Lipid Nanoparticle Vaccine Formulation for Cold Chain Stability

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Solution Overview

Problem

Current vaccines lack effectiveness in providing immunity against coronaviruses, such as SARS-CoV-2, due to instability outside the cold chain and limited immune response elicitation, especially in vulnerable populations like infants and older adults, and do not efficiently target spike proteins responsible for viral entry into host cells.

Innovation Solution

A lipid-based nanoparticle vaccine formulation incorporating nucleic acids encoding spike proteins of coronaviruses, including SARS-CoV-2, is developed, utilizing a liposomal delivery system with a positively charged lipid layer to enhance cell targeting and immune response, allowing for stability outside refrigeration and efficient antigen presentation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional vaccines are used, then vaccination can be administered, but they lack effectiveness due to instability outside the cold chain and limited immune response elicitation

Engineering Contradiction:
Improvevaccine effectivenessVSAvoidstability outside cold chain
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent modifies the physical and chemical parameters of the vaccine formulation by incorporating nucleic acids encoding spike proteins into a lipid-based nanoparticle delivery system. This encapsulation changes the stability parameters of the vaccine, allowing it to maintain structural integrity and functionality outside the cold chain while preserving immunogenicity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The invention creates a composite vaccine formulation combining nucleic acids (encoding spike proteins) with lipid-based nanoparticle materials. This composite structure provides both the immunogenic functionality of the nucleic acid and the stability properties of the lipid nanoparticle carrier, resolving the contradiction between effectiveness and stability.

Inventive Principle:
Principle #40Composite materials

2Reliability

If conventional vaccines are used, then vaccination can be administered, but they do not efficiently target spike proteins responsible for viral entry into host cells

Engineering Contradiction:
Improveimmune response elicitationVSAvoidefficient antigen presentation
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The lipid-based nanoparticle delivery system acts as an intermediary carrier that efficiently delivers nucleic acids encoding spike proteins to host cells. This intermediary system enhances antigen presentation by facilitating cellular uptake and expression of the spike protein, thereby improving immune response elicitation without complicating the manufacturing process.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If a nanoparticle delivery system with positively charged lipid layer is used, then cell targeting and immune response are enhanced, but formulation complexity increases

Engineering Contradiction:
Improvecell targeting efficiencyVSAvoidformulation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent modifies the surface charge parameter of the lipid nanoparticle formulation by incorporating positively charged lipids. This parameter change enhances cell targeting efficiency through electrostatic interactions with negatively charged cell membranes while maintaining a relatively simple overall formulation structure that does not require complex manufacturing processes.

Inventive Principle:
Principle #35Parameter changes

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 vaccine formulation induces a strong immune response, generating coronavirus-neutralizing antibodies and providing significant protection against coronaviral infections, with improved stability and flexibility for scalable production and administration.

Implementation Method 1

a primary alkyl amine including a positively charged amino group head and at least a carbon tail

Methodology Applied
Scientific EffectElectrostatic attraction: Electrostatics

Data Source

PatentUS11559577B2Immunogenic composition forming a vaccine, and a method for its manufacture
Publication Date: 2023.01.24 ENGIMATA INC
  • US11559577B2 patent drawing
  • US11559577B2 patent drawing
  • US11559577B2 patent drawing

AI summary

An immunogenic composition forming a vaccine includes a nanoparticle delivery system comprising at least a nanoparticle, wherein the at least a nanoparticle comprises a lipid layer exterior including a plurality of lipids, cholesterol, and a primary alkyl amine including a positively charged amino group head and at least a carbon tail and an antigen incorporated in the at least a nanoparticle, wherein the antigen comprises a nucleic acid encoding a protein from a coronavirus.