Hepatocyte Pooling Method Reducing Cryopreservation Stress

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Solution Overview

Problem

Existing methods for pooling and cryopreserving hepatocytes from multiple donors subject cells to physical and chemical stress, leading to cell loss and reduced viability due to density gradient centrifugation and the use of toxic cryopreservative solutions like DMSO.

Innovation Solution

A method involving thawing hepatocytes from multiple sources, pooling them in a preservation solution to dilute DMSO, centrifuging without a density gradient to pellet viable and non-viable cells, and then cryopreserving them in a controlled manner to minimize stress, followed by density gradient fractionation before use to separate viable cells.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If density gradient centrifugation is used to separate viable cells during pooling, then cell separation precision is improved, but cell loss increases and viability decreases due to mechanical stress

Engineering Contradiction:
Improvecell separation precisionVSAvoidcell viability
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent performs density gradient centrifugation after the final thaw step, which is the preliminary action taken immediately before experimental use. This timing allows cells to be separated just in time, minimizing the duration of stress exposure while still achieving the necessary separation precision for obtaining viable cells.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent eliminates the density gradient centrifugation step from the pooling process itself, rushing through the pooling without this stress-inducing separation. Instead, only simple centrifugation is performed during pooling, and the density gradient step is skipped entirely during this phase, reserving it only for the final preparation before use.

Inventive Principle:
Principle #21Skipping (Rushing through)

2Measurement precision

If hepatocytes are pooled from multiple donors to represent population diversity, then measurement accuracy of liver function is improved, but process complexity increases

Engineering Contradiction:
Improveliver function measurement accuracyVSAvoidpooling process complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent merges multiple donor hepatocyte samples into a single pooled sample using a simplified protocol. By combining cells from multiple donors in one standardized process without intermediate density gradient separations, the method achieves population-representative measurements while reducing overall process complexity compared to handling each donor separately.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent changes the centrifugation parameters during pooling to optimize for cell recovery rather than separation. By using lower centrifugal forces and simpler protocols tailored to the specific properties of cryopreserved hepatocytes, the method simplifies the pooling process while maintaining the ability to pool diverse donor samples effectively.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If cryopreservative solutions containing DMSO are used throughout the pooling process, then cell preservation is improved, but cell toxicity increases leading to cell death

Engineering Contradiction:
Improvecell preservationVSAvoidDMSO toxicity
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent extracts or removes the density gradient centrifugation step from the pooling process, eliminating the source of mechanical stress that compounds the chemical stress from DMSO. This removal reduces the cumulative harmful effects on cells while maintaining cryopreservation effectiveness.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies density gradient centrifugation only partially - specifically, only after the final thaw and immediately before experimental use, rather than during the pooling process itself. This partial application provides just enough separation precision when needed while avoiding excessive stress exposure that would compound DMSO toxicity.

Inventive Principle:
Principle #16Partial or excessive action

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 increases the recovery of viable hepatocytes, reducing exposure to mechanical and chemical stress, and allows for a more accurate representation of liver function by maintaining a higher number of viable cells for experimentation.

Implementation Method 1

centrifuging the pooled hepatocytes to cause pelleting of both viable and non-viable hepatocytes

Methodology Applied
Scientific EffectCentrifugal force: Centrifugal Force

Implementation Method 2

density gradient fractionation to separate viable and non-viable cells immediately prior to performing experiments

Methodology Applied
Scientific EffectDensity gradient: Density Gradient

Data Source

PatentEP3262156B1Method for pooling hepatocytes
Publication Date: 2021.06.23 LONZA WALKERSVILLE INC
  • EP3262156B1 patent drawingFigure 1A
  • EP3262156B1 patent drawingFigure 1B
  • EP3262156B1 patent drawingFigure 2A~2F

AI summary

The present invention relates to a novel method for the preparation of a pooled or mixed population of cryopreserved cells (e.g. hepatocytes). In particular, the invention entails the rapid thaw of cells (e.g. hepatocytes), donated from a single individual, which are mixed to create a heterogeneous population and then cryopreserved. The invention also concerns preparations of multi-cryopreserved cells to increase viability prior to immediate use. The process entails reducing exposure to chemical and physical stresses to increase the resultant number of viable cells.