Artificial Polyclonal Immunoglobulin via Recombinant DNA

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Solution Overview

Problem

Current artificial monoclonal immunoglobulin preparations lack stability in properties and therapeutic effectiveness due to their monoclonal nature, posing challenges in quality control and infection risk associated with blood-derived sources.

Innovation Solution

Development of an artificial polyclonal immunoglobulin composition comprising multiple single chain variable fragments (ScFvs) with different heavy chain variable regions, produced using recombinant DNA technology to mimic the diversity of natural polyclonal immunoglobulins, which are then administered to model mice to demonstrate therapeutic efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If blood preparation is used for immunoglobulin, then therapeutic effectiveness is achieved, but infection risk increases

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidinfection risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent creates artificial immunoglobulins by copying the functional properties of natural immunoglobulins through recombinant DNA technology. The artificial immunoglobulins are synthesized in host cells based on genetic sequences, replicating the therapeutic function without using blood products, thereby eliminating infection risks associated with blood-derived sources while maintaining therapeutic effectiveness.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent replaces the mechanical process of blood extraction and concentration with a biological synthesis system using recombinant DNA technology. Instead of mechanically isolating immunoglobulins from blood, the invention uses genetic engineering to direct the production of immunoglobulins in host cells, substituting a potentially contaminated mechanical process with a controlled biological synthesis process.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Stability of the object's composition

If monoclonal immunoglobulin is used, then production stability is improved, but therapeutic effectiveness decreases

Engineering Contradiction:
Improveproduction stabilityVSAvoidtherapeutic effectiveness
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent merges the advantages of monoclonal and polyclonal immunoglobulins by creating an artificial polyclonal preparation that combines multiple monoclonal immunoglobulin sequences. This fusion approach maintains the production stability and consistency of monoclonal preparations while achieving the therapeutic effectiveness of polyclonal preparations through the combined diversity of multiple immunoglobulin clones.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a composite artificial immunoglobulin preparation that combines multiple different immunoglobulin sequences into a single polyclonal product. This composite approach integrates the stability of standardized monoclonal production with the therapeutic breadth of polyclonal diversity, resulting in a preparation that is both stable to produce and effective therapeutically.

Inventive Principle:
Principle #40Composite materials

3Reliability

If polyclonal immunoglobulin is used, then therapeutic effectiveness is improved, but quality control difficulty increases

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidquality control difficulty
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent uses recombinant DNA technology to copy and replicate specific immunoglobulin sequences with high precision. By using molecular cloning and genetic engineering, the patent can accurately reproduce the desired immunoglobulin sequences multiple times, ensuring consistent quality and making quality control manageable despite the polyclonal nature of the preparation.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The patent implements quality control through feedback mechanisms in the recombinant DNA production system. By monitoring the expression of immunoglobulin sequences in host cells and adjusting cultivation conditions, the patent can maintain consistent quality standards for polyclonal preparations, making quality control feasible despite the complexity of dealing with multiple different immunoglobulin types.

Inventive Principle:
Principle #23Feedback

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

The artificial polyclonal immunoglobulin composition shows high therapeutic effectiveness in alleviating symptoms of vasculitis and other inflammatory diseases with reduced infection risk and stable supply, demonstrating improved safety and efficacy compared to traditional preparations.

Implementation Method 1

produced using recombinant DNA technology to mimic the diversity of natural polyclonal immunoglobulins

Methodology Applied
Scientific EffectRecombinant DNA technology:

Implementation Method 2

has an action of protecting a living body by causing antigen-antibody reactions with foreign invaders such as bacteria

Methodology Applied
Scientific EffectAntigen-antibody reaction:

Data Source

PatentUS10196457B2Artificial immunoglobulin fragment composition
Publication Date: 2019.02.05 CHIBA UNIV
  • US10196457B2 patent drawing
  • US10196457B2 patent drawing
  • US10196457B2 patent drawing

AI summary

The present invention is intended to provide an artificial polyclonal immunoglobulin composition or artificial immunoglobulin fragment composition having a high therapeutic effect and high safety, and being capable of stable supply in a large amount. Specifically provided is an artificial polyclonal immunoglobulin composition containing, as active ingredients, 204 polypeptides represented by amino acid sequences set forth in SEQ ID NOS: 1 to 204 of the sequence listing, the polypeptides being plural kinds of single chain variable fragments (also referred to as ScFvs) each comprised of a heavy chain variable region, heavy chain constant region 1, and hinge region (VH-CH1-hinge) of an immunoglobulin, in which the heavy chain variable regions are different each other. An artificial immunoglobulin fragment composition is also provided that can include at least one polypeptide comprising an amino acid sequence set forth in SEQ ID NOS: 1 to 204, for example, SEQ ID NO. 31.