EVとエクソソームに関するご質問、 率直にお答えします。

Extracellular vesicles are nanoscale particles secreted by virtually every cell type. Each particle is a membrane-bound sphere built around a lipid bilayer, carrying a cargo of proteins, lipids, and nucleic acids that can influence gene expression and signalling in recipient cells. The field recognizes three subpopulations distinguished by biogenesis: apoptotic bodies, microvesicles (ectosomes), and exosomes from the multivesicular body pathway. The diagram below illustrates these three biogenesis routes from a single cell. "Exosome" is widely used in marketing as a synonym for EV, but technically refers only to particles produced through the multivesicular body pathway, which most commercial isolation methods cannot cleanly separate from other subpopulations. The International Society for Extracellular Vesicles (ISEV) recommends "extracellular vesicle" as the primary scientific term unless biogenesis has been experimentally confirmed. For the long-form treatment, see the blog article at /blog/ev-biogenesis-explained.

No, and this is the most critical thing to understand about the EV space. There is no such thing as a generic exosome product. Every EV preparation is unique, and its biological properties are entirely determined by: (1) the biological source, which cell type, tissue, organism, or plant species the EVs were isolated from; (2) the isolation method used; and (3) the processing and storage conditions applied. EVs from human stem cells, platelet-rich plasma, adipose tissue, and plant cells are all called "EVs" or "exosomes", but they carry completely different molecular payloads and have fundamentally different biological effects. This applies even across different suppliers claiming the same source: without standardized production and rigorous characterization, no two EV products can be assumed equivalent. The absence of industry-wide standardization means "exosome product" is a category, not a specification.

Yes, substantially so. The molecular payload of an EV is a direct reflection of the cell or organism that produced it. EVs from different cell types (e.g., fibroblasts vs. immune cells), different tissues (e.g., bone marrow vs. adipose), and different biological kingdoms (e.g., human vs. plant) carry entirely distinct protein profiles, RNA species, lipid compositions, and surface markers. These differences translate directly into different biological effects on recipient cells. This is not a minor technical nuance, it is the central reason why EV products cannot be compared without knowing the source and characterization data. A product made from human platelet-derived EVs is biologically incomparable to one made from plant nanovesicles, even if both are marketed under the same "exosome" label.

EVs represent a natural biological communication system, they are how cells transfer functional molecular information to one another. In dermatology, EVs show potential to support skin repair, modulate inflammation, promote regenerative signalling, and activate pathways involved in collagen synthesis and barrier function. Unlike synthetic cosmetic ingredients, EVs participate in cell-level biological signalling through mechanisms the body already uses. In medicine more broadly, EVs are being investigated as therapeutic agents and drug delivery vehicles. The evidence base is growing rapidly, though clinical validation remains an active and evolving area of research.

Peer-reviewed research, much of it preclinical, has linked extracellular vesicles to pathways associated with skin repair, including collagen synthesis, keratinocyte migration, extracellular matrix remodelling and the attenuation of inflammatory signalling. Results depend heavily on the vesicle source, the isolation method and how well the material is characterized, which is why we characterize every batch we produce. This is a summary of the scientific literature, not a claim about any product.

Plant-derived vesicles are our current source because they suit some applications particularly well. Plant biomass is renewable and abundant, production avoids the cost and complexity of large-scale cell culture, and no animal or human donor material is required, which removes donor screening from the process. Other sources have different strengths: vesicles from mammalian cells, including human stem cells, carry signalling molecules shaped by human biology and are among the most studied sources in therapeutic research. As we grow, our research extends to animal-derived sources for applications where their biology is the better fit.

How extracellular vesicles applied to the skin interact with it is an active topic of investigation, and our position reflects the current evidence rather than overstating it. The skin's outermost layer, the stratum corneum, is a tightly organized, lipid-rich barrier, and how particles the size of intact vesicles traverse or interact with that barrier under realistic topical conditions is an open question across the EV field. The pathways under study include interactions at the surface and upper epidermis, where vesicles deliver their cargo to cells in the upper skin layers, and a follicular route via hair follicles and sebaceous glands. We do not claim deep dermal penetration of intact vesicles. Our focus is on characterizing the vesicle cargo and generating evaluation data with practicing dermatologists.

