Cell Processing Method Using Encoded Disposable Components
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Solution Overview
Problem
Current cell therapy processing facilities face inefficiencies and high costs due to duplication of equipment and space, leading to underutilization of resources and risks of contamination, making it challenging to process biological cellular samples in a scalable and cost-effective manner while maintaining sample integrity and identity.
Innovation Solution
A method involving uniquely encoded disposable components and a database system to track and verify the identity of patient samples and processing components, ensuring correct sequential coupling and processing instructions, while maintaining physical and identity integrity through analytical verification of biomarker signatures, and using a scalable facility design with discrete processing units to optimize workflow efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If separate and isolated processing units are used for each patient sample, then sample identity integrity and sterility are maintained, but facility costs and space requirements scale linearly with the number of samples
Solution Approach 1:
The facility is divided into shared processing zones and dedicated patient-specific enclosed modules. Each patient sample is processed in a sealed module that can be independently handled, while sharing common infrastructure (clean rooms, equipment, staff). This segmentation maintains sample integrity through physical isolation while reducing overall facility space by eliminating redundant infrastructure for each patient.
Solution Approach 2:
Patient-specific processing modules are nested within shared clean room environments. The enclosed patient-specific containers and processing chambers are placed inside the larger shared facility infrastructure, allowing multiple patient samples to be processed simultaneously in a compact arrangement that shares common services and space.
2Reliability
If duplicated processing units are used for each patient sample, then contamination and cross-contamination risks are minimized, but equipment and resource utilization efficiency decreases
Solution Approach 1:
Processing is segmented into patient-specific sealed modules that prevent cross-contamination, while the supporting infrastructure (equipment, clean rooms, personnel) is shared across multiple patients. This allows high resource utilization through sharing while maintaining contamination prevention through modular isolation.
Solution Approach 2:
Sealed transfer interfaces and automated handling systems act as intermediaries between patient-specific modules and shared processing equipment. These intermediaries enable contamination-free transfer of samples and materials while allowing efficient sharing of expensive equipment and facilities across multiple patients.
3Reliability
If open containers are used in clean rooms for sample manipulation, then sterility can be maintained with proper environmental controls, but risk of contamination and sample loss remains
Solution Approach 1:
Samples are manipulated within flexible sealed containers and thin-film sealed chambers that maintain sterility through physical barriers rather than relying solely on environmental controls. These sealed containers can be manipulated like open systems while preventing contamination, and can be securely tracked and accounted for throughout the process.
Solution Approach 2:
Unique identifiers on containers and samples enable real-time tracking and verification systems. The system provides feedback on sample location, container integrity, and processing status, allowing immediate detection and correction of potential contamination or loss events while maintaining sterility through controlled access protocols.
Data Source
AI summary
The present invention provides improved methods for maintaining the physical separation and identity integrity of a biological cellular sample from a patient during processing. The invention enables parallel processing of biological cellular samples, such as patient samples, in a space and time efficient fashion. The methods of the invention find particular utility in processing patient samples for use in cell therapy.