Exosomes / Extracellular Vesicles

Extracellular vesicles (EVs) are membrane-enclosed particles released by cells that carry proteins, lipids, and nucleic acids. Exosomes are commonly used to describe a subset of small EVs, although terminology and classification vary across the field. uBriGene offers exosome products derived from characterized iPSC and MSC master cell banks.

uBriGene isolates exosomes and extracellular vesicles from cell-culture supernatants using tangential flow filtration (TFF), followed by size-based chromatography/size-exclusion purification. This workflow supports exosomes concentration and purification while enabling downstream characterization and QC testing.

uBriGene's EV characterization and QC testing can include particle size distribution, particle concentration, morphology, protein markers, sterility, endotoxin, and functional potency. The specific testing panel depends on the EV product and intended application.

uBriGene recommends storing exosome and EV products at −80 °C for long-term storage. Storage and handling conditions should follow the product-specific instructions provided with each exosome product to help maintain product quality and biological activity.

MSC-derived exosome are being investigated for regenerative medicine, tissue repair, immunomodulation, wound healing, and musculoskeletal applications involving cartilage and bone. Their potential clinical applications remain under investigation, and research outcomes can vary with exosome source, manufacturing process, characterization, and product properties.

Exosomes can mediate communication between cells by transferring proteins, lipids, and nucleic acids. Their biological effects depend on the exosome source, molecular cargo, and recipient cells.

iPSC-derived exosomes are being investigated for applications in skin biology and cosmetic research because of their bioactive cargo and potential effects on cellular communication and tissue processes. Specific cosmetic or regenerative applications depend on the exosome source, characterization, formulation, and applicable regulatory requirements.

uBriGene produces exosome and EV products from characterized iPSC or MSC master cell banks. Production can use 2D adherent or 3D spheroid-based suspension culture systems in bioreactors, depending on the exosome product and manufacturing requirements.

uBriGene evaluates exosome biological activity using functional potency assays, including a wound-healing assay. Additional potency assays can be developed according to the product's intended function and application.

Yes. uBriGene supports scalable exosome production using both 2D adherent and 3D spheroid-based suspension culture systems in bioreactors. Manufacturing scale and process configuration are determined by the exosome source, product requirements, and development stage.

uBriGene maintains an active FDA Drug Master File (DMF #32642) for its mesenchymal stem cell (MSC)-derived exosome product. A DMF provides supporting CMC information for reference by FDA during applicable regulatory submissions; its use and relevance depend on the specific development program.

Yes. uBriGene provides GMP-focused exosome manufacturing capabilities, including upstream production, exosome isolation and purification, analytical characterization, QC testing, and process development. GMP manufacturing requirements are established according to the specific exosome product and intended application.

Key challenges in GMP exosome and EVs manufacturing include controlling source and process variability, defining critical quality attributes, achieving consistent purification and product quality, and establishing reliable characterization and potency assays. Because exosome properties depend on the source and manufacturing process, controls and testing should be tailored to the specific exosome product and intended application.