Your Questions About EVs and Exosomes, Answered Directly.

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 supports the role of EVs in activating pathways associated with skin regeneration, including collagen synthesis, keratinocyte migration, extracellular matrix remodelling, and attenuation of inflammatory signalling. These are the same pathways targeted by leading medical-grade anti-aging interventions. The mPDEV Serum delivers a characterized payload of antioxidant, anti-inflammatory, and regenerative signalling molecules at a verified concentration of 30 billion particles per mL, and it is currently in active dermatologist-led clinical evaluation under Health Canada's cosmetic regulatory framework.

Plant-derived EVs are BioThera's current commercial entry point for three substantiated reasons. (1) Scalability and cost-efficiency: botanical biomass is a renewable, high-yield EV source that supports consistent large-scale production without the ethical or logistical constraints of human- or animal-derived material. (2) Bioactive cargo relevance: plant-derived EVs carry confirmed payloads of antioxidant compounds, anti-inflammatory signalling molecules, and growth factor-associated proteins, as verified in BioThera's proteomics characterization data. (3) Regulatory and ethical simplicity: plant-derived sourcing avoids the complex donor screening, biosafety testing, and ethical review requirements that accompany human biological material. BioThera's platform is designed to span all EV modalities over time; plant-derived EVs represent a strategically sound, scientifically defensible starting point, not a ceiling.

How plant-derived EVs interact with skin is currently a topic of investigation, and BioThera's position reflects the current evidence base honestly rather than overstating it. The skin's outermost layer, the stratum corneum, is a tightly organized lipid-rich barrier, and the question of how nanoparticles in the size range of intact EVs traverse or interact with that barrier under realistic topical conditions is an active area of research across the EV field. The pathways under study include surface and superficial epidermal interactions, where EVs deliver their bioactive 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. The biological signalling effects supported by the research literature are driven by the bioactive payload EVs deliver at the skin interface, and our focus is on characterizing that payload and generating clinical evaluation data with dermatology partners. This framing is consistent with how the same topic is presented on our Technology page.

The mPDEV (Exosome) Serum is BioThera Solutions' first commercial product, a dermocosmetic serum formulated with medicinal plant-derived extracellular vesicles. It is manufactured to a guaranteed minimum of 30 billion particles per millilitre and supplied in a 6.75 mL tube. The product is fully characterized: particle size distribution, concentration (verified by NTA), source, and bioactive payload are all documented per batch.

The EVs in the mPDEV Serum are isolated from medicinal plant sources (botanical biomass), a deliberately chosen starting point that is cost-effective, sustainable, and ethically straightforward. Plant-derived EVs carry biologically relevant cargo confirmed by proteomics: antioxidant-active molecules and compounds associated with skin-soothing and conditioning properties. No animal testing occurs at any stage of mPDEV Serum production.

BioThera has identified three distinct bioactive payload classes in our plant-derived EVs, confirmed by proteomics. (1) Antioxidant fraction: plant-derived phenolic compounds and free radical scavengers associated with antioxidant activity in skin cell populations. (2) Skin-soothing fraction: signalling molecules studied in cell-based research for their association with calming and conditioning properties. (3) Skin-renewal fraction: growth factor-associated molecules and miRNA species studied in cell-based research for their role in supporting skin cell renewal.

The mPDEV Serum is guaranteed at a minimum of 30 billion particles per millilitre (30 × 10⁹ particles/mL) per 6.75 mL tube. This is verified by Nanoparticle Tracking Analysis (NTA), the gold-standard method for EV characterization, and supported by a batch-specific Certificate of Analysis. Particle concentration is one of the most critical quality benchmarks for any EV product, and one that many brands in the market do not disclose.

Yes. The mPDEV Serum holds active Leaping Bunny Cruelty-Free Certification. The current production chain is entirely plant-derived, with no animal testing at any stage. BioThera is committed to maintaining cruelty-free standards across all current and future product lines as the platform expands.

The mPDEV Serum is registered with Health Canada under the Cosmetic Notification process, the required regulatory pathway for cosmetic products sold in Canada. Notification is complete and current, and the product falls under Health Canada's Cosmetic Regulations. On the safety side, every production batch undergoes a full quality panel including sterility testing, endotoxin screening, and viability markers, all documented in a batch-specific Certificate of Analysis. Our manufacturing protocols are informed by MISEV2023 characterization standards, which substantially exceed what is required for most cosmetic products. BioThera's standard is not the regulatory minimum, it is scientific credibility.

The mPDEV Serum is currently in an active research phase. We are working with selected dermatology partners to build the clinical evidence base the product deserves before broader deployment. Clinicians and interested parties can join our waitlist to be notified when access opens.

In Canada, plant-derived EVs used as cosmetic ingredients are regulated under Health Canada's Cosmetic Regulations, the same framework that governs all cosmetic actives. There is no EV-specific regulatory category in Canada at this time. The mPDEV Serum is registered via Health Canada's Cosmetic Notification process and operates within this cosmetic product category. What distinguishes BioThera's approach is that our manufacturing and characterization standards are held to a substantially higher level of rigour than most cosmetic products require, informed by pharmaceutical-grade quality thinking and MISEV2023 scientific standards.

