Modular Cell Processing Layout for Parallel Sterile Sample Handling
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Solution Overview
Problem
Current cell therapy processing facilities are inefficient and costly due to duplication of processing units, leading to underutilization of resources, high setup and running costs, and risks of contamination, with limited scalability for processing multiple patient samples.
Innovation Solution
A scalable cell processing facility with multiple identical processing stations in discrete units, using uniquely encoded disposable containers and components to maintain sample integrity and identity, allowing parallel processing and automated workflow optimization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate and isolated processing rooms or units are used for each patient sample, then sample integrity and identity are maintained, but facility costs and space requirements increase linearly with the number of samples
Solution Approach 1:
The facility is divided into modular processing units, each capable of independently processing one patient sample while maintaining sterile separation. This segmentation allows multiple samples to be processed in parallel across different modules rather than requiring one large dedicated room per sample, thus maintaining sample integrity while reducing total space requirements through shared infrastructure.
2Reliability
If duplicated processing units are used for each patient sample, then contamination and cross-contamination are prevented, but equipment costs and operational efficiency deteriorate due to underutilization
Solution Approach 1:
Processing is segmented into discrete sterile modules that can be independently used for different patients. Each module maintains its sterile barrier, preventing cross-contamination, while the modular design allows multiple modules to operate simultaneously, improving overall equipment utilization compared to having entire processing units idle during long culture steps.
Solution Approach 2:
The modular processing units are designed to be universal and interchangeable, where any module can process any patient sample. This multi-functionality allows the system to flexibly allocate resources and maintain high utilization rates, as modules can be reassigned between patients without compromising sterility or requiring dedicated single-use configuration.
3Ease of operation
If open containers are used in laminar air flow cabinets, then material manipulation is simplified, but contamination risk increases
Solution Approach 1:
The system employs flexible sterile barriers such as laminar flow hoods with integrated sterile drape systems or flexible membrane-covered processing chambers. These thin film barriers maintain sterile separation while allowing operators to manipulate materials inside the sterile field with minimal restriction, combining the ease of open container manipulation with the protection of closed sterile systems.
Data Source
AI summary
The present invention provides improved methods, facilities and systems for parallel processing of biological cellular samples in an efficient and scalable manner. The invention enables parallel processing of biological cellular samples, such as patient samples, in a space and time efficient fashion. The methods, facilities and systems of the invention find particular utility in processing patient samples for use in cell therapy.