Exosome CDMO

Exosomes demonstrate tremendous potential in cellular communication and regulation of biological activity. In particular, stem cell-derived exosomes have become a focal point in regenerative medicine and the biotech industry.

However, with the explosive growth of related products in the market, we must raise an important question:Are you really using genuine exosomes?

Purification TechnologyPurification technology is the core key to ensuring exosome quality. Since cell culture supernatants contain a variety of particles of different sizes and functions—such as cell debris, proteins, and other extracellular vesicles—only through rigorous purification processes can genuine exosomes be effectively isolated while preserving their integrity and functionality.

At presentPublished by the International Society for Extracellular Vesicles《MISEV2023》Aiming to provide detailed guidelines for the purification and analysis of exosome research:

• Employ a multi-step purification process
• Select purification techniques based on sample characteristics
• Filtration or column chromatography is recommended to enhance purity.
• Standardization and Transparency of Purification Methods

Even with highly efficient purification techniques, it is impossible to guarantee the consistent isolation of pure exosomes every time. At this point,Identification TechniquesThey become essential tools for confirming the authenticity of purified exosome products.

• Characterization and identification using multiple analytical techniques
• Use control groups to verify the accuracy of results
• Provide comprehensive data presentation, including particle size distribution graphs, quantitative marker data, and content analysis.

Only through rigorous purification and precise identification techniques can the quality and safety of exosomes be ensured. For clinical-grade exosomes, in addition to meeting clinical standards, the source of clinical-grade cells is equally critical, along with identification methods that confirm exosome characteristics and functionality.

 Exosome Purification and Analytical Techniques: Guidelines Based on MISEV2023

GWOXI stem cells possess an exclusive exosome technology platform. In addition to having a cell bank and manufacturing facilities that meet clinical-grade standards, we provide comprehensive safety and functional testing of exosomes to ensure the purity and stability of exosome products, fully meeting clients’ contract manufacturing needs.

Feeling weak knees during outings? Experiencing numbness in your hands or feet after staying in the same position too long? Is your sleep quality worsening as you age? Noticing fine lines under your eyes and dull skin tone, with a growing sense of fatigue?

These signs indicate that our bodies are aging. Maintaining health and slowing down aging are goals we all aspire to. With advances in medical technology and skincare, delaying aging is no longer an unattainable dream! Recently, exosomes have become a rising star in the field of anti-aging.

Exosomes are an emerging medical technology making waves in clinical medicine, aesthetics, cosmetics, and even anti-aging research. But what exactly are exosomes? How did they rise from obscurity to become a new choice in the medical field? This article will take you on a journey to explore the true value of exosomes.

1. What are exosomes?

The following summarizes the exosome research guidelines based on the International Society for Extracellular Vesicles’ (ISEV) MISEV2023 recommendations.

• exosomesExosomes are a subtype of extracellular vesicles (EVs).，Exosomes are nanoscale vesicles, ranging from 30 to 150 nm, secreted by cells.
• Exosomes possess a bilayer phospholipid membrane structure similar to the cell membrane. They are taken up by recipient cells through mechanisms such as fusion, endocytosis, and receptor-mediated interactions, enabling efficient intercellular communication. The signaling molecules carried by exosomes participate in various physiological and pathological processes between cells.
• The signaling molecules within exosomes include proteins, nucleic acids, cytokines, and various growth factors.
• All cells secrete exosomes, with those derived from humans, animals, and plants being the most common. Among these, exosomes secreted by human stem cells are the most widely studied and well-known in research.
• Exosomes can be collected from a wide range of sources, including tissues, cerebrospinal fluid, urine, blood, saliva, and cell culture media. The cargo carried by exosomes varies depending on their origin. Additionally, differences in purification techniques can affect the purity, contaminants, allergenicity, safety, and efficacy of the exosome preparations.
• Therefore, when choosing exosomes, consider asking these three questions: What is the cellular source of the exosomes? Is there sufficient evidence supporting their safety and efficacy? Are they truly genuine exosomes?

