Recombinant Hemagglutinin Antigen Rosette Formation

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Solution Overview

Problem

Current methods for producing influenza vaccines, such as those using egg-based systems, face challenges including limited strain growth, antigenic drift, egg allergies, and supply disruptions, while recombinant hemagglutinin (rHA) vaccines struggle with maintaining immunogenicity and correct quaternary structure.

Innovation Solution

A recombinant influenza virus hemagglutinin (rHA) antigen is developed, comprising the extracellular domain, a hydrophobic transmembrane domain, and a heterologous trimerization domain, specifically incorporating a foldon and histidine tag for proper folding and rosette structure formation, avoiding large aggregates and maintaining immunogenicity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If egg-based methods are used for vaccine production, then large-scale production is achieved, but antigenic drift and suboptimal protection occur

Engineering Contradiction:
Improvevaccine production scaleVSAvoidprotection efficacy
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The patent extracts only the essential antigenic components (HA and NA proteins) from the virus and produces them recombinantly in cell culture, eliminating the need for live virus propagation in eggs. This extraction of the core immunogenic elements allows production without the antigenic drift problems inherent in egg-based systems.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent creates recombinant copies of the HA and NA proteins using synthetic or cloned genes expressed in mammalian cells. These recombinant proteins are functional copies that maintain immunogenicity while being produced under controlled conditions without requiring egg adaptation, thus preventing antigenic drift.

Inventive Principle:
Principle #26Copying

2Object-affected harmful factors

If recombinant hemagglutinin (rHA) is produced in culture cells, then egg allergy safety is improved, but immunogenicity and quaternary structure maintenance deteriorate

Engineering Contradiction:
Improveegg allergy hypersensitivityVSAvoidimmunogenicity
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent changes the production parameters by using mammalian cell culture systems (such as HEK293 or CHO cells) that properly fold and glycosylate the HA and NA proteins, maintaining their native quaternary structures and immunogenicity. This parameter change from bacterial to mammalian expression systems resolves the immunogenicity issue while maintaining the egg-free advantage.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If recombinant hemagglutinin (rHA) is produced in culture cells, then production control is improved, but correct rosette structure formation deteriorates

Engineering Contradiction:
Improveproduction controlVSAvoidrosette structure
Core Design Contradiction:
Manufacturing precisionVSShape

Solution Approach 1:

The patent uses mammalian cells as intermediary hosts that provide the necessary cellular machinery for proper protein folding, disulfide bond formation, and oligomerization. These cells act as mediators that enable the recombinant HA proteins to self-assemble into correct rosette structures while maintaining production control in a defined cell culture system.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP3423090B1Novel influenza antigens
Publication Date: 2023.08.30 GLAXOSMITHKLINE BIOLOGICALS SA
  • EP3423090B1 patent drawingFigure 1A~1B
  • EP3423090B1 patent drawingFigure 2
  • EP3423090B1 patent drawingFigure 3A~3B

AI summary

The present invention relates to novel influenza antigens, novel immunogenic or vaccine compositions, as well as to uses of and to methods for producing said antigens and compositions. In particular, the invention relates to recombinant forms of hemagglutinin (HA) and their use in vaccine compositions for the prevention of influenza virus infections.