Frequently Asked Questions, BioThera Solutions

Question 1

What are extracellular vesicles (EVs/exosomes)?

Accepted Answer

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.

Question 2

Are all EV/exosome products the same?

Accepted Answer

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.

Question 3

Do EVs from different sources have different biological properties?

Accepted Answer

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.

Question 4

Why are EVs gaining attention in dermatology and regenerative medicine?

Accepted Answer

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.

Question 5

Can extracellular vesicles actually support skin regeneration?

Accepted Answer

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.

Question 6

Why are plant-derived EVs used in skincare?

Accepted Answer

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.

Question 7

How do plant-derived EVs interact with the skin?

Accepted Answer

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.

Question 8

What is the mPDEV (Exosome) Serum?

Accepted Answer

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.

Question 9

What is the source of the EVs in the mPDEV Serum?

Accepted Answer

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.

Question 10

What bioactive cargo does the mPDEV Serum contain?

Accepted Answer

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.

Question 11

What is the particle concentration and how is it verified?

Accepted Answer

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.

Question 12

Is the mPDEV Serum cruelty-free?

Accepted Answer

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.

Question 13

Is the mPDEV Serum approved by Health Canada, and how does BioThera ensure regulatory compliance and product safety?

Accepted Answer

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.

Question 14

When will the mPDEV Serum be broadly available?

Accepted Answer

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.

Question 15

Are plant-derived EVs regulated differently from synthetic cosmetic ingredients?

Accepted Answer

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.

Question 16

What is MISEV2023 and why does it matter?

Accepted Answer

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.

Question 17

Why does isolation method affect EV product quality?

Accepted Answer

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.

Question 18

What is Nanoparticle Tracking Analysis (NTA)?

Accepted Answer

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.

Question 19

Why is batch-to-batch consistency so difficult to achieve in EV manufacturing?

Accepted Answer

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.

Question 20

How does BioThera verify EV concentration and purity in every batch?

Accepted Answer

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.

Question 21

What isolation method does BioThera use to produce the mPDEV Serum?

Accepted Answer

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.

Question 22

What should I look for when evaluating any EV/exosome product?

Accepted Answer

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.

Question 23

Can I assume two EV products are equivalent if they're both called "exosomes"?

Accepted Answer

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.

Question 24

How is BioThera different from other EV brands in the market?

Accepted Answer

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.

Question 25

Can I request a Certificate of Analysis for the mPDEV Serum?

Accepted Answer

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.

Question 26

How does the mPDEV Serum compare to other premium anti-aging serums?

Accepted Answer

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.

Question 27

What should a credible EV Certificate of Analysis include?

Accepted Answer

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.

Question 28

What does BioThera Solutions do?

Accepted Answer

BioThera Solutions is an Ottawa-based biomanufacturing company. We are not a dermatology brand. We build scalable, standardized infrastructure for the manufacturing of extracellular vesicles, focused on solving the production and quality bottlenecks that have held the EV field back from broader clinical and 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 research needed to build a credible evidence base. The longer-term vision is to expand the platform across regenerative medicine, drug delivery, and immuno-oncotherapeutic applications of EVs.

Question 29

Where is BioThera Solutions located?

Accepted Answer

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.

Question 30

Is BioThera Solutions raising investment?

Accepted Answer

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

Question 31

What are BioThera's plans beyond dermocosmetics?

Accepted Answer

Dermocosmetics is BioThera's entry point, a regulatory-efficient, commercially viable market that allows us to demonstrate manufacturing capability and generate real-world data while building the platform. Our roadmap includes expansion into regenerative medicine (EV-based wound healing and tissue regeneration), drug delivery (EVs as next-generation delivery vehicles for small molecules and biologics), and immuno-oncotherapeutic applications, where engineered or naturally cargo-loaded EVs are being investigated as a modality for activating anti-tumour immune responses and delivering oncology-relevant payloads. The manufacturing infrastructure and IP position we build today are the foundation for all of these applications.

Question 32

How does BioThera ensure its product claims are accurate and science-grounded?

Accepted Answer

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.

Question 33

Is the mPDEV Serum a medical-grade or skin regeneration serum?

Accepted Answer

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.

EV와 엑소좀에 대한 질문, 직접 답변드립니다.

세포외 소포(EV/엑소좀)란 무엇입니까?

모든 EV/엑소좀 제품은 같습니까?

서로 다른 출처의 EV는 다른 생물학적 특성을 가집니까?

EV가 피부과학과 재생의학에서 주목받는 이유는 무엇입니까?

세포외 소포가 정말로 피부 재생을 지원할 수 있습니까?

식물 유래 EV가 스킨케어에 사용되는 이유는 무엇입니까?

식물 유래 EV는 피부와 어떻게 상호작용합니까?

mPDEV(엑소좀) 세럼이란 무엇입니까?

mPDEV 세럼의 EV 출처는 무엇입니까?

mPDEV 세럼은 어떤 생리활성 화물을 함유합니까?

입자 농도는 어떻게 되며, 어떻게 검증됩니까?

mPDEV 세럼은 동물실험을 하지 않습니까?

mPDEV 세럼은 Health Canada의 승인을 받았으며, BioThera는 어떻게 규제 준수와 제품 안전성을 보장합니까?

mPDEV 세럼은 언제 광범위하게 이용 가능해집니까?

식물 유래 EV는 합성 화장품 성분과 다르게 규제됩니까?

MISEV2023이란 무엇이며, 왜 중요합니까?

왜 분리 방법이 EV 제품 품질에 영향을 미칩니까?

Nanoparticle Tracking Analysis(NTA)란 무엇입니까?

EV 제조에서 배치 간 일관성이 그토록 달성하기 어려운 이유는 무엇입니까?

BioThera는 모든 배치에서 EV 농도와 순도를 어떻게 검증합니까?

BioThera는 mPDEV 세럼을 생산하기 위해 어떤 분리 방법을 사용합니까?

EV/엑소좀 제품을 평가할 때 무엇을 살펴봐야 합니까?

두 EV 제품이 모두 "엑소좀"이라 불리면 동등하다고 가정해도 됩니까?

BioThera는 시장의 다른 EV 브랜드와 어떻게 다릅니까?

mPDEV 세럼의 분석증명서를 요청할 수 있습니까?

mPDEV 세럼은 다른 프리미엄 안티에이징 세럼과 어떻게 비교됩니까?

신뢰할 수 있는 EV 분석증명서에는 무엇이 포함되어야 합니까?

BioThera Solutions는 무엇을 합니까?

BioThera Solutions는 어디에 위치해 있습니까?

BioThera Solutions는 투자를 모집 중입니까?

BioThera의 더모코스메틱을 넘어선 계획은 무엇입니까?

BioThera는 자사 제품 주장이 정확하고 과학적으로 뒷받침되도록 어떻게 보장합니까?

mPDEV 세럼은 의료 등급 또는 피부 재생 세럼입니까?

과학적 대화를 환영합니다.