Highly Concentrated mRNA Gel Intermediates for Stable Storage
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Solution Overview
Problem
Current methods for preparing mRNA formulations involve continuous processes to avoid degradation, but these methods do not allow for stable storage of mRNA intermediates, leading to significant degradation over time.
Innovation Solution
Development of highly concentrated mRNA compositions, stored as a gel or viscous liquid, with concentrations ranging from 10 to 30 g/L, which exhibit enhanced stability at refrigerated temperatures, enabling storage for extended periods and allowing for non-continuous processing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If continuous processing is used to prepare mRNA formulations, then mRNA degradation is avoided, but stable storage of mRNA intermediates is not enabled
Solution Approach 1:
The patent applies parameter changes by concentrating mRNA to high concentrations (≥10 g/L) and forming gels or viscous liquids, which fundamentally alters the physical state and storage properties of mRNA. This concentration-dependent phase transition enables stable long-term storage while maintaining mRNA integrity, resolving the contradiction between reliability and storage duration.
Solution Approach 2:
The patent utilizes phase transitions by forming gel structures from concentrated mRNA solutions. The transition from soluble mRNA to gelated mRNA at high concentrations creates a stable physical state that can be stored long-term without degradation, enabling both high reliability and extended storage duration simultaneously.
2Reliability
If high concentration mRNA compositions are stored as gels, then storage stability is enhanced, but processing complexity increases
Solution Approach 1:
The patent applies preliminary action by forming concentrated gel compositions before final formulation steps. By preparing and storing the concentrated gel intermediate in advance, the process enables batch preparation and reduces the complexity of continuous processing, while maintaining storage stability through the gel state.
3Adaptability or versatility
If non-continuous processing is enabled through stable storage, then process flexibility improves, but mRNA degradation may occur during storage
Solution Approach 1:
The patent uses phase transitions to resolve this contradiction. By forming gels at high concentrations, mRNA enters a physical state that is both storage-stable and integrity-maintaining. This gel phase prevents degradation during non-continuous storage while enabling process flexibility, as the gel can be stored and then processed when needed.
Data Source
AI summary
Provided herein are compositions of highly concentrated mRNA and related methods for preparation and use of the compositions as mRNA process intermediates in the synthesis of therapeutic and prophylactic mRNA formulations.