RNA Stabilizing Solution for Ambient Vaccine Storage
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Solution Overview
Problem
mRNA vaccines and RNA therapeutics face significant challenges due to rapid degradation at various temperatures, necessitating costly refrigeration and complex logistics for storage and transport, and existing stabilization methods are often toxic or impractical for human use.
Innovation Solution
A solution comprising ethylenediaminetetraacetic acid (EDTA) at 0.026M to 1M, tris(hydroxymethylaminomethane) (TRIS) at 0.001M to 3M, and a salt, such as NaCl, stabilizes RNA and mRNA-based vaccines, allowing safe injection and protection against degradation at ambient temperatures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If RNA is stored at low temperatures to maintain stability, then degradation is prevented, but storage and transport costs increase significantly
Solution Approach 1:
The patent changes the chemical parameters of the storage environment by introducing a stabilizing solution containing specific concentrations of salts (e.g., NaCl at 0.15M to 3M), chelating agents (e.g., EDTA at 0.026M to 1M), and buffering agents (e.g., TRIS at 0.001M to 3M). This chemical parameter modification allows RNA to maintain stability at higher temperatures, eliminating the need for costly refrigeration while preserving RNA integrity during storage and transport.
2Reliability
If conventional stabilization methods are used to prevent RNA degradation, then RNA integrity is maintained, but the methods are toxic or impractical for human use
Solution Approach 1:
The patent modifies the chemical composition parameters to create a stabilizing solution with physiologically compatible concentrations. By carefully controlling the molarity ranges of salts, chelating agents, and buffering agents, the solution achieves effective RNA stabilization while maintaining safety for human injection and administration, eliminating the toxicity issues associated with conventional stabilization methods.
Solution Approach 2:
The stabilizing solution acts as an intermediary between RNA and the harsh environment (temperature fluctuations, enzymatic degradation). The solution components—salts, chelating agents, and buffering agents—mediate protection by creating a protective chemical environment that prevents degradation mechanisms while being non-toxic to human cells upon administration.
3Reliability
If RNA is kept frozen during storage and transport, then degradation is minimized, but logistics complexity increases
Solution Approach 1:
The patent fundamentally changes the temperature parameter requirements for RNA storage by introducing the stabilizing solution. This allows RNA to be stored and transported at ambient temperatures rather than requiring frozen conditions, thereby simplifying logistics infrastructure and eliminating the need for specialized refrigeration equipment and cold chain management while maintaining RNA stability.
4Reliability
If refrigeration is used to maintain RNA stability, then degradation is prevented, but the need for refrigeration increases costs and reduces accessibility
Solution Approach 1:
The patent changes the environmental parameters required for RNA stability by formulating a stabilizing solution that allows RNA to remain stable at higher temperatures. This eliminates the dependency on refrigeration infrastructure, making RNA-based vaccines and therapeutics accessible in remote and resource-limited settings without requiring cold chain infrastructure, thereby significantly improving global distribution and ease of operation.
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 solution effectively stabilizes RNA and mRNA-based vaccines, enabling safe storage and transport at elevated temperatures, reducing the need for refrigeration and enhancing global distribution.
Implementation Method 1
The solution consists essentially of ethylenediaminetetraacetic acid (EDTA) having a molarity in the range of 0.026M to 1M... Multiple mechanisms of degradation exist and must be addressed for predictable RNA management, including oxidation by multiple reactive oxygen species, exposure to metallic ions, multiple catalytic agents
Implementation Method 2
tris(hydroxymethylaminomethane) (TRIS) having a molarity in the range of 0.001M to 3M... This process requires water and can be catalyzed by nucleases, but also by the mRNA molecule itself and other exogenous factors (such as Brønsted acids and bases)
Implementation Method 3
and a salt... The solution protects the nucleic acids, including RNA and RNA species such as mRNA, added to the solution against degradation
Data Source
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AI summary
Chemical compositions and/or mixtures that allow nucleic acid to remain stable at ambient temperatures. The disclosed technology includes a solution and manufacturing methods thereof. The solution includes a chelating agent, a buffering agent, and a salt. The solution is configured to protect RNA and/or an RNA-based vaccine added to the solution and prevents or reduces degradation of the RNA and/or the RNA-based vaccine for a duration of 2 to 180 days over a temperature range of -20 degrees C to + 38 degrees C. The chelating agent can comprise ethylenediaminetetraacetic acid (EDTA). The buffering agent can comprise tris(hydroxymethyl)aminomethane (TRIS). The salt can comprise NaCl. The solution is configured to preserve an injectable mRNA vaccine added to the solution, and the solution is safe for injection into mammals.