Closed-Loop Bedside Cell Purification for Target Cell Enrichment
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Solution Overview
Problem
Current methods for autologous cell and gene therapy (ACGT) manufacturing are cumbersome, expensive, and lack the ability to enrich specific cell populations, especially when conducted in centralized facilities, and bringing the process bedside poses significant challenges including safety and efficiency.
Innovation Solution
A patient-connected, closed-loop system for cell purification that includes an inlet conduit, apheresis module, targeting reagent, cell purification module, mixing chamber, collection chamber, detector, and processor, allowing for continuous-flow purification and delivery of purified cells directly to the patient without manual intervention.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If centralized manufacturing facilities are used for ACGT production, then regulatory compliance and testing requirements are met, but the process becomes cumbersome, expensive, and loses the ability to enrich specific cell populations
Solution Approach 1:
The system segments the cell therapy manufacturing process into modular components: apheresis module for blood collection, cell separation module with mixing chamber for cell enrichment, and return module for delivering purified cells. Each module performs a specific function, allowing the complex manufacturing process to be broken down into manageable, regulated steps that can be performed at the bedside
Solution Approach 2:
The closed-loop system serves multiple functions: it collects blood via apheresis, separates and enriches specific cell populations using magnetic targeting, maintains sterile closed-loop conditions, and returns purified cells to the patient. This multi-functional system replaces the need for separate centralized manufacturing steps while maintaining regulatory compliance
2Manufacturing precision
If cell purification is performed in centralized facilities, then specific cell populations can be enriched, but the handling requirements and costs increase significantly
Solution Approach 1:
The system uses magnetic particles as intermediaries to enable cell separation. Targeting reagents coated with magnetic particles are introduced into the blood sample, bind to specific cell populations, and allow magnetic separation in the cell separation module. This intermediary approach enables precise cell enrichment without requiring complex manual handling or specialized centralized facility equipment
Solution Approach 2:
The system replaces manual cell separation techniques with automated magnetic separation. The magnetic targeting module uses magnetic fields to separate targeted cells from blood components automatically, eliminating the need for manual centrifugation, filtration, or other labor-intensive separation methods that increase handling complexity
3Productivity
If the process is brought to the bedside in a patient-connected manner, then cost and safety benefits are achieved, but the ability to enrich specific cell populations is limited
Solution Approach 1:
The system nests multiple functions within a compact bedside device: the apheresis module, cell separation module with mixing chamber, magnetic targeting components, and return module are integrated into a single patient-connected system. This nested design enables complex cell enrichment capabilities in a space-efficient configuration that can be deployed at the bedside
Solution Approach 2:
The system changes the parameters of cell separation by using magnetic field strength, particle concentration, and flow rate adjustments to optimize enrichment of specific cell populations. The mixing chamber allows controlled incubation time and temperature, enabling precise manipulation of cell properties to achieve desired enrichment levels while maintaining bedside operation
4Adaptability or versatility
If manual intervention is required for cell purification, then flexibility in processing is maintained, but safety risks and operational complexity increase
Solution Approach 1:
The system performs self-service through automated closed-loop operation. The processor controls the apheresis module, cell separation module, and return module sequentially without manual intervention. The system automatically monitors and adjusts parameters, maintains sterile barriers, and manages the entire cell purification and return process, eliminating safety risks associated with manual handling while maintaining processing flexibility through programmable control
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
Enables efficient, safe, and cost-effective purification of target cells at the bedside, enhancing therapeutic benefit by enriching specific cell populations and allowing for real-time customization and delivery.
Implementation Method 1
separating the target cells from the blood sample or fraction thereof
Implementation Method 2
mixing the blood sample, the targeting reagent, and the buffer solution
Data Source
AI summary
Provided herein are bedside, parenterally patient connected, closed-loop and complete systems and methods for cell purification.