Automated Cell Processing Workcell With Robotic Cartridge Transfer
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Solution Overview
Problem
Current cell product manufacturing processes are cumbersome, expensive, and prone to human error, lacking end-to-end process flexibility, robustness, and scalability, and often require costly cleanroom facilities.
Innovation Solution
A system and method for processing cell products using a cartridge that moves between instruments within an automated workcell, incorporating modules for various cell processing operations, including bioreactor, selection, and sorting, with a robot and processor control, enabling automated, flexible, and scalable manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual operations are used in biosafety cabinets and clean rooms, then sterility can be maintained, but labor costs and operational complexity increase significantly
Solution Approach 1:
The system uses self-contained cartridges with integrated sterile barriers that maintain sterility automatically without requiring manual sterile techniques. The closed system design allows the cartridge to service itself regarding sterility maintenance throughout the processing workflow.
Solution Approach 2:
Manual mechanical operations performed by technicians in biosafety cabinets are replaced by an automated robotic system that manipulates cartridges through standardized interfaces, eliminating the need for manual sterile handling while maintaining sterility through the closed system design.
2Ease of operation
If automated systems are implemented, then labor costs and operator error risk decrease, but initial system cost and complexity increase
Solution Approach 1:
The automated system is segmented into modular components: standardized cartridges containing processing modules, a robotic manipulation system, and a control system. This segmentation allows the complexity to be distributed and managed through standardized interfaces rather than requiring a monolithic complex system.
Solution Approach 2:
The robotic system uses universal standardized interfaces and cartridge designs that can perform multiple cell processing operations through different cartridge configurations, reducing the need for specialized equipment for each operation and thereby reducing overall system complexity.
3Loss of time
If pre-configured instrumentation and tubing sets are used, then setup time is reduced, but operational flexibility and adaptability are limited
Solution Approach 1:
The system transitions from static pre-configured tubing sets to dynamic reconfigurable cartridge assemblies. Cartridges can be selectively assembled with different modules and configurations based on the specific processing requirements, allowing the system to adapt dynamically to different operations while maintaining quick setup through standardized components.
Solution Approach 2:
The system allows changes in operational parameters by swapping cartridges with different configurations rather than reconfiguring fixed instrumentation. This enables flexible adaptation to different processing needs while maintaining consistent standardized interfaces and setup procedures.
4Object-affected harmful factors
If closed system automation is implemented, then contamination risk is reduced, but process failure risk from accidental operator error increases
Solution Approach 1:
The control system incorporates feedback mechanisms that monitor cartridge handling, connection status, and processing parameters. This feedback allows the system to detect and correct potential errors automatically, preventing process failures while maintaining the closed system's contamination protection.
Solution Approach 2:
The system incorporates error prevention features built into the cartridge design and robotic handling, such as fail-safe connection mechanisms and validated processing protocols, that cushion against potential operator errors before they can cause process failure.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This approach enhances sterility, reduces costs, minimizes labor and contamination risks, improves process reliability and throughput, and allows for faster, more flexible cell product manufacturing with reduced risk of loss.
Implementation Method 1
The cartridge may comprise a magnetic-activated cell selection module
Implementation Method 2
The sorting module may comprise a fluorescence activated cell sorting (FACS) module
Implementation Method 3
The cartridge may comprise an electroporation module
Implementation Method 4
The cartridge may comprise a counterflow centrifugal elutriation (CCE) module
Data Source
AI summary
Disclosed herein are cell processing systems, devices, and methods thereof. A system for cell processing may comprise a plurality of instruments each independently configured to perform one or more cell processing operations upon a cartridge, and a robot capable of moving the cartridge between each of the plurality of instruments.