Robotic Cell Processing Workcell for Sterile Modular Throughput
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Solution Overview
Problem
Conventional cell product manufacturing processes are cumbersome, costly, and prone to human error, lacking end-to-end process flexibility, scalability, and sterility, especially in automated systems.
Innovation Solution
A system comprising a robot and instruments within a workcell that processes cell products in a cartridge, enabling automated, flexible, and scalable cell processing with improved sterility and reduced risk of contamination, using modules such as bioreactors, sorting, and electroporation units.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If automated cell processing systems are implemented, then productivity and repeatability are improved, but device complexity increases
Solution Approach 1:
The automated cell processing system is divided into discrete functional modules (e.g., cell harvesting module, washing module, freezing module, storage module) that can be independently configured and operated. Each module performs a specific cell processing function, allowing the system to achieve high productivity through automation while managing complexity through modular architecture.
Solution Approach 2:
The system is designed with multi-functional instruments and modules that can perform multiple cell processing operations. For example, a single instrument may be capable of both washing and freezing cells, or the system can be configured to handle different cell types and processing protocols, thereby improving productivity without proportionally increasing device complexity.
2Reliability
If manual operations are used in biosafety cabinets and clean rooms, then sterility is maintained, but labor costs and process duration increase
Solution Approach 1:
The system performs preliminary sterilization and preparation actions automatically before cell processing begins. Sterile barriers and closed-system configurations are established in advance, allowing automated operations to proceed without compromising sterility while reducing the time required for manual sterile technique operations.
Solution Approach 2:
The automated system maintains sterility through self-contained closed architectures and automated sterile barrier management. The system independently manages sterile connections, fluid transfers, and contamination prevention without requiring continuous manual intervention, thereby maintaining high sterility standards while significantly reducing process duration and labor requirements.
3Ease of operation
If pre-configured instrumentation and tubing sets are used, then ease of operation is improved, but adaptability and process flexibility are reduced
Solution Approach 1:
The system employs dynamic, reconfigurable connections and modular module arrangements that allow the instrumentation and tubing configurations to be changed based on the specific cell processing protocol required. This enables the system to maintain ease of operation through automated control while achieving adaptability through programmable reconfiguration of the processing pathway.
Solution Approach 2:
The system adds the dimension of programmable control and software-based protocol management to the physical instrumentation. This allows pre-configured instruments to be dynamically reconfigured through software parameters and control sequences, maintaining operational simplicity while enabling diverse cell processing applications without requiring physical reconfiguration of the entire system.
4Manufacturing precision
If skilled laboratory technicians perform manual operations, then manufacturing precision is maintained, but labor costs and operational complexity increase
Solution Approach 1:
The automated system incorporates sensors, monitors, and control systems that provide real-time feedback on cell processing parameters (e.g., temperature, pressure, flow rates, cell viability). This feedback mechanism maintains manufacturing precision by automatically adjusting parameters to match optimal ranges, replacing the need for skilled technician judgment while reducing operational complexity through automated control.
Solution Approach 2:
The system replaces manual mechanical operations performed by technicians with automated robotic manipulators, pumps, and controlled fluid handling systems. This substitution maintains or improves precision through consistent automated execution of protocols while reducing the need for skilled manual operations and simplifying the operational interface through software-based control.
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.