Vesera™ is a skincare company. For cosmetic applications, BioThera licenses its technology exclusively to Vesera™ and produces the plant-derived extracellular vesicle material Vesera™ uses. Vesera™ is responsible for its own products, claims and sales.

Through Vesera™'s own channels, which handle the availability and distribution of its products. BioThera does not sell products to consumers, clinics or retailers, and does not ship products.

In Canada, they are cosmetics under the Cosmetic Regulations made under the Food and Drugs Act. Their Health Canada cosmetic notification has been completed, and they can be legally distributed and sold in Canada. There is no separate category for extracellular vesicles in cosmetics; they fall under the same regulations as other cosmetic ingredients. Like all cosmetics, these products are not intended to diagnose, treat, cure, or prevent any disease. Any therapeutic use of extracellular vesicles falls under a different and far more demanding framework, which is why our work on therapeutic applications is research only.

MISEV2023 (Minimal Information for Studies of Extracellular Vesicles) is the global scientific consensus standard published by the International Society for Extracellular Vesicles (ISEV). It defines the minimum characterization data required to credibly report an EV preparation: particle size distribution, concentration, EV-associated protein markers, and absence of contaminants, among other parameters. MISEV2023 matters because without it, no two EV studies or products can be meaningfully compared, it is the shared scientific language the field needs to mature. BioThera's characterization protocols are aligned with MISEV2023. Notably, BioThera's CEO is a named contributor to the MISEV2023 guidelines development process.

The method used to isolate EVs from a biological source fundamentally shapes the final preparation, including its purity, size distribution, surface protein composition, and biological activity. Ultracentrifugation, ultrafiltration, size exclusion chromatography (SEC), and precipitation-based methods all yield preparations with different characteristics, even from the same starting material. BioThera's scientific team has published peer-reviewed research demonstrating how isolation method alters the EV biomolecular corona, the layer of proteins and molecules on the EV surface that mediates its biological interactions with recipient cells. Process transparency is therefore not optional for any credible EV product.

NTA is a core technique for EV characterization. It tracks the Brownian motion of individual nanoparticles in liquid suspension under a laser, giving particle-by-particle size distribution and concentration data rather than population averages. MISEV2023 calls for particle quantification as part of EV characterization, NTA is one of the most widely used methods for it, and we use it on every batch we produce.

Even minor variations in source material, harvest timing, isolation method, processing conditions, or storage can produce EV preparations with meaningfully different biological properties. This is because EVs are not a defined chemical compound, they are a population of biological particles whose composition reflects the dynamic state of the cells that produced them. Most EV preparations in both research and commercial settings show significant lot-to-lot variability, making it difficult to dose reliably or predict efficacy across batches. Addressing this variability through defined process controls and analytical verification at every production run is the core manufacturing challenge BioThera was built to solve.

Every production batch is measured by Nanoparticle Tracking Analysis (NTA) for particle concentration and size distribution. Purity is assessed with the particle-to-protein ratio: a high ratio indicates a preparation enriched for vesicles rather than contaminating protein aggregates or non-vesicular material. Results are documented in a batch-specific Certificate of Analysis, for every batch rather than representative lots. In a market where many EV products do not disclose concentration data at all, routine batch verification is the foundation of manufacturing accountability.

Our EV isolation process is proprietary and patent pending. Our scientific team chose it because, in our assessment, it is among the most scalable approaches available for plant-derived EV isolation, and because it relies on gentle processing steps that avoid mechanical or chemical damage to the vesicles during purification. Isolation method matters: two preparations from the same source isolated by different methods can differ in purity, size distribution, surface proteins and biological activity. Our team has published peer-reviewed research showing how isolation method alters the EV biomolecular corona, the layer of proteins and molecules on the vesicle surface that mediates its interactions with recipient cells. Process documentation is available to qualified partners under an appropriate agreement.

