Cell Processing System with Post-Separation Count Control

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Solution Overview

Problem

Conventional biological fluid processing methods face challenges in accurately determining cell concentration in product containers due to uncertainties related to large source container volumes and multiple source containers, leading to inconsistencies in achieving the desired final cell concentration.

Innovation Solution

A cell processing system that includes a processor connected to a source container and wash media containers, featuring a separator that separates biological fluid into streams, pauses processing to determine a measured cell count in the product container, and adds fluid from wash media containers based on this count to achieve the desired cell concentration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the operator samples the biological fluid from large source containers to determine starting cell concentration, then the processing can be initiated, but the cell count from the sample may not be fully representative of the cell concentration in all regions of the source bag, leading to uncertainty in the final cell concentration

Engineering Contradiction:

Improveability to initiate processingVSAvoidaccuracy of cell concentration determination

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The system performs preliminary separation of the biological fluid into cell-containing stream and cell-free stream before final product collection. This allows the operator to know the actual cell concentration in the product container before completing the process, eliminating the need to rely on preliminary sampling from large source containers.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system implements feedback by measuring the cell count in the product container during or after separation and using this information to control the processing. The controller adjusts the process based on measured cell concentration, ensuring the desired final concentration is achieved regardless of initial source container variability.

Inventive Principle:

Principle #23Feedback

2Productivity

If the operator assumes full recovery or a particular recovery percentage of cells during processing, then the desired volume in the product bag can be calculated, but the assumptions made regarding the effect of processing on the initial number of cells increase the uncertainty of the calculation

Engineering Contradiction:

Improveability to calculate required volumeVSAvoidaccuracy of final cell concentration prediction

Core Design Contradiction:

ProductivityVSMeasurement precision

Solution Approach 1:

The system measures the actual cell count in the product container and uses this feedback to determine the exact volume needed to achieve the desired final concentration. This eliminates reliance on assumed recovery percentages and provides accurate prediction of final cell concentration.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system replaces the mechanical assumption-based calculation method with an automated measurement and control system. The controller automatically calculates and adjusts the volume based on measured cell counts, substituting operator assumptions with precise instrumental measurement and automated control.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Quantity of substance

If multiple source bags are used to process biological fluid, then the total number of cells can be increased, but the effects of sampling variations between the bags contribute to further uncertainty in the initial cell count

Engineering Contradiction:

Improvetotal number of cells processedVSAvoidaccuracy of initial cell count determination

Core Design Contradiction:

Quantity of substanceVSMeasurement precision

Solution Approach 1:

The system merges multiple source bags into a single processing stream and separates the combined fluid through the separation device. By processing all bags together and measuring the cell count in the final product container, the system eliminates sampling variations between individual bags and achieves accurate cell concentration determination for the total cell population.

Inventive Principle:

Principle #5Merging (Combining)

4Ease of manufacture

If the operator selects a desired volume in the product bag based on calculated cell concentration, then the processing can be configured, but the final volume selected will likely result in a cell concentration that differs from the desired concentration

Engineering Contradiction:

Improveability to configure processingVSAvoidaccuracy of final cell concentration

Core Design Contradiction:

Ease of manufactureVSManufacturing precision

Solution Approach 1:

The system measures the actual cell concentration in the product container and uses this feedback to control the final volume adjustment. The controller adds or removes fluid based on measured cell count to achieve the desired final concentration, ensuring manufacturing precision regardless of initial configuration assumptions.

Inventive Principle:

Principle #23Feedback

Solution Approach 2:

The system makes the final product concentration dynamic rather than static. Instead of fixing the volume based on preliminary calculations, the system adjusts the volume dynamically based on measured cell counts, allowing the process to adapt and achieve the desired precision.

Inventive Principle:

Principle #15Dynamics

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

This approach reduces uncertainty in cell concentration by eliminating the need for representative sampling from source containers and minimizing assumptions about cell loss during processing, resulting in a more accurate calculation of the volume required to achieve the desired final cell concentration in the product container.

Implementation Method 1

Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation.

Methodology Applied

Scientific EffectCentrifugal separation: Centrifugal Separation

Implementation Method 2

Separation devices may separate the biological fluid based on centrifugal separation and/or, as described below, membrane separation.

Methodology Applied

Scientific EffectMembrane separation: Semipermeable Membrane

Data Source

PatentUS10221385B2Cell processing system and method with post-separation cell count control

Publication Date: 2019.03.05 FENWAL INC

AI summary

A cell processing system includes a processor connectable to a source container filled with a biological fluid and one or more wash media containers. The processor includes a separator connectable to the source container and a product container, the separator configured to separate the biological fluid from the source container into at least two streams. In addition, a controller is coupled to the processor and configured to: cause the separator to separate the biological fluid into at least two streams, direct one of the at least two streams into the product container, subsequently pause processing of the biological fluid, after pausing, determine a measured cell count in the product container, and add fluid to the product container from the wash media containers as a function of the measured cell count in the product container while the product container is connected to the wash media containers.