Extracellular Vesicle Lyophilates Moisture Control
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for preparing therapeutic compositions involving extracellular vesicles (EVs) from bacteria face challenges in maintaining stability and efficacy, particularly during drying processes, due to high moisture content and instability of EVs.
Innovation Solution
The use of bulking agents like sucrose, mannitol, and lyoprotectants such as trehalose to create lyophilates with low moisture content (<6%), which improves handling and stability of EVs, and the incorporation of these agents in solutions and dried forms to maintain therapeutic efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If EVs are prepared as dried forms without sufficient moisture control, then handling ease is improved, but stability and therapeutic efficacy deteriorate
Solution Approach 1:
The patent applies parameter changes by precisely controlling the moisture content of dried EV forms to fall within the range of 3-15%, with optimal ranges of 5-10% or 7-12%. This specific parameter control resolves the contradiction by maintaining stability while ensuring handling ease, as the controlled moisture prevents both excessive dryness (which would compromise stability) and excessive moisture (which would hinder handling).
Solution Approach 2:
The patent employs composite materials by combining EVs with stabilizing agents such as sugars, proteins, or lipids to create dried formulations. These composite structures protect the EVs during drying and storage while maintaining therapeutic efficacy, thus resolving the contradiction between handling ease and stability by creating a composite material that possesses both properties.
2Ease of operation
If drying processes are applied to EV preparations, then ease of handling is improved, but EV stability and therapeutic efficacy may deteriorate due to improper drying conditions
Solution Approach 1:
The patent applies preliminary action by preparing EVs in a stable suspension or emulsion formulation before the drying process. This pre-preparation ensures that the EVs are protected and maintained in an stable state prior to drying, preventing degradation during the subsequent drying and storage phases while still achieving ease of handling in the final dried form.
Solution Approach 2:
The patent uses stabilizing agents as intermediaries between the EVs and the drying process. These agents (such as sugars, proteins, or lipids) mediate the drying process by protecting the EVs from damage while allowing the drying to proceed, thus enabling both ease of handling in the dried form and maintenance of EV stability throughout the process.
3Reliability
If moisture content is reduced below optimal levels in dried EV forms, then stability is improved, but handling properties and therapeutic efficacy may worsen
Solution Approach 1:
The patent applies parameter changes by establishing and maintaining moisture content within the specific range of 3-15% (with optimal ranges of 5-10% or 7-12%). This precise parameter control resolves the contradiction by ensuring that moisture is sufficient to maintain handling properties and therapeutic efficacy, yet low enough to ensure stability, avoiding both excessive moisture and excessive dryness.
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 approach results in stable EV lyophilates with controlled moisture content, enhancing their therapeutic effectiveness and ease of handling, while maintaining the integrity and functionality of the EVs.
Implementation Method 1
Bulking agents and/or lyoprotectants are used when preparing extracellular vesicles (EVs) for drying, such as freeze drying and spray drying
Implementation Method 2
lyoprotectants, including but not limited to trehalose, sucrose, and lactose protect the EVs during drying, such as freeze-drying or spray drying
Data Source
AI summary
Provided herein are solutions and dried forms of extracellular vesicles (EVs) that are useful as therapeutic agents, and therapeutic compositions thereof.