Humanized Protein C Transgenic Mice for Therapeutic Testing

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Solution Overview

Problem

The lack of viable genetically modified non-human animals expressing human Protein C due to neonatal lethality of mice lacking protein C and inefficient function of human Protein C in mouse plasma hinders comprehensive in vivo studies for therapeutic agent testing.

Innovation Solution

Generation of genetically modified mice where both copies of the endogenous nucleotide sequence encoding Protein C are replaced with a nucleotide sequence encoding human Protein C, enabling expression of functional human Protein C fragments or variants, making them suitable models for testing therapeutic agents.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If mice lacking endogenous protein C are generated to study human Protein C, then the model would be useful for therapeutic testing, but the mice exhibit neonatal lethality

Engineering Contradiction:
Improveusefulness for therapeutic testingVSAvoidviability of mice
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The invention replaces the endogenous mouse Protein C gene with the human Protein C gene sequence, changing the genetic parameter to produce mice that express human Protein C instead of mouse Protein C. This allows the mice to be viable while serving as appropriate models for studying human Protein C function and testing therapeutic agents.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If human Protein C is expressed in mice, then the model would be relevant for human therapy, but human Protein C does not function efficiently in mouse plasma

Engineering Contradiction:
Improverelevance for human therapyVSAvoidfunctional efficiency of Protein C
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The invention replaces the entire endogenous mouse Protein C gene with the human Protein C gene, ensuring that mice express human Protein C with human plasma compatibility. This genetic parameter change allows human Protein C to function efficiently in the mouse system, making the model relevant for human therapy while maintaining functional efficiency.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3811777B1Genetically modified non-human animals humanised for protein c
Publication Date: 2024.07.31 SHANGHAI RAAS BLOOD PRODUCTS CO LTD
  • EP3811777B1 patent drawingFigure 1A~1B
  • EP3811777B1 patent drawingFigure 1C~1D
  • EP3811777B1 patent drawingFigure 2

AI summary

The present invention relates generally to genetically modified non-human animals. The present invention relates to a genetically modified non-human animal, in which at least one copy of the endogenous nucleotide sequence encoding Protein C in the genome of said non-human animal has been replaced by a nucleotide sequence encoding human Protein C, encoding a functional fragment of human Protein C or encoding a functional variant of human Protein C. The invention also relates to vectors, cells and methods for the production of such non-human animals. The invention also relates to methods of testing agents for their ability to alter to the level and/or functional activity of human protein C and thus provides methods of testing agents for their potential therapeutic efficacy.