Portable controlled micro-environment device for modular bio-processing
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Solution Overview
Problem
Current cellular therapy processes require costly clean room environments and infrastructure for processing biological materials, limiting flexibility, mobility, and increasing costs, especially in time-sensitive applications like transplants.
Innovation Solution
A portable, modular, and traceable microenvironment system with interconnected containment modules that ensures non-contaminating mechanical or fluid communication, reduces process errors, and manages sample identification and data tracking to maintain biological purity and efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If cellular therapy processes are conducted in traditional clean room environments, then biological purity is maintained, but cost and infrastructure requirements increase significantly
Solution Approach 1:
The system divides the cellular therapy process into separate modular containment units, each performing a specific function (e.g., processing, storage, transfer). These self-contained modules maintain biological purity independently while simplifying overall infrastructure needs, as each module is a discrete, manageable unit rather than requiring a complete clean room environment.
Solution Approach 2:
The invention extracts the essential clean room function (maintaining biological purity) from the expensive clean room infrastructure and concentrates it into portable containment modules. This allows the critical purity-maintaining function to be separated from the costly facility requirements, enabling the same function to be achieved in simpler, more affordable settings.
2Reliability
If traditional clean room infrastructure is used for cellular processing, then biological materials are protected from contamination, but mobility and flexibility are reduced
Solution Approach 1:
The system segments the contamination protection function into portable containment modules that can be moved and repositioned as needed. Each module maintains its protective barrier independently, allowing the system to be deployed in various locations without requiring a fixed clean room facility, thus achieving both contamination protection and mobility.
Solution Approach 2:
The invention extracts the contamination protection capability from the fixed clean room structure and embeds it within mobile containment units. This allows the protective function to be transported and deployed wherever needed, providing adaptability while maintaining the same level of biological material protection.
3Adaptability or versatility
If modular containment units are used for cellular processing, then mobility and flexibility improve, but ensuring non-contaminating connections between modules becomes more challenging
Solution Approach 1:
The system employs sterile connectors and transfer mechanisms as intermediaries between containment modules. These specialized connection components are designed to maintain sterility during module interfacing, allowing mobile operation while preventing contamination at connection points through dedicated sterile barriers and controlled transfer protocols.
4Device complexity
If portable containment modules are implemented, then cost and infrastructure requirements are reduced, but traceability and sample identification management become more complex
Solution Approach 1:
The system incorporates tracking mechanisms that provide continuous feedback on sample location and status across the modular units. This information feedback system ensures that even as samples move between portable modules, their identity and location are continuously monitored and recorded, preventing loss of traceability information while maintaining the benefits of mobile operation.
Data Source
AI summary
Apparatus and associated methods relate to an adaptable microenvironment for cellular and biological processing in a traceable, transportable unit. In an illustrative example, an apparatus consists of one or more portable cell tissue containment modules that may be removably interconnected to perform a processing step and/or transfer the stored medium to another module. Associated apparatus and methods are proposed to ensure non-contaminating mechanical or fluid communication between a plurality of modules or between a module and peripheral equipment, to limit process errors such as steps performed out of order, and to intrinsically manage identification of tissue samples with accompanying process data in a manner that decreases risk of mislabeling or otherwise mishandling a sample at all stages of the production and treatment process.