Automated Cell Processing Unit for Contamination Reduction
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Solution Overview
Problem
Current cell and gene therapy manufacturing processes are complex, labor-intensive, and prone to contamination due to the need for manual handling and transfer of cells between multiple devices, lacking compact, automated closed systems for unit operations.
Innovation Solution
A compact, automated cell processing unit with a cell processing platform and container system that allows for multiple unit operations within a single device, featuring a compressible container with sterile connectors for aseptic connections, reducing the need for pumps and minimizing cell transfers, and utilizing a drive mechanism for rotational and compression actions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual handling and transfer of cells between multiple devices is used, then flexibility in performing different unit operations is maintained, but contamination risk increases and labor intensity increases
Solution Approach 1:
The patent combines multiple separate cell processing devices into a single integrated cell processing unit with a unified housing that contains multiple processing chambers. This merging eliminates the need for manual cell transfers between devices, thereby reducing contamination risk while maintaining the capability to perform multiple unit operations within one integrated system.
Solution Approach 2:
The integrated cell processing unit is designed with multiple processing chambers that can perform different unit operations (e.g., cell culture, washing, concentration) within a single device. This multi-functional design allows the system to maintain operational flexibility while eliminating the need for multiple separate devices and manual transfers.
2Reliability
If multiple separate devices are used for different unit operations, then specialized processing for each operation is achieved, but the number of transfers and contamination opportunities increases
Solution Approach 1:
The patent integrates multiple specialized processing chambers into one unified device, allowing cells to be processed through different unit operations without being transferred to separate devices. This eliminates manual handling steps and reduces contamination opportunities while maintaining specialized processing capabilities for each unit operation.
3Ease of manufacture
If traditional cell culture devices (flasks, bottles) are used, then cell culture is possible, but sterile additions and transfers require complex contamination prevention measures
Solution Approach 1:
The patent extracts the sterility maintenance function from complex external contamination prevention measures (such as laminar flow hoods and sterile technique requirements) and integrates it into the device design itself through sealed chambers and closed systems. This allows traditional simple device structures to maintain high sterility standards without requiring complex external contamination prevention infrastructure.
4Reliability
If scale-up of cells in culture is achieved without transfer into larger devices, then contamination risk is reduced, but the container must accommodate variable cell volumes
Solution Approach 1:
The patent employs a compressible bellows structure for the container walls that can dynamically adjust their volume. This dynamic design allows the container to expand and contract according to the cell culture volume requirements at different stages, enabling scale-up within the same sealed chamber without transferring cells to larger devices, thereby maintaining sterility while accommodating variable volumes.
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
This solution enables flexible, cost-effective, and contamination-reduced multistep cell processing, enhancing scalability and reproducibility in cell and gene therapy manufacturing by maintaining an aseptic environment without the need for laminar flow cabinets, thus improving the efficiency and robustness of clinical-grade therapeutic production.
Implementation Method 1
an actuator configured and arranged to exert a force on a container mounted into the cell processing platform so as to expel the contents from the container
Implementation Method 2
The cell processing container comprises at least one sterile connector end configured to operatively couple with a further sterile connector end so as to form a sterile connector
Data Source
AI summary
The disclosure relates to systems, devices and methods for at least one of cell and gene therapy manufacture. In some embodiments, a cell processing unit is provided and comprises a housing defining an enclosure into which a cell processing platform can be mounted, a platform mounting bracket within the housing and configured and arranged to receive and retain a cell processing platform, a drive apparatus configured and arranged to operatively engage and act upon a cell processing platform so as to move same with respect to the platform mounting bracket, and an actuator configured and arranged to exert a force on a container mounted into the cell processing platform so as to expel a contents from the container.