Technology Overview
ITRI provides one-stop exosome isolation and analysis services using TFF and SEC columns developed in collaboration with industry partners. From isolation to characterization, the service ensures high recovery and high purity of exosomes.
This advanced EV separation and purification technology leverages the benefits of Tangential Flow Filtration (TFF) and Size Exclusion Chromatography (SEC). TFF is first used for preliminary screening to remove most proteins and concentrate the sample. The sample then undergoes further separation of residual proteins in the SEC column. This two-step purification process can handle large sample volumes, facilitating large-scale EV production with minimal protein residue. Additionally, special surface treatment reagents have been developed for the TFF and SEC columns, resulting in higher EV recovery rates and reduced purification time compared to commercial products.
Exosomes are vesicles rich in diverse biological molecules, which complicates the elucidation of their mechanisms of action and the implementation of quality control. Our service combines comprehensive exosome characterization with multi-omics analyses to ensure the safety and efficacy of therapeutic exosomes, facilitating faster drug development and improved product quality.
Features & Specifications
Features
Extracellular Vesicles Isolation and Purification Services
- This technology involves the development of special surface treatment reagents for two different columns, TFF and SEC, which can enhance the affinity of samples for membranes or gels, shorten separation time, and reduce the adhesion of extracellular vesicles/exosomes to the columns, thereby increasing their recovery rate.
- The exosome separation method developed by this technology is suitable for various sample sources, including cell culture media from different sources and plasma with a wide range of applications.
- The exosome separation method developed by this technology does not destroy the structure and activity of extracellular vesicles/exosomes and is non-toxic, making it directly applicable to pharmaceutical or cosmetic products.
Service for Exosome Analysis and Testing
- Multi-omics technology is used to analyze the composition of exosomes, enabling differential comparison to identify batch variations and critical quality attributes.
- Establishes a comprehensive testing platform in accordance with regulatory requirements, enhancing functional analysis and facilitating integration with exosome CMC.
- Cross-species compatibility, applicable to exosome identification and analysis from most species.
Specifications
Extracellular Vesicles Isolation and Purification Services
- This technology's exosome/extracellular vesicle separation and purification process combines the benefits of TFF, which can handle and pre-concentrate large volumes of cell culture media, with SEC, known for its high protein removal efficiency. This allows for the rapid and efficient purification of biologically active exosomes/extracellular vesicles with minimal protein residue from large volumes of cell culture media. The recovery rate and purity of the exosomes/extracellular vesicles are superior to other commercial products available domestically and internationally.
- This process is also suitable for large-scale production. In the future, it can be integrated with automated production systems to reduce operation time and labor requirements, thereby enhancing production efficiency.
Service for Exosome Analysis and Testing
- Performs integrated multi-omics analysis to characterize exosome components such as nucleic acids, proteins, and lipids.
- Supports functional prediction and mechanism-of-action elucidation through bioinformatics and database integration.
Applications & Benefits
Extracellular Vesicles Isolation and Purification Services
- Our developed exosome/extracellular vesicle separation and purification process is designed to support the industrial service needs of both domestic and international companies, assisting in the separation and analysis of exosomes.
- We are collaborating with domestic instrument manufacturers to integrate TFF and SEC systems into automated processes.
Service for Exosome Analysis and Testing
- Accelerates drug development by rapidly identifying functional components and elucidating mechanisms of action.
- Improves formulation quality by monitoring composition, active molecule content, and minimizing contamination.
- Reduces development costs through early detection of safety and efficacy issues.
- Supports manufacturing processes by facilitating the analysis of both intermediates and final products to refine production and ensure regulatory compliance.