the touch event;

mapping the location of the touch event to the first graphical user interface element; and

determining the first graphical user interface element is associated with the first setting.

3. The method as defined in claim 2, wherein the touch screen comprises an input device that can receive one or more touch events.

4. The method as defined in claim 1, further comprising:

determining whether the first setting is associated with a numeric value; and

if the first setting is associated with the numeric value, providing a data entry pad in the diagram view to receive the numeric value.

5. The method as defined in claim 4, further comprising:

if the first setting is not associated with the numeric value, determining if the first setting is associated with a menu of selection options; and

if the first setting is associated with the menu of selection options, providing the menu of selection options in the diagram view.

6. The method as defined in claim 4, further comprising:

receiving, through the data entry pad, the numeric value for modifying the first setting; and

storing the received numeric value for modifying the first setting.

7. The method as defined in claim 1, wherein the first setting comprises one or more from the group consisting of:

intracapillary inlet, intracapillary inlet rate, intracapillary circulation rate, extracapillary inlet, extracapillary inlet rate, extracapillary circulation rate, rocker, and stop condition.

8. The method as defined in claim 1, wherein the providing the first setting of the one or more settings as the first graphical user interface element for selection comprises:

enabling the first graphical user interface element for selection.

9. The method as defined in claim 1, wherein the one or more types of steps to add for the first custom task comprises one or more from the group consisting of:

wash out lines, wash out lines through membrane, wash rapidly, harvest cells, add bolus, and custom.

10. The method as defined in claim 1, further comprising:

receiving a fifth selection to add a second step to the first custom task.

11. The method as defined in claim 10, the processor further:

providing, through the user interface, a second diagram view of the cell expansion system for customizing the second step, comprising;

associating the second diagram view with the second step in the user interface.

12. The method as defined in claim 8, wherein the enabling the first graphical user interface element for selection comprises:

associating a first visual indicator with the first graphical user interface element; and

in response to determining the first setting can be modified, associating a second visual indicator with the first graphical user interface element.

13. The method as defined in claim 1, wherein the bioreactor comprises a hollow fiber membrane.

14. The method as defined in claim 13, wherein the providing, through the user interface, the diagram view of the cell expansion system for customizing the first step further comprises:

depicting an intracapillary space of the bioreactor in the diagram view; and

depicting an extracapillary space of the bioreactor in the diagram view.