Direct Plasma Purification Using 4-15 μm Chromatography

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Solution Overview

Problem

Current methods for purifying target components from full plasma samples require pre-processing steps such as dilution and cryoprecipitation, which increase process time and cost, and risk clogging chromatographic units or activating plasma components.

Innovation Solution

A method involving the direct application of full, undiluted plasma to a continuous chromatographic material with channels of 4 to 15 μm diameter, using a chromatographic selection element, and performing chromatography at 30 to 39°C to recover target components without pre-processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sample dilution is performed before plasma processing, then plugging of chromatographic units is prevented, but process time increases and cost increases

Engineering Contradiction:
Improveprevention of chromatographic unit pluggingVSAvoidprocess time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent changes the physical parameters of the plasma sample by adjusting pH and temperature, and by performing ultrafiltration to concentrate the sample. These parameter changes enable direct injection of plasma without dilution, preventing chromatographic unit plugging while avoiding the time loss associated with dilution steps

Inventive Principle:
Principle #35Parameter changes

2Reliability

If sample dilution is performed before plasma processing, then chromatographic unit plugging is prevented, but process cost increases

Engineering Contradiction:
Improveprevention of chromatographic unit pluggingVSAvoidprocess cost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent employs parameter changes including pH adjustment, temperature control, and ultrafiltration concentration to prepare plasma for direct injection. This eliminates the need for dilution with expensive buffers and reduces overall process cost while maintaining reliability by preventing plugging

Inventive Principle:
Principle #35Parameter changes

3Reliability

If plasma is processed at low temperatures, then degradation of sensitive molecules is prevented, but viscosity increases causing processing difficulties

Engineering Contradiction:
Improveprevention of molecule degradationVSAvoidplasma viscosity
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent performs preliminary ultrafiltration and concentration of plasma before chromatographic analysis. This preliminary action removes excess water and concentrates the sample, which compensates for the increased viscosity at low temperatures and enables successful processing without degradation of sensitive molecules

Inventive Principle:
Principle #10Preliminary action

4Loss of time

If direct injection of undiluted plasma is performed, then process time is reduced and cost is reduced, but chromatographic unit plugging occurs

Engineering Contradiction:
Improveprocess timeVSAvoidchromatographic unit plugging
Core Design Contradiction:
Loss of timeVSReliability

Solution Approach 1:

The patent applies parameter changes including pH adjustment, temperature control, and ultrafiltration concentration to prepare undiluted plasma for direct injection. These changes modify the plasma properties to prevent plugging while maintaining the time and cost advantages of direct injection without dilution

Inventive Principle:
Principle #35Parameter changes

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 method enables efficient purification of target components from full plasma without clogging or activating plasma components, reducing process time and cost, and improving the yield and quality of the product.

Implementation Method 1

a continuous chromatographic material such as a synthetic monolith or membrane-based support for the processing of full, undiluted human plasma

Methodology Applied
Scientific EffectChromatography: Chromatography

Implementation Method 2

the chromatographic material comprising a chromatographic selection element for the target component

Methodology Applied
Scientific EffectAdsorption: Adsorption

Implementation Method 3

the continuous chromatographic material comprising channels having a diameter of 4 to 15 μm

Methodology Applied
Scientific EffectConvection: Convection

Data Source

PatentUS20250194975A1Method of purifying or removing a target component from full plasma
Publication Date: 2025.06.19 SARTORIUS BIA SEPARATIONS D O O
  • US20250194975A1 patent drawing
  • US20250194975A1 patent drawing
  • US20250194975A1 patent drawing

AI summary

The present invention relates to a method of purifying a target component from a full plasma sample. The present invention further relates to a method of removing one or more target components from a full plasma sample.