Exosomes Part I: Applications and Downstream Processing Overview

Exosome Basics and Industrialization Challenges

Exosomes are cell-secreted vesicles with a diameter of 30-150 nm. They carry proteins, nucleic acids, and lipids, playing key roles in cell communication, disease diagnostics, drug delivery, and even skin regeneration.

However, large-scale production of exosomes still faces two major technical challenges. First, it’s difficult to balance separation efficiency and quality control. Traditional methods like ultracentrifugation struggle to achieve a balance between purity and yield. Second, precisely separating heterogeneous vesicles from similar particles like microvesicles remains difficult, which limits their clinical applications.

To address these issues, Cobetter’s R&D team has developed a modular solution system. Based on the needs of different application scenarios (such as therapeutic product manufacturing) we provide full-process technical support from sample pretreatment to purification and validation. For special sources or complex samples, we also offer customized process optimization services.

Exosome Sources and Applications

Exosomes come from a wide range of sources, mainly including mammalian cells, plants, and diary. Exosomes derived from mammalian cells, such as those from HEK293, CHO, MSC, and iPSC cells, have distinct functional characteristics and are used in areas like drug delivery, vaccine development, tissue repair, and anti-aging therapies. Plant-derived exosomes, such as those from citrus, grapes, and ginger, are resistant to gastric acid and have low immunogenicity, making them suitable for oral delivery with potential in functional foods and anti-tumor applications. Milk-derived exosomes, found abundantly in bovine and human milk, are rich in lactoferrin and miRNAs and can be used for food-grade or cosmetic product development. However, potential milk protein allergies should be considered during use.

Exosomes carry DNA, RNA, and proteins from their parent cells, which are found in various body fluids and remain highly stable. This makes them ideal biomarkers for liquid biopsy, useful for early cancer diagnosis and treatment monitoring. Both natural and engineered exosomes can modulate cell communication, showing promising results in tissue regeneration, immune regulation, and disease therapy. Moreover, their natural permeability and low toxicity make them excellent drug delivery vehicles. With surface modification and drug loading, they can enable targeted therapies such as targeted cancer treatment or crossing the blood-brain barrier for neurodegenerative disease therapy.

Exosome Downstream Purification and Process Solutions

To build a standardized testing process for exosomes from different sources (such as cell culture supernatants and body fluids) and various preparation methods (like centrifugation, ultrafiltration, and chromatography), Cobetter’s technical team has developed a comprehensive quality control system to ensure consistency and reliability in exosome production and application.

Through extensive testing and case studies, Cobetter has established a set of key analytical methods widely applicable across cosmetics, food, medical device, and pharmaceutical grades exosome products. This system follows three main principles—universality, scalability, and compliance—allowing it to adapt to diverse sample sources and process parameters while meeting regulatory standards such as GMP and ISO.

01 Food-Grade Exosome Production Process

Core requirements: Low-cost and efficient production that meets basic purity and activity standards.

Table 1 Food-grade exosome production process and testing parameters

02 Cosmetic-Grade Exosome Production Process

Core requirements: Low-cost and efficient production that meets basic purity and activity standards.

03 Medical Device–Grade Exosome Production Process

Core requirements: GMP compliance, ensuring sterility and batch-to-batch consistency.

Table 3 Medical device-grade exosome production process and testing parameters

04 Pharmaceutical-Grade Exosome Production Process

Core requirements: GMP compliance, high purity, and high bioactivity, meeting clinical safety and efficacy standards.

Table 4 Pharmaceutical-grade exosome production process and testing parameters