(Further Understanding：Exosome Purification and Analysis Techniques According to MISEV2023 Recommendations)

2. Diverse Applications of Exosomes

• Cosmetics：Exosomes are gaining increasing attention in the cosmetics field, particularly in skin repair and anti-aging skincare products, where they have become an indispensable key ingredient. Containing various growth factors, proteins, and lipids, exosomes effectively nourish skin cells, promote collagen synthesis and skin regeneration, and provide antioxidant and anti-inflammatory benefits. Moreover, due to their small molecular size and high permeability, exosomes are more readily absorbed by the skin, allowing their encapsulated active ingredients to penetrate deeply and exert their effects. This has made exosomes a star ingredient in the cosmetics industry in recent years. (Further Understanding：Are exosome-based cosmetics legal?)

• Aesthetic medicine：In the field of aesthetic medicine, numerous studies have shown that stem cell-derived exosomes possess anti-inflammatory, immunomodulatory, antioxidant, and cell proliferation-promoting properties. Research also indicates their potential in accelerating skin repair and improving scarring. As a result, they hold great promise for use in treatments aimed at scar reduction, fine line improvement, and overall skin rejuvenation. (Further Understanding：Exosome technology is driving a new trend in aesthetic medicine.)

• Medical technology：The application of exosomes in medical technology spans regenerative medicine, cancer therapy, and immunomodulation. In regenerative medicine, exosomes are regarded as a vital extension of stem cell therapy, capable of delivering key biological signals to support the repair of damaged tissues. In the field of cancer research, exosomes are used as carriers for targeted drug delivery, enabling therapeutic molecules to reach cancer cells with high precision and thereby enhancing treatment efficacy. Additionally, the potential of exosomes in immunomodulation has gained increasing attention, as they can regulate immune responses and reduce inflammation.

3. A New Choice in Medical Care---Mesenchymal Stem Cell-Derived Exosomes

Among the many sources of exosomes, mesenchymal stem cell-derived exosomes have emerged as a promising new option for disease treatment and regenerative medicine, thanks to their natural repair and regenerative capabilities, as well as their low immunogenicity.

• Mesenchymal Stem CellsMesenchymal stem cells possess regenerative, reparative, and homing abilities,with their therapeutic potential demonstrated in clinical (and preclinical) trials for multiple indications, including neurodegenerative diseases, cardiovascular regeneration, and tissue repair.
• Exosomes secreted by mesenchymal stem cells have been found to aid tissue repair and regeneration, regulate the immune system, suppress inflammatory responses, and promote wound healing.
• By modulating immune responses, promoting cell proliferation and regeneration, improving the microenvironment, and enhancing tissue repair, exosomes are considered to have potential therapeutic effects for various indications.
• Exosomes are nanoscale particles that can cross the blood-brain barrier (BBB), making them highly promising for brain-based therapies.
• Purified mesenchymal stem cell-derived exosomes exhibit high safety and compatibility, with a low risk of triggering immune reactions or other adverse effects.

Exosomes have multiple sources, and those derived from carefully reviewed stem cell sources, combined with rigorous clinical preparation standards and supporting documentation, undergo thorough verification. Only after such validation can stem cell-derived exosomes ensure both safety and efficacy, making them a promising new option for clinical medical treatments.

References

• Welsh, Joshua A et al. “Minimal information for studies of extracellular vesicles (MISEV2023): From basic to advanced approaches.” Journal of extracellular vesiclesvol. 13,2 (2024): e12404. doi:10.1002/jev2.12404
• Byung-Chul Lee et al. “Therapeutic Features and Updated Clinical Trials of Mesenchymal Stem Cell (MSC)-Derived Exosomes” J Clin Med. 2021 Feb 11;10(4):711. doi: 10.3390/jcm10040711.
• Bhushan N Kharbikar et al. “Biomaterials to enhance stem cell transplantation” Cell Stem Cell. 2022 Apr 27;29(5):692–721. doi: 10.1016/j.stem.2022.04.002