Exosomes are nanoscale extracellular vesicles (EVs) secreted by cells, ranging in size from 30 to 150 nanometers (nm). They are commonly found in bodily fluids such as blood, urine, saliva, and others.
Initially, exosomes were mistakenly considered cellular waste products. It was not until 1987 that Johnstone's team officially coined the term "Exosome" (from "Exo-" meaning external, and "-some" meaning body-like). Subsequent research progressively unveiled that secreted exosomes carry specific biomarkers and biological information, such as microRNAs (miRNA). A pivotal breakthrough occurred in 2007 when Jan Lötvall's team demonstrated that exosomes act as mediators of genetic exchange between cells, capable of encapsulating and transferring functional biological information to regulate recipient cells. This landmark finding laid the foundation for subsequent applications, including exosome biomarkers, exosome therapy, and miRNA drug carriers.
A major turning point that brought exosomes into the spotlight occurred in 2013, when James Rothman, Randy Schekman, and Thomas Südhof were awarded the Nobel Prize in Physiology or Medicine for elucidating the mechanisms regulating intracellular vesicle transport and secretion. Following this discovery, exosomes began to gain widespread attention. As downstream applications became better understood, exosomes evolved from being viewed as an “intracellular logistics platform” to an “intercellular logistics platform,” paving the way for a broad spectrum of subsequent clinical applications.
Exosomes are characterized by their nanoscale vesicular size and bilayer lipid membrane. They are rich in various bioactive components, including growth factors, nucleic acid fragments, and cytokines. They possess the ability to promote tissue repair, reduce inflammation, and activate cells. Currently, exosomes are widely applied in medical disease diagnostics, aesthetic care, beauty product, and health management.
The functions of exosomes vary depending on their cellular origin, with each type exhibiting distinct biological functions and their applications:
As exosome research advances, diverse exosome types are emerging as powerful tools in precision health management, regenerative medicine, and disease therapy.
Due to their function in cellular communication and promotingtissue repair, exosomes have emerged as one of the most talked-about innovations in regenerative medicine and cosmetic applications. But are exosomes truly effective? Can they genuinely delay aging? Herein, we will present you a simple guide to understand the critical characteristics and application potential of exosomes from a scientific perspective:
Although exosomes are generally regarded as safe, ensuring product quality remains critical. The source, purification method, and storage conditions of exosomes directly affect their safety and stability. Consumers should avoid products of unknown origin or those lacking information on purity and concentration, as such products may cause unexpected skin irritation or other safety concerns.
Exosomes themselves exhibit high safety, and generally do not cause risks like immune rejection or abnormal cell proliferation. Side effects are rare and, if any, are typically transient. Temporary mild reactions observed after using exosome-related products (such as serums, masks, or injectables) often include:
These reactions are usually associated with products made by unknown or unqualified manufacturers. Consumers should be cautious and choose only products from reliable sources. Avoid using exosome products that lack essential information such as a Certificate of Analysis (CoA), details on cell origin, as these may pose potential safety risks.
While exosomes are safe in most scenarios, the following groups are advised to consult a professional physician or dermatologist before use:
Cell cultures contain various particles of different sizes and functions, such as cell debris, proteins, and other residual ingredients from cell culture medium. Therefore, rigorous purification procedures are essential to effectively isolate genuine exosomes, maintaining their integrity and functionality. This is the key to prepare high quality exosome. Here is a table to compare several common exosome purification technologies, detailing their advantages, disadvantages, and application fields:
|
Methods |
Purity |
Time |
Cost |
Advantage |
Disadvantage |
Applicable |
|
Ultracentrifugation (UC) |
Medium |
Lengthy |
Medium |
Can handle large volume |
Time-consuming, low recovery rate, hard to purify completely. |
Lab-scale research for initial isolation |
|
Size Exclusion Chromatography (SEC) |
Medium-High |
Quick |
Medium |
Stability with preserved integrity |
Further purification needed |
Integrity matters (e.g., functional assays, diagnosis) |
|
Tangential Flow Filtration (TFF) |
Medium-High |
Quick |
Medium-High |
Large-scale production, high-efficiency and continuous production |
High purity needs to be achieved by combining other methods |
Suitable for large-scale production, product development, and industrial manufacturing. |
|
Ultrafiltration (UF) |
High |
Quick |
Medium |
Simple protocol without reagents involved |
Membrane clogging possible and the pressure may damage particles and denature proteins |
Quick lab preconcentration from low-viscosity fluids |
|
Precipitation |
Low |
Medium |
Low |
Simple and fast |
Difficult to separate polymers, low purity |
Rough purification for preliminary analysis |
|
Immunoaffinity Isolation (IA) |
High |
Lengthy |
High |
High purity, strong specificity |
High cost, low yield |
Biomarker research; very-low scale production |
To achieve reproducibility, standardized manufacturing procedures (including cell culture technologies and purification method) are essential. In addition, quality control (QC) tests are also important:
· Quantitative and qualitative analysis: Characterization using multiple analytical techniques, including protein profiling, nanoparticle tracking analysis (NTA), and biomarker assessment.
