Microfluidic Dimpled Channel for mRNA-LNP Room Temperature Stability

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Solution Overview

Problem

The limited shelf life and high distribution costs of mRNA-LNP vaccines due to their requirement for extremely low temperatures, as well as the challenges of scalability and reliability in producing nanoparticle compositions, necessitate the development of a more efficient and cost-effective solution for storage and distribution.

Innovation Solution

A microfluidic device with a microfluidic channel featuring dimples that create chaotic mixing and separate nanoparticles by size, allowing for the mixing of substances to form pharmaceutical complexes that can be stored and transported at room temperature, thereby extending the shelf life and improving distribution logistics.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If mRNA-LNP vaccines are stored at extremely low temperatures (−20 to −80 degrees Celsius) to extend shelf life, then the stability and effectiveness of the vaccine is improved, but the distribution cost and logistical complexity increase significantly

Engineering Contradiction:
Improvevaccine stabilityVSAvoiddistribution complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The invention changes the physical-chemical parameters of the LNP formulation to achieve room temperature stability. Specifically, the patent modifies the lipid composition and ratios within the nanoparticle structure, altering the phase transition temperature and membrane fluidity parameters to prevent aggregation and degradation at higher temperatures, thereby eliminating the need for extreme cold storage while maintaining vaccine effectiveness

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If mRNA-LNP vaccines are stored at extremely low temperatures to maintain effectiveness, then the chemical and physical stability is improved, but the distribution cost increases

Engineering Contradiction:
Improvevaccine stabilityVSAvoiddistribution cost
Core Design Contradiction:
Stability of the object's compositionVSLoss of energy

Solution Approach 1:

The invention modifies the formulation parameters of the LNP vaccine, specifically adjusting lipid composition and ratios to achieve a phase transition temperature suitable for room temperature storage. This parameter change reduces the energy required for cold chain maintenance during distribution while preserving vaccine stability and effectiveness

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If laboratory mixing devices are used to produce mRNA-LNP vaccines, then the mixing precision is improved, but the scalability and reliability decrease

Engineering Contradiction:
Improvemixing precisionVSAvoidscalability
Core Design Contradiction:
Manufacturing precisionVSProductivity

Solution Approach 1:

The invention replaces traditional mechanical laboratory mixing devices with a microfluidic mixing system. This substitution uses controlled fluid flow dynamics and diffusion principles to achieve precise mixing at the micro-scale, enabling both high manufacturing precision and scalability to production levels without the limitations of conventional mechanical mixers

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

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 microfluidic device enables the formation of stable pharmaceutical complexes that can be stored and transported at room temperature, reducing distribution costs and logistical complexities while maintaining the effectiveness of mRNA-LNP vaccines.

Implementation Method 1

dimples in the flow channel that create eddy channels with the flow path when a specific flow rate is achieved

Methodology Applied
Scientific EffectChaotic mixing: Turbulence

Implementation Method 2

The obstacle geometry may be specifically and purposefully designed to generate flow paths with different chaos and turbulence for different applications... different size nanoparticles will be moved to specific flow regions of the microfluidic channel, essentially separating the nanoparticles by size

Methodology Applied
Scientific EffectSize-based separation: Sedimentation

Data Source

PatentUS20240109066A1Microfluidic mixing and/or separater
Publication Date: 2024.04.04 WEST PHARMACEUTICAL SERVICES INC
  • US20240109066A1 patent drawing
  • US20240109066A1 patent drawing
  • US20240109066A1 patent drawing

AI summary

A microfluidic device may have at least one inlet channel; a microfluidic channel having a first portion fluidly connected to the at least one inlet channel; and at least one outlet channel fluidly connected to a second portion of the microfluidic channel, wherein the microfluidic channel has a plurality of dimples extending away from an axis of the microfluidic channel. The at least one inlet channel includes a first inlet channel and a second inlet channel, and/or the at least one outlet channel includes a first outlet channel and a second outlet channel. In some embodiments, the plurality of dimples may be configured to separate nanoparticles of different sizes to the first outlet channel and the second outlet channel.