Robotic Cell Processing Cartridges for Sterile, Scalable 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 cartridge with integrated modules for cell processing operations, moved by a robot within a workcell, which includes bioreactor, CCE, MACS, FACS, and electroporation modules, enabling automated, sterile, and scalable processing with reduced labor costs and contamination risk.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If manual operations are used in biosafety cabinets and clean rooms, then cell processing can be performed with simple equipment, but the process becomes cumbersome, expensive, and prone to human error
Solution Approach 1:
The patent combines multiple cell processing functions (culture, separation, sorting, formulation) into a single integrated automated system with a robot that moves cartridges between processing stations. This merging of functions eliminates the need for separate manual operations in biosafety cabinets and clean rooms, thereby improving manufacturing efficiency while maintaining ease of manufacture through standardized modular components.
Solution Approach 2:
The automated system performs cell processing operations autonomously without requiring manual intervention. The robot automatically moves cartridges between processing stations, and the system self-manages the entire manufacturing workflow from cell culture to final product formulation, eliminating human error and improving productivity.
2Productivity
If automated systems are used for cell processing, then productivity and repeatability improve, but device complexity increases
Solution Approach 1:
The automated system is divided into discrete modular processing stations (culture station, separation station, sorting station, formulation station), each performing a specific function. The robot moves cartridges between these segmented stations, allowing the system to achieve high productivity through automation while managing device complexity through modular design that enables independent optimization and maintenance of each module.
Solution Approach 2:
The robot and processing stations are designed with universal interfaces and standardized cartridge formats that allow a single automated system to perform multiple cell processing functions. This multi-functionality enables the system to handle various cell types and processing protocols without requiring separate specialized equipment, thereby improving productivity while controlling overall system complexity.
3Extent of automation
If current automated systems with pre-configured instrumentation are used, then automation is achieved, but operational flexibility is limited and process failure risk increases
Solution Approach 1:
The system employs dynamic, reconfigurable processing protocols that can be adjusted based on specific cell therapy requirements. The robot and processing stations can adapt their operations in real-time, allowing the highly automated system to maintain operational flexibility for different cell types, processing steps, and clinical indications while preventing process failure through automated error detection and correction.
Solution Approach 2:
The automated system allows for dynamic parameter changes in processing protocols, including flow rates, pressure, temperature, and magnetic field strength, depending on the specific processing requirements. This capability enables the system to maintain high automation levels while adapting to different operational conditions and cell types, thereby preserving operational flexibility and reducing process failure risk.
4Adaptability or versatility
If manual reagent preparation and instrument manipulation steps are used, then process flexibility is maintained, but the process duration extends to several days or weeks
Solution Approach 1:
The automated system performs cell processing operations continuously without interruption, with the robot moving cartridges between processing stations in an uninterrupted sequence. This continuous operation eliminates the delays associated with manual reagent preparation and instrument manipulation, reducing manufacturing duration from days or weeks to hours while maintaining process flexibility through programmable protocols that can be adjusted for different cell therapy requirements.
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
The system achieves improved sterility, automation, lower costs, higher throughput, and process flexibility, reducing the risk of operator error and contamination while enabling faster and more reliable cell product manufacturing.
Implementation Method 1
a rotor configured to separate cells from a fluid
Implementation Method 2
a magnet configured to magnetically rotate the rotor and separate the cells from the fluid in the rotor
Implementation Method 3
a magnetic-activated cell selection 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.