Robotic Cartridge Cell Processing Workcell for Sterile Manufacturing
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Solution Overview
Problem
Conventional cell product manufacturing processes are cumbersome, expensive, and prone to human error due to reliance on manual operations in biosafety cabinets and clean rooms, lacking end-to-end process flexibility, robustness, and scalability, and current automated systems are limited by inflexible instrumentation and high contamination risk.
Innovation Solution
A system comprising a workcell with a robot and multiple instruments that can process cell products in a cartridge, enabling automated, sterile, and flexible manufacturing with reduced footprint, using a cartridge with integrated modules for various processing steps, and a fluid connector for sterile liquid transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual operations are used in biosafety cabinets and clean rooms, then cell processing can be performed, but the process becomes cumbersome, expensive, and prone to human error
Solution Approach 1:
The system enables self-service automation where the automated instrument performs cell processing operations independently without requiring manual intervention in biosafety cabinets. The robot autonomously manipulates cartridges and reagents, eliminating human error while maintaining process reliability through programmed protocols and automated control systems.
Solution Approach 2:
Manual mechanical operations performed by technicians in biosafety cabinets are replaced by an automated robotic system with specialized end effectors. The robot mechanically manipulates cartridges, reagents, and instruments through programmed sequences, substituting human hands and reducing human error while improving process reliability and consistency.
2Adaptability or versatility
If automated systems are implemented, then labor costs and contamination risk are reduced, but current automated systems lack process flexibility and have high contamination risk due to inflexible instrumentation
Solution Approach 1:
The automated instrument is designed with universal multi-functionality to perform diverse cell processing operations including cell culture, harvesting, washing, and formulation. The system uses interchangeable end effectors and modular cartridges that can be configured for different protocols, providing process flexibility without requiring separate specialized instruments for each operation.
Solution Approach 2:
The system incorporates dynamic reconfigurability where the robot can adapt its end effectors and processing protocols in real-time based on the specific cell product and process requirements. The instrument dynamically adjusts parameters such as agitation speed, temperature, and processing time to optimize each step, providing flexibility while maintaining automated control.
3Productivity
If multiple manual reagent preparation and instrument manipulation steps are employed, then cell processing can be completed, but the process duration extends to several days or weeks
Solution Approach 1:
The automated system implements continuous processing where the robot operates without interruption to perform sequential operations including cell culture, harvesting, washing, and formulation. Multiple cartridges can be processed in parallel, and the system continuously agitates, mixes, and transfers materials without the delays associated with manual setup and intervention between steps.
Solution Approach 2:
The system performs preliminary preparation of reagents and cartridges in advance, with pre-filled cartridges and pre-prepared media ready for immediate use. The robot is pre-programmed with optimized protocols that eliminate setup time between operations, allowing the process to begin immediately and proceed through all steps without interruption or delays.
4Ease of manufacture
If skilled laboratory technicians and sterile enclosures are used, then regulated manufacturing can be performed, but the costs of facilities and labor increase significantly
Solution Approach 1:
The automated instrument performs all cell processing operations independently without requiring skilled laboratory technicians to manually manipulate samples or reagents. The system self-manages cartridge handling, reagent delivery, and process monitoring, eliminating the need for expensive clean room facilities and highly trained personnel while maintaining GMP compliance through automated documentation and control.
Solution Approach 2:
The system uses disposable single-use cartridges and reagent containers that eliminate the need for expensive reusable glassware and extensive cleaning validation. These disposable components are pre-sterilized and can be discarded after single use, significantly reducing facility cleaning costs, water consumption, and the need for highly trained technicians to perform complex sterilization procedures.
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.