Closed Cell Processing Cartridge for Sterile High-Purity Separation
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for processing human cells for therapeutic use require significant infrastructure and manual handling, posing risks of contamination and complexity, and lack efficient, automated systems for high-purity cell separation and processing.
Innovation Solution
A fully automated system integrating a sample processing unit and separation unit, utilizing a magnetic separation column with a uniform flow channel and a rotating container for centrifugation, enabling efficient, sterile, and high-purity isolation of specific cells and biological materials, with minimal manual intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual cell processing and transfer methods are used, then flexibility in handling is maintained, but contamination risk increases and operational complexity increases
Solution Approach 1:
The patent integrates multiple cell processing functions (separation, purification, formulation) into a single closed system with integrated cartridges, eliminating the need for multiple separate devices and manual transfers between them. This consolidation reduces contamination risk while managing infrastructure requirements through a unified platform.
Solution Approach 2:
The patent introduces automated robotic handlers and closed-system cartridges as intermediaries between sample sources and processing devices, eliminating direct manual contact with cellular products. These intermediaries maintain sterility while simplifying operator interaction with the complex system.
2Reliability
If multiple separate devices are used for cell processing steps, then each device can be optimized for its specific function, but manual transfer between devices increases contamination risk and time loss
Solution Approach 1:
The patent combines multiple processing steps (magnetic separation, filtration, formulation) into a single integrated workflow within one device, allowing cellular products to flow continuously through connected cartridges without manual intervention. This eliminates transfer time and maintains product safety.
Solution Approach 2:
The patent implements continuous automated fluid flow through the processing system, maintaining uninterrupted processing of cellular products from input to output. This continuous operation eliminates idle time between steps and ensures constant monitoring for safety.
3Ease of operation
If automated systems are implemented, then manual handling is reduced and contamination risk decreases, but device complexity and infrastructure requirements increase
Solution Approach 1:
The patent implements self-contained cartridges with pre-loaded reagents and pre-configured separation media that require minimal setup or maintenance. The system automatically performs all processing functions without requiring operators to manually configure complex parameters or perform routine maintenance tasks.
Solution Approach 2:
The patent uses disposable single-use cartridges that are discarded after a single processing run, eliminating the need for complex cleaning, sterilization, and maintenance infrastructure. This approach reduces long-term operational complexity while maintaining high automation levels.
4Manufacturing precision
If high-purity cell separation is achieved through multiple processing steps, then cellular product quality improves, but processing complexity and infrastructure needs increase
Solution Approach 1:
The patent integrates multiple separation mechanisms (magnetic separation, size-based filtration, density-based separation) into a single multi-cartridge workflow, achieving high-purity cell isolation without requiring multiple separate processing stations. This consolidation maintains manufacturing precision while reducing infrastructure complexity.
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
The system ensures high-purity cell separation with reduced contamination risk, allowing direct use of processed cells for clinical applications, minimizing infrastructure needs and operational complexity.
Implementation Method 1
Magnetic separation is a procedure for selectively retaining magnetic materials in a chamber or column disposed in a magnetic field. A target substance, including biological materials, may be magnetically labeled by attachment to a magnetic particle by means of a specific binding partner, which is conjugated to the particle.
Implementation Method 2
a rotating container (or centrifugation chamber) having at least one sample chamber, wherein the sample processing unit is configured to provide a first processing step to a sample or to rotate the container so as to apply a centrifugal force to a sample deposited in the chamber and separate at least a first component and a second component of the deposited sample
Data Source
AI summary
The invention relates to a system, comprising: a) a sample processing unit, comprising an input port and an output port coupled to a rotating container having at least one sample chamber, the sample processing unit configured provide a first processing step to a sample or to rotate the container so as to apply a centrifugal force to a sample deposited in the chamber and separate at least a first component and a second component of the deposited sample; and b) a sample separation unit coupled to the output port of the sample processing unit, the cell separation unit comprising separation column holder, a pump and a plurality of valves configured to at least partially control fluid flow through a fluid circuitry and a separation column positioned in the holder, the separation column configured to separate labeled and unlabeled components of sample flowed through the column.