RNA Stabilizing Compositions for Above-Freezing Storage
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Solution Overview
Problem
The instability of RNA due to its single-stranded nature and susceptibility to hydrolysis complicates storage and requires extreme low temperatures, adding complexity and cost to storage, transportation, and administration of RNA-based therapeutics.
Innovation Solution
Compositions comprising RNA stabilizing substances that improve RNA stability at temperatures above freezing, reducing the need for refrigeration by stabilizing RNA in storage environments and maintaining integrity with cellular uptake agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If RNA is stored at extreme low temperatures (below freezing), then RNA stability is improved, but storage complexity and cost increase due to refrigeration requirements
Solution Approach 1:
The patent changes the chemical parameters of the storage environment by introducing specific stabilizing substances (sugars, polyols, amino acids) that chemically interact with RNA to prevent degradation. This allows RNA to maintain stability at higher temperatures without requiring extreme cold storage infrastructure
Solution Approach 2:
The patent uses stabilizing substances as intermediary molecules that mediate between RNA and the storage environment. These intermediaries (such as trehalose, sucrose, mannitol) form protective complexes with RNA, shielding it from degradation mechanisms and enabling stable storage at ambient or refrigerated temperatures without extreme freezing
2Reliability
If RNA is stored at extreme low temperatures, then RNA degradation is prevented, but transportation and administration complexity increase
Solution Approach 1:
By changing the chemical composition of the storage medium to include stabilizing agents, the patent enables RNA to maintain its structural integrity at temperatures compatible with standard transportation and clinical storage infrastructure, eliminating the need for specialized cryogenic transport systems
3Stability of the object's composition
If RNA stabilizing substances are added to compositions, then RNA stability at ambient temperatures is improved, but composition complexity increases
Solution Approach 1:
The patent applies stabilizing substances locally to the RNA molecule through specific molecular interactions, where each stabilizer targets specific degradation pathways (hydrolysis, oxidation, enzymatic degradation). This localized protection approach allows the use of multiple different stabilizers for different degradation mechanisms without requiring high concentrations of any single substance, thereby managing composition complexity
Data Source
AI summary
The present disclosure provides compositions and methods for producing and manufacturing compositions comprising at least one or more RNA stabilizing substance and at least one or more substance comprising extracellular RNA, wherein the compositions and methods of use provided herein improve the storage and stability of substances comprising extracellular RNA or based on RNA at temperatures above freezing temperatures without lyophilization. The present disclosure, further provides compositions for improving the stability of pharmaceutical compositions comprising RNA substances or based on RNA substances, including the stability of RNA in conjunction with nanoparticles or lipid-nanoparticles and applications for improving the storage and stability of pharmaceutical compositions comprising RNA or RNA substances above freezing temperatures without lyophilization. The present disclosure also provides descriptions of kits and methods for providing or producing kits for producing compositions comprising at least one or more RNA stabilizing substance.