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 the gold-standard technique for EV characterization. It tracks the Brownian motion of individual nanoparticles in liquid suspension under a laser, providing particle-by-particle size distribution and concentration data, not population averages. NTA is required by MISEV2023 for rigorous EV characterization and is how BioThera verifies the guaranteed 30 billion particles/mL specification in every batch of the mPDEV Serum.

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 of the mPDEV Serum is verified using Nanoparticle Tracking Analysis (NTA), the gold-standard characterization method under MISEV2023, to confirm a minimum of 30 billion particles per millilitre. Purity is assessed using the particle-to-protein ratio: a high ratio indicates a preparation enriched for EVs rather than contaminating protein aggregates or non-vesicular material. Results are documented in a batch-specific Certificate of Analysis. This is the verification standard BioThera applies to every batch, not just representative lots. In a market where most EV brands do not disclose concentration data at all, routine batch verification is the foundation of manufacturing accountability.

BioThera's EV isolation process is proprietary, with ongoing IP protection. The method has been chosen by our scientific team 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 because it fundamentally shapes the final EV preparation: two preparations from the same source isolated by different methods will have different purity profiles, size distributions, surface protein compositions, and biological activities. 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. For qualified manufacturing partners and clinical researchers, process transparency documentation is available upon request and disclosed under 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 skincare brands cannot disclose particle concentration, do not provide batch-specific Certificates of Analysis, and use the term "exosome" without adequate characterization to support it. BioThera operates differently: scientifically rigorous characterization, guaranteed particle concentrations verified by NTA, batch-specific CoAs, Health Canada Cosmetic Notification, Leaping Bunny certification, and an active safety and efficacy study with practicing dermatologist partners. Our position is not against the cosmetics industry. It is that an elite cosmetic product should also meet the scientific standards of the EV science field, and we hold ourselves to both: the formulation, sensory, and regulatory standards expected of a premium cosmetic, and the characterization, transparency, and reproducibility standards expected of credible EV science.

Yes. BioThera provides batch-specific Certificates of Analysis for the mPDEV Serum upon request, including particle size distribution, NTA-verified concentration, and relevant characterization data. Submit a request through our contact page at biotherasolutions.com/contact.

The mPDEV Serum belongs to a different category than conventional skincare serums. Most premium skincare products, including leading peptide, retinoid, and vitamin C formulations, rely on synthetic active ingredients that work at the surface chemistry level. Plant-derived EVs operate through a fundamentally different mechanism: biological nanoparticles carrying characterized bioactive cargo that interact with skin cells. What distinguishes the mPDEV Serum from other EV/exosome products on the market is manufacturing accountability: verified particle concentrations (30 billion particles per mL by NTA), rigorous batch-specific characterization, Certificates of Analysis, and an active safety and efficacy study with practicing dermatologist partners. In a category where many brands cannot substantiate their particle counts, this level of scientific transparency is the clinical-grade differentiator.

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 clinical partners, see the EV SELECT GUIDE for a full evaluation framework.

BioThera Solutions is an Ottawa-based biomanufacturing company. We are not a generic dermatology brand. We build scalable, standardized infrastructure for the manufacturing of plant-derived extracellular vesicles, focused on solving the production and quality bottlenecks that have held the EV skincare category back from credible commercial use. Our first commercial application is the mPDEV (Exosome) Serum, a medicinal plant-derived EV dermocosmetic, which serves as our commercial and scientific validation platform while we conduct the clinical research needed to build a credible evidence base. The longer-term vision is to scale that platform into a broader portfolio of dermocosmetic and EV-based skincare applications.

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.

BioThera is building the plant-derived EV biomanufacturing platform that the dermocosmetic and EV-based skincare category requires. The mPDEV (Exosome) Serum is our commercial validation point. The longer-term plan is to scale the same manufacturing infrastructure, characterization rigour, and clinical evidence base into a broader portfolio of dermocosmetic and EV-based skincare applications — built to the standards dermatologists and regulators expect. Every application we bring forward sits on top of the platform, IP position, and clinical data we are establishing today.

BioThera's product claims are grounded in characterization data, not marketing language. Our work is aligned with MISEV2023, the global scientific consensus standard for EV characterization, and the methods, data, and reasoning behind that alignment are documented openly on our Technology page. We do not extrapolate from the broader EV literature to claims about our specific product; every claim we make about the mPDEV Serum is backed by the data we generate on it. Scientific transparency is the standard we hold ourselves to.

The mPDEV Serum is classified and sold as a cosmetic product under Health Canada's Cosmetic Regulations. What distinguishes it is manufacturing rigour: NTA-verified particle concentration, batch-specific Certificates of Analysis, and an active safety and efficacy study with practicing dermatologist partners. Its manufacturing standards substantially exceed what most cosmetic products require. Clinicians looking for an EV skincare product they can evaluate on actual data, document with a CoA, and stand behind scientifically will find the mPDEV Serum is built to that standard.