Five criteria every clinician should apply before stocking an EV product. (1) Source: what cell type, tissue, or organism are the EVs derived from? This determines their biological properties and makes products non-interchangeable. (2) Particle concentration: is there a verified particles/mL figure backed by NTA data? (3) Certificate of Analysis: is batch-specific documentation available? (4) Isolation method: is the process disclosed? Method directly affects product composition and quality. (5) Cold-chain integrity: EVs are thermolabile and must be handled and shipped under controlled temperature conditions. Our free EV SELECT GUIDE walks through each criterion in detail.

No. "Exosome" describes a class of biological particles, not a standardized product. EVs from different sources, including different cell types, tissue origins, or biological kingdoms, have fundamentally different molecular payloads and mechanisms of action. This applies even across suppliers claiming the same source: without standardized production processes and equivalent characterization data, no two EV products can be scientifically assumed to be equivalent. The lack of industry-wide standardization is the defining regulatory and scientific challenge in this space. Evaluating each product on its own scientific merits, with data, is the only defensible clinical approach.

Many EV products on the market do not disclose particle concentration, do not provide batch-specific Certificates of Analysis, and use the term "exosome" without the characterization to support it. We work differently: every batch is characterized in line with MISEV2023, particle concentration is measured by NTA, and each batch has its own Certificate of Analysis. Our founder is a named contributor to MISEV2023, the field's consensus standard, and we hold our manufacturing to the characterization, transparency and reproducibility standards of credible EV science.

Yes. Qualified partners can request a representative Certificate of Analysis for our EV material through the request form on our Resources page. It covers particle concentration, size distribution and related characterization data.

A credible EV Certificate of Analysis (CoA) should document at minimum: (1) NTA-verified particle concentration with a stated particles/mL figure, not a range or estimate; (2) particle size distribution, including mean and mode diameter, confirming EV-range particles are the dominant population; (3) purity indicators such as particle-to-protein ratio, confirming the preparation is enriched for vesicles rather than co-isolated protein aggregates; (4) safety panel, including sterility testing and endotoxin/LPS screening to confirm the preparation is safe for topical application; and (5) source and batch traceability, identifying which source material, isolation run, and production date the data corresponds to. Certificates that list only a particle count without methodology, or that apply to a "representative lot" rather than the specific batch, should be treated with caution. BioThera provides batch-specific CoAs to qualified partners; see the EV SELECT GUIDE for a full evaluation framework.

BioThera Solutions is an Ottawa-based biotechnology company building a fully integrated extracellular vesicle platform, from research and intellectual property to manufacturing. Our R&D has produced proprietary, patent-pending technology and the capacity to manufacture at scale. For cosmetic applications, we license our technology exclusively to Vesera™, a skincare company, and produce the EV material it uses. Our research team continues to investigate other applications of the technology, and therapeutic applications are an important focus.

BioThera Solutions is headquartered in Ottawa, Ontario, Canada. Our location provides proximity to Health Canada, a growing life sciences ecosystem, and the clinical and research collaborators central to our work.

Yes. BioThera Solutions is conducting a pre-seed/seed round. For details, please visit our Investors page.

We are building one platform that works across vesicle sources and applications. Our current platform uses plant-derived vesicles; as we grow, our research extends to animal-derived sources, including human stem cell-derived vesicles, for applications where their biology is the better fit. Alongside cosmetic applications, our research team is focused on therapeutic applications of extracellular vesicles. Every application builds on the same manufacturing, characterization and intellectual property foundation.

Our statements are grounded in characterization data, not marketing language. Our work is aligned with MISEV2023, the global consensus standard for EV characterization, and the methods behind that alignment are documented on our Technology page. We do not extrapolate from the broader EV literature to claims about specific materials, and where the evidence is preliminary, we say so.

No. BioThera does not sell products to consumers, and nothing on this website is medical advice. Our work on therapeutic applications is research only: it is not a product, is not offered for sale, and carries no therapeutic claim. For any medical question, please consult a qualified healthcare professional.