Plant-Produced TNFα Inhibitor Expression System

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Solution Overview

Problem

The production of TNFα inhibitors in mammalian cell systems is hampered by cellular fragility, complex nutritional requirements, and the risk of viral or prion contamination, highlighting the need for a safer and more efficient method to produce biopharmaceuticals like Etanercept.

Innovation Solution

The development of a plant-based expression system for producing a chimeric TNFα polypeptide inhibitor, specifically a TNFR2:Fc fusion protein, which includes a TNF-binding domain and an Fc domain of an immunoglobulin, fused with an endoplasmic reticulum retention signal, using plant cells like Nicotiana tabacum to avoid mammalian cell-derived contaminants and improve safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If mammalian cell systems are used to produce TNFα inhibitors, then the inhibitors can be produced with proper post-translational modifications, but the production is hampered by cellular fragility, complex nutritional requirements, and risk of viral contamination

Engineering Contradiction:
Improvesafety of biopharmaceutical productionVSAvoidcomplexity of production system
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent uses plant cells as an intermediary production system to replace mammalian cell systems. Plant cells serve as a mediator that can produce the TNFα inhibitor (etanercept) without the viral contamination risks associated with mammalian cells, while still providing necessary post-translational modifications through plant-specific pathways

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent employs transient expression systems in plant cells where the expression cassette is introduced temporarily without stable integration into the genome. This allows for disposable, short-term production systems that eliminate the need for complex permanent mammalian cell line development and reduce viral contamination risks

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

2Productivity

If mammalian cell systems are used to produce TNFα inhibitors, then the inhibitors can be produced, but the cells require complex nutritional requirements and show cellular fragility

Engineering Contradiction:
Improveproduction efficiency of TNFα inhibitorVSAvoidease of cell culture maintenance
Core Design Contradiction:
ProductivityVSEase of manufacture

Solution Approach 1:

Plant cells used in this patent can perform many metabolic functions autonomously, including their own nutritional synthesis. They require simpler culture media compared to mammalian cells and can maintain themselves without complex nutritional supplementation, thereby improving ease of manufacture while maintaining productivity

Inventive Principle:
Principle #25Self-service

3Manufacturing precision

If mammalian cell systems are used to produce TNFα inhibitors, then the inhibitors can be produced with proper folding and activity, but there is risk of viral or prion contamination

Engineering Contradiction:
Improveprotein folding and biological activityVSAvoidviral and prion contamination risk
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The patent converts the potential harm of using plant cells (which have different post-translational modification pathways) into a benefit by demonstrating that plant cells can still produce properly folded, active TNFα inhibitor proteins. The different modification pathways actually eliminate viral contamination risks while maintaining protein functionality

Inventive Principle:
Principle #22Blessing in disguise (Convert harm into benefit)

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 plant-produced TNFα polypeptide inhibitor retains TNFα binding activity, demonstrating effective apoptosis regulation and reduced immunogenicity, while eliminating the risk of viral contamination, thus providing a safer and more efficient alternative for treating TNFα-associated medical conditions.

Implementation Method 1

The development of a plant-based expression system for producing a chimeric TNFα polypeptide inhibitor

Methodology Applied
Scientific EffectBiological expression:

Implementation Method 2

secreted in the culture medium

Methodology Applied
Scientific EffectSecretion:

Implementation Method 3

TNF-alpha engages to its cognate receptors (TNFRI, p55 and TNFRII, p75), expressed ubiquitously

Methodology Applied
Scientific EffectMolecular binding:

Implementation Method 4

fused with an endoplasmic reticulum retention signal

Methodology Applied
Scientific EffectSignal sequence recognition:

Data Source

PatentEP2964668B1TNF alpha inhibitor polypeptides, polynucleotides encoding same, cells expressing same and methods of producing same
Publication Date: 2019.11.27 PROTALIX
  • EP2964668B1 patent drawingFigure 1
  • EP2964668B1 patent drawingFigure 2A~2B
  • EP2964668B1 patent drawingFigure 3

AI summary

A plant produced TNF alpha polypeptide inhibitor is provided. Also provided are methods of generating and using same.