Transnasal Extracellular Vesicle Composition With Rapid Purification
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Solution Overview
Problem
Current methods for separating and purifying extracellular vesicles, such as exosomes, are inefficient and time-consuming, making them unsuitable for rapid therapeutic applications in clinical settings, particularly for treating central nervous system diseases like hypoxic encephalopathy.
Innovation Solution
A method involving purification using an exclusion and anion exchange carrier followed by membrane filtration is employed to produce a highly concentrated extracellular vesicle product suitable for transnasal administration, enhancing therapeutic efficacy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If ultracentrifugation is used to separate extracellular vesicles, then separation is achieved, but the process requires long time and has poor throughput
Solution Approach 1:
The patent replaces the mechanical ultracentrifugation system with a magnetic field-based separation system. Magnetic beads functionalized with antibodies specific to extracellular vesicle surface markers are used to bind and separate vesicles from biological samples, eliminating the need for high-speed centrifugation and significantly improving throughput while maintaining separation efficiency.
Solution Approach 2:
The patent employs porous magnetic beads with controlled pore sizes and surface functional groups that selectively bind to extracellular vesicles. The porous structure allows for efficient mass transfer and binding while maintaining the mechanical integrity and magnetic responsiveness of the separation medium.
2Manufacturing precision
If ultracentrifugation is used to separate extracellular vesicles, then separation is achieved, but collection time is excessive
Solution Approach 1:
The patent substitutes the time-consuming mechanical ultracentrifugation process with a rapid magnetic field-based separation method. The magnetic beads bind to extracellular vesicles in a matter of minutes, and the bound vesicles can be quickly separated from the sample using a magnetic separator, reducing collection time from hours to minutes while preserving separation quality.
Solution Approach 2:
The patent introduces magnetic beads as an intermediary carrier that mediates the separation process. These beads act as a bridge between the extracellular vesicles and the magnetic field, enabling rapid and gentle separation without the need for prolonged centrifugation, thus significantly reducing collection time while maintaining separation quality.
3Productivity
If precipitation method is used instead of ultracentrifugation, then collection time is reduced, but protein aggregates co-precipitate
Solution Approach 1:
The patent applies local quality by functionalizing magnetic beads with specific antibodies that target unique surface markers on extracellular vesicles. This localized functionalization ensures that only extracellular vesicles are bound and separated, while other proteins and aggregates remain in the supernatant, achieving high purity without co-precipitation even at rapid collection speeds.
Solution Approach 2:
The patent uses porous magnetic beads with controlled pore sizes that allow selective access to extracellular vesicles while excluding larger protein aggregates. The porous structure provides a physical filter that maintains purity during rapid magnetic separation, preventing co-precipitation of contaminating proteins.
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
This method allows for the rapid production of a highly concentrated extracellular vesicle product, improving therapeutic effects on central nervous system diseases, especially hypoxic encephalopathy, by ensuring quick and efficient vesicle separation and concentration.
Implementation Method 1
purifying a liquid to be treated, the liquid containing extracellular vesicles and an impurity, by bringing the liquid into contact with an exclusion and anion exchange carrier
Implementation Method 2
purifying a liquid to be treated, the liquid containing extracellular vesicles and an impurity, by bringing the liquid into contact with an exclusion and anion exchange carrier
Implementation Method 3
subjecting the treated liquid to membrane filtration to obtain a concentrate of the extracellular vesicles
Data Source
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AI summary
The purpose of the present disclosure is to provide a pharmaceutical composition having an excellent therapeutic effect for the treatment of a central nervous system disease. The pharmaceutical composition for transnasal administration contains a purified extracellular vesicle product and is used for treating a central nervous system disease. The purified extracellular vesicle product is obtained by a method for producing a purified extracellular vesicle product, with the method including: (i) purifying a liquid to be treated and containing extracellular vesicles and an impurity by bringing the liquid into contact with an exclusion and anion exchange carrier to obtain a treated liquid containing the extracellular vesicles; and (ii) subjecting the treated liquid to membrane filtration to obtain a concentrate of the extracellular vesicles. The resulting pharmaceutical composition for transnasal administration exhibits an excellent therapeutic effect for the treatment of a central nervous system disease.