Cell Processing Cartridge Automation for Sterile Flexible Throughput
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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 cell processing using a cartridge that moves between instruments within an automated workcell, incorporating modules for bioreactor, cell selection, and centrifugal elutriation, with a robot and processor for automated control, enabling flexible and scalable processing in a smaller, sterile environment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated cell processing systems are implemented, then productivity and reliability are improved, but device complexity increases
Solution Approach 1:
The automated cell processing system is divided into separate functional modules including a cartridge with multiple chambers (reaction chamber, washing chamber, elutriation chamber), a robot for cartridge manipulation, and various instruments for different processing steps. Each module performs a specific function, allowing the system to achieve high productivity through modular automation while managing complexity through functional segmentation.
2Object-affected harmful factors
If cleanroom facilities and manual operations are used, then sterility is maintained, but manufacturing cost increases
Solution Approach 1:
The cartridge system is designed to be self-contained and self-sterilizing. The cartridge includes integrated sterilization features and maintains sterility through its closed design, eliminating the need for expensive cleanroom facilities. The system performs its own sterilization function, reducing external infrastructure requirements and manufacturing costs while maintaining contamination control.
3Ease of operation
If pre-configured instrumentation and tubing sets are used, then ease of operation is improved, but adaptability decreases
Solution Approach 1:
The system employs a dynamic, reconfigurable cartridge design where chambers and fluid pathways can be dynamically controlled through electronic valve and pump systems. The robot can manipulate the cartridge in various positions, and the fluidics system can dynamically route reagents and cell suspensions to different chambers based on the processing protocol, providing both ease of operation through automation and adaptability through reconfigurability.
4Adaptability or versatility
If manual reagent preparation and instrument manipulation steps are performed, then adaptability is maintained, but loss of time increases
Solution Approach 1:
The automated system enables continuous processing through integrated fluidics that continuously pump reagents and cell suspensions through the cartridge chambers without manual intervention. The robot continuously manipulates the cartridge between instruments, and multiple processing steps (mixing, incubation, washing, elutriation) occur in sequence without interruption, eliminating the time losses associated with manual setup and transitions while maintaining protocol flexibility.
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.