# US 12,110,481 B2 · Method and system for creating reconfigurable bio-processing workflows

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- Number: US 12,110,481 B2
- Document ID: US12110481B2
- Status: Granted
- Kind: B2
- Application number: 16/607,516
- Filed: 2018-04-18
- Published: 2020-04-30
- Granted: 2024-10-08
- Earliest claimed: 2017-04-28
- Assignees: Cytiva Sweden AB
- Applicants: Cytiva Sweden AB
- Inventors: Victor Jose; Andreas Axen; Klaus Gebauer; Veena B N Rao; Patric Fricking; Hanish Lakhani
- Web page: https://patentgrep.com/patent/US12110481B2

## CPC

- C12M 41/48: {Automatic or computerized control (automatic analysis G01N35/00)}
- C12M 23/26: {flexible (flexible containers for laboratory use B01L3/505)}
- C12M 23/28: {disposable or single use}
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- 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}
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

A bio-processing system (100) is presented. The bio-processing system (100) includes one or more bio-processing units (110-114), one or more process supporting devices (116, 118), one or more sensors (120-132), and a bio-processing workflow controller (104) wirelessly coupled to at least one of the one or more bio-processing units (110-114), the one or more process supporting devices (116, 118), and the one or more sensors (120-132). The bio-processing workflow controller (104) includes a processor (202) configured to create a reconfigurable bio-processing workflow, and where the reconfigurable bio-processing workflow is representative of an arrangement of one or more of the one or more bio-processing units (110-114), the one or more process supporting devices (116, 118), and the one or more sensors (120-32) to perform at least one bio-processing operation.

## Claims

### Claim 1

A bio-processing system, comprising:
one or more bio-processing units comprising a bioreactor for cell cultivation, configured to perform at least one bio-processing operation;
one or more process supporting devices, selected from a pump, a weighing scale, a flow restriction clamp, a temperature management device, or a combination thereof, operatively coupled to the one or more bio-processing units, wherein the one or more process supporting devices are configured to aid the one or more bio-processing units in performing the at least one bio-processing operation;
one or more sensors operatively coupled to at least one of the one or more bio-processing units and the one or more process supporting devices;
a bio-processing workflow controller wirelessly coupled to at least one of the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors, wherein the bio-processing workflow controller comprises:
a processor configured to create a reconfigurable bio-processing workflow, and wherein the reconfigurable bio-processing workflow is representative of an arrangement of one or more of the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors to perform the at least one bio-processing operation; and
a data repository comprising a listing of the one or more bio-processing units, the one or more process supporting devices, the one or more sensors, one or more process steps, one or more types of bio-processing workflows, or combinations thereof; and
one or more flexible fluid coupling tubes configured to facilitate fluid communication between the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors.

### Claim 2 (depends on 1)

The bio-processing system of claim 1, wherein the one or more bio-processing units further comprise a wave rocker, a cell banking unit, a cell harvesting unit, a chromatography unit, a protein concentration unit, a sterile filtration unit, a virus removal unit, a product holding unit, a buffer preparation unit, a media preparation unit, a buffer holding unit, a media holding unit, or combinations thereof, wherein the one or more process supporting devices comprise a pump, a weighing scale, a flow restriction clamp, a temperature management device, or combinations thereof, and wherein the one or more sensors comprise a pressure sensor, a temperature sensor, a pH sensor, a conductivity sensor, a glucose sensor, a biomass sensor, a cell viability sensor, an oxygen sensor, a carbon-dioxide sensor, an ultraviolet sensor, a flow sensor, a foam sensor, or combinations thereof.

### Claim 3 (depends on 1)

The bio-processing system of claim 1, wherein at least one of the one or more sensors is disposed along one or more of the disposable fluid coupling tubes.

### Claim 4 (depends on 1)

The bio-processing system of claim 1, wherein the one or more sensors are disposed within at least one of the one or more bio-processing units and the one or more process supporting devices.

### Claim 5 (depends on 1)

The bio-processing system of claim 1, wherein the bio-processing controller comprises a master wireless communication unit configured to communicate at least one of control commands and data between the bio-processing workflow controller and the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors.

### Claim 6 (depends on 1)

The bio-processing system of claim 1, wherein the bio-processing workflow controller further comprises:
a display unit.

### Claim 7 (depends on 6)

The bio-processing system of claim 6, wherein the processor is configured to:
generate a workflow configuration user interface using the listing, wherein the workflow configuration user interface comprises controls configured to aid in customizing the arrangement of one or more of the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors;
visualize the workflow configuration user interface on the display unit; and
receive customization inputs via the workflow configuration user interface to customize the arrangement of one or more of the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors; and
create the reconfigurable bio-processing workflow based on the customization inputs.

### Claim 8 (depends on 1)

The bio-processing system of claim 1, further comprising a smart switching device operatively coupled to at least one of the one or more bio-processing units and the one or more process supporting devices, wherein the smart switching device is configured to selectively control supply of power to the at least one of the one or more bio-processing units and the one or more process supporting devices.

### Claim 9 (depends on 8)

The bio-processing system of claim 8, wherein the smart switching device is configured to selectively control the supply of power to at least one of the one or more bio-processing units and the one or more process supporting devices based on a current signature corresponding to the one or more bio-processing units and the one or more process supporting devices.

### Claim 10 (depends on 8)

The bio-processing system of claim 8, wherein the processor is further configured to:
monitor one or more process parameters corresponding to at least one of the one or more bio-processing units, the one or more process supporting devices, and the one or more sensors;
transmit a control command to the smart switching device; and
control the supply of power to at least one of the one or more bio-processing units and the one or more process supporting devices based on the control command.