· Comprehensive data presentation: Provides particle size distribution graphs, quantitative marker data, and content analysis.
· Cell’s CoA: Verifies cell origin and quality.
· Safety assessment: Includes microbiological testing.
The quality of exosome and its safety rely on rigorous purification processes and characterization methods. For clinical-grade exosomes, it is essential not only to comply with production standards in clinical facilities and to select cells meeting clinical specifications, but also to employ identification methods that confirm exosome-specific characteristics and functionality. These factors are critical to ensuring both efficacy and safety.
Gwo Xi Stem Cell leverages decades of experience in stem cell medicine development and clinical practice to implement clinical-grade manufacturing with GMP-compliant processes. We have established a dedicated exosome R&D and manufacturing platform, offering global partners safe, stable, diversified, and flexible Exosome Contract Development and Manufacturing (CDMO/CMO) services.
Three Core Advantages of Exosomes from Gwo Xi Stem Cell:
1. Clinical-Grade Exosome Preparation
Gwo Xi Stem Cell's preparation process is conducted in the GMP-compliant facilities, ensuring product safety and efficacy. Our rigorous standards encompass every step, from cell source selection and culture conditions to purification methods and final quality inspection.
2. Cross-Industry Application and Customized Integration
Gwo Xi Stem Cell offers comprehensive exosome CDMO services, tailored to meet partners’ needs. Our capabilities span cosmeceutical raw material supply, aesthetic medicine application development, preclinical research support, and pet regenerative healthcare solutions.
3. International Certification and Patent Portfolio
Gwo Xi Stem Cell is the first company in Taiwan to obtain the International Nomenclature of Cosmetic Ingredients (INCI) certification for Human Adipose Derived Mesenchymal Stem Cell Exosomes (Mono ID: 37487). With 14 exosome-related patents, we rank at the forefront of the industry and possess dual application advantages in both medical and cosmetic sectors.
Gwo Xi Stem Cell has partnered with Cell 101 International Sdn Bhd in Malaysia to advance the application of mesenchymal stem cells (MSCs) and exosomes across multiple fields, including tissue regeneration, healthcare, medical aesthetics, and home care. Leveraging Gwo Xi Stem Cell’s PIC/S GMP manufacturing facility, along with its expertise in process development and clinical-grade products, the collaboration integrates Cell 101’s strategic presence in the Southeast Asian medical market to establish a complete value chainfrom technology to manufacturing andmarket.
At the same time, Gwo Xi Stem Cell is actively seeking global partners to provide comprehensive CDMO services, spanning R&D, therapeutic applications, medical aesthetics, skincare, and nutraceuticals. Through this cross-border and cross-disciplinary approach, Gwo Xi Stem Cell continues to drive innovation and forge international collaborations, opening a new chapter in regenerative medicine worldwide.

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l Johnstone RM, Adam M, Hammond JR, Orr L, Turbide C. Vesicle formation during reticulocyte maturation. Association of plasma membrane activities with released vesicles (exosomes). J Biol Chem. 1987;262(19):9412-9420.
l Valadi H, Ekström K, Bossios A, Sjöstrand M, Lee JJ, Lötvall JO. Exosome-mediated transfer of mRNAs and microRNAs is a novel mechanism of genetic exchange between cells. Nat Cell Biol. 2007;9(6):654-659. doi:10.1038/ncb1596
l Lotvall J, Valadi H. Cell to cell signalling via exosomes through esRNA. Cell Adh Migr. 2007;1(3):156-158. doi:10.4161/cam.1.3.5114