Automated Cell Processing Enclosure for Sterile Multi-Batch QC
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Solution Overview
Problem
Current methods for producing stem cells for regenerative medicine are labor-intensive, inefficient, and expensive, limiting their widespread use due to the need for clean room operation, processing one cell line at a time, and lack of full automation for quality control tests.
Innovation Solution
An automated system for processing biological samples that maintains sterility without a clean room, allows multiple batches to be processed simultaneously, performs quality control tests, and integrates analytical capabilities, all without human intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If current manual methods are used for stem cell processing, then quality control can be performed, but the process is labor-intensive and can only process one cell line at a time
Solution Approach 1:
The system employs automated robotic modules that perform cell processing operations autonomously without human intervention. The robotic modules can autonomously navigate, manipulate cell culture vessels, perform media changes, and conduct quality control tests, enabling the system to serve itself and eliminating the need for manual labor in routine operations.
Solution Approach 2:
The processing system is divided into multiple independent robotic modules, each capable of performing specific functions such as media delivery, cell manipulation, and quality control. This segmentation allows parallel processing of multiple cell lines simultaneously, as each module can operate independently on different samples at the same time.
2Reliability
If manual processing methods are used, then flexibility in handling different cell lines is maintained, but cross-contamination risk increases and sterility cannot be ensured without clean room operation
Solution Approach 1:
The system utilizes sealed flexible membranes and barriers that create sterile boundaries between different cell processing areas. These flexible seals allow the robotic modules to access and manipulate cell culture vessels while maintaining sterility, eliminating the need for clean room environments. The membranes can be easily replaced and sterilized between runs.
Solution Approach 2:
The robotic modules act as intermediaries between the external environment and the sterile cell processing environment. The robots perform all operations within the sterile chamber without human hands entering, thereby preventing contamination. The robotic arms are equipped with sterilizable tools and operate in a controlled atmosphere that maintains sterility.
3Productivity
If automated systems are introduced to increase productivity, then processing speed improves, but system complexity and cost increase
Solution Approach 1:
The robotic modules are designed with multi-functionality, capable of performing multiple operations including media delivery, cell manipulation, quality control testing, and vessel handling. This universality reduces the overall system complexity compared to having separate specialized machines for each function, while still enabling high-throughput parallel processing of multiple cell lines.
4Measurement precision
If quality control tests are performed manually, then detailed analysis can be conducted, but the process becomes more time-consuming and labor-intensive
Solution Approach 1:
Manual quality control operations are replaced with automated robotic systems that perform sampling, testing, and analysis. The robotic modules can conduct multiple quality control tests in parallel using automated liquid handling and detection systems, maintaining measurement precision while dramatically reducing the time required compared to manual procedures.
Data Source
AI summary
A system for automated processing of a plurality of batches, each batch being derived from one biological sample, the system comprising an enclosure which can be closed and sterilized, each batch of the plurality of batches comprising one or more cell processing container; a plurality of reagent containers for holding reagents within the enclosure; at least one reagent dispenser within the enclosure for dispensing reagents during said automated processing; a quality control system within the enclosure for analyzing at least one characteristic of a batch during said automated processing; a harvester within the enclosure for harvesting batches; a robotic system within the enclosure, configured for transporting cell processing containers, decapping or otherwise opening cell processing containers, pipetting reagents or liquids from cell processing containers, and aspirating liquids from cell processing containers, during said automated processing; a tracker for electronically tracking the plurality of batches after its introduction to the enclosure; and a control unit (CU) communicatively coupled to the at least one reagent dispenser, the quality control system, the harvester, the robotic system and the tracker for controlling said automatic processing of said batches.