Aqueous Viral Particle Stabilization Using Polyethyleneimine
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Solution Overview
Problem
Current methods for storing biological materials like proteins and viruses are unstable, requiring costly and time-consuming freeze-drying processes, and often necessitate reconstitution before use, which can be inconvenient and risky.
Innovation Solution
Development of storage-stable, ready-to-use aqueous solutions of viral particles or polypeptides using specific excipients and sugars, eliminating the need for drying steps and allowing direct administration without reconstitution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If freeze-drying is used to stabilise proteins and viral particles, then storage stability is improved, but the process is time-consuming and introduces stresses that can denature proteins
Solution Approach 1:
The patent extracts and eliminates the freeze-drying step from the formulation process by developing aqueous solutions with stabilizing excipients (polyethyleneimine and sugars) that maintain protein and viral particle stability without requiring removal of water through freeze-drying
Solution Approach 2:
The patent changes the formulation parameters by introducing specific excipients (polyethyleneimine at 15 μM or less and sugars at greater than 0.1M) that alter the chemical environment to prevent degradation, allowing stable storage in aqueous form without freeze-drying
2Stability of the object's composition
If freeze-drying is used to provide stable formulations, then storage stability is improved, but the process is costly and complex
Solution Approach 1:
The patent removes the complex freeze-drying equipment and process steps by using a simplified aqueous formulation approach with stabilizing excipients that achieves comparable or superior stability without requiring specialized freeze-drying infrastructure
Solution Approach 2:
The patent employs inexpensive excipients (polyethyleneimine and common sugars) that can be easily incorporated into aqueous formulations, replacing the need for expensive freeze-drying equipment and complex manufacturing processes
3Stability of the object's composition
If freeze-drying is used to stabilise biological materials, then storage stability is improved, but proteins may unfold or denature during the process
Solution Approach 1:
The patent applies beforehand cushioning by incorporating stabilizing excipients (polyethyleneimine and sugars) into the aqueous formulation before storage, which protect proteins and viral particles from denaturation and degradation during storage without requiring the stressful freeze-drying process
Solution Approach 2:
The patent converts the potential harm of water (which can cause hydrolysis and degradation) into a benefit by using aqueous formulations with stabilizing excipients that prevent degradation, thereby eliminating the need for freeze-drying while maintaining or improving stability
4Stability of the object's composition
If refrigerated transportation and storage are used, then stability is improved, but costs increase and availability is reduced in developing countries
Solution Approach 1:
The patent changes the storage parameters by developing aqueous formulations with stabilizing excipients that maintain stability at higher temperatures and for longer periods without refrigeration, thereby reducing distribution costs and improving availability in developing countries
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 solutions provide long-term stability, enabling safe and convenient storage and administration of biological materials, reducing costs and risks associated with reconstitution.
Implementation Method 1
drying an aqueous solution of one or more sugars, a polyethyleneimine and the viral particles to form an amorphous solid matrix comprising the viral particles
Implementation Method 2
an aqueous solution of one or more sugars, a polyethyleneimine and the viral particles
Data Source
AI summary
A sterile pharmaceutically acceptable aqueous solution, which solution is provided in a sealed container and comprises:a pharmaceutically acceptable aqueous solvent;viral particles or a physiologically active polypeptide;an excipient selected from a polyethyleneimine; a compound of formula (I) or a physiologically acceptable salt or ester thereof; or a compound of formula (II) or a physiologically acceptable salt or ester thereof; andoptionally, one or more sugars.