Robotic Cell Processing Workcell for Sterile Flexible Manufacturing
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Solution Overview
Problem
Conventional 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 comprising a cartridge with multiple modules and a robot for automated cell processing, enabling sterility, reduced labor costs, and improved flexibility, scalability, and reliability by moving the cartridge between instruments within a workcell.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional 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 employs self-service automation where robotic instruments autonomously perform cell processing operations without human intervention. The automated instruments handle reagent preparation, cell manipulation, and processing steps independently, eliminating the need for skilled technicians to manually operate in clean rooms while maintaining sterility through closed-system design.
Solution Approach 2:
Manual mechanical operations performed by technicians in biosafety cabinets are replaced with automated robotic systems. The patent substitutes human hands and manual manipulation with robotic instruments that can precisely handle cells and reagents, reducing operational complexity while maintaining or improving sterility through programmable, contamination-free operations.
2Adaptability or versatility
If multiple manual reagent preparation and instrument manipulation steps are employed, then process flexibility can be achieved, but process duration extends to several days or weeks
Solution Approach 1:
The automated system enables continuous processing where cell therapy manufacturing operations proceed without interruption. Multiple processing steps are executed in sequence without the delays inherent in manual operations, as robotic instruments can immediately transition between tasks. This continuous automation reduces process duration from days or weeks to hours while maintaining flexibility through programmable protocols.
Solution Approach 2:
The system performs preliminary preparation of reagents and processing parameters before cell therapy manufacturing begins. Automated instruments pre-configure reagent volumes, temperatures, and processing conditions in advance, eliminating the need for time-consuming manual setup during the actual cell processing, thus reducing overall process duration while maintaining adaptability.
3Extent of automation
If pre-configured instrumentation and tubing sets are used in automated systems, then automation is achieved, but operational flexibility is limited
Solution Approach 1:
The system employs dynamic, reconfigurable instrumentation rather than fixed pre-configured setups. Robotic instruments can be programmatically adjusted to perform different cell processing operations, and tubing connections can be dynamically established or modified based on the specific manufacturing protocol required. This dynamic adaptability maintains full automation while enabling flexibility across various cell therapy processes.
4Reliability
If skilled laboratory technicians perform manual operations, then process robustness can be maintained, but labor costs and risk of human error increase
Solution Approach 1:
The automated system incorporates feedback mechanisms where sensors and controllers continuously monitor processing conditions and automatically adjust parameters to maintain process robustness. This closed-loop control eliminates the need for skilled technicians to manually monitor and adjust operations, reducing labor costs while maintaining or improving process reliability through consistent, error-free automated execution.
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.


