BioThera Solutions

精准EV护肤, 专为临床医生而备。

一款旗舰产品。毫不妥协的表征。为要求更多的医疗从业者和研究人员而构建。

临床医生和研究人员正在探索的领域

基于细胞外囊泡(EV)和外泌体的护肤品是美容皮肤科增长最快的品类之一。临床医生和研究人员正积极探索EV衍生精华液是否能支持该领域广泛称为下一代抗衰老护肤的应用——涵盖细胞信号支持、皮肤更新和生物活性化合物的深层真皮递送。与传统化妆品精华液递送孤立活性分子不同,EV在磷脂双分子层内携带蛋白质、脂质和核酸的多重有效载荷——许多医疗从业者将其描述为递送护肤活性成分的根本不同方法。跨界EV相互作用的临床前研究不断增加,将这种临床兴趣延伸至植物源配方,引发了关于可扩展性、安全性和标准化的问题,而BioThera Solutions正是为回答这些问题而创立的。

对底层科学感兴趣?探索技术平台
mPDEV (Exosome) Serum — plant-derived extracellular vesicle dermocosmetic serum

BioThera Solutions植物源细胞外囊泡精华液

The mPDEV Serum by BioThera Solutions is a Health Canada-notified cosmetic containing plant-derived extracellular vesicles sourced from Aloe barbadensis, characterized to MISEV2023 standards. It is formulated with an ultra-minimal ingredient list — every component present by design — to preserve the biological activity of the EV payload through formulation and topical application.

精密配制的皮肤美容精华液——BioThera EV生物制造平台的首个商业应用。

临床测试阶段——仅限早期访问

mPDEV (Exosome) Serum目前正与精选皮肤科合作伙伴进行积极的临床测试——尚未开放一般购买。我们正在构建该产品应有的临床证据基础,然后再进行更广泛的部署。加入早期访问名单,一旦诊所访问开放即可获得通知。

Flagship Active Ingredient

Aloe Barbadensis-Derived Extracellular Vesicles

~30 BILLION PARTICLES / mL · pH 5.0 · MISEV2023

Our flagship active is derived from Aloe barbadensis (aloe vera) — one of the most extensively studied botanical ingredients in the world, with a long history of use in skin care across cultures. Its topical safety profile is well-established: eligible for ECOCERT/COSMOS organic certification, and carries virtually no systemic toxicity risk when used topically.

BioThera's proprietary isolation process extracts EVs directly from fresh aloe vera plant material, yielding nanoparticles (30–200 nm) that preserve the plant's bioactive cargo — antioxidant compounds and skin-conditioning molecules — within a stable phospholipid bilayer. At a guaranteed concentration of ~30 billion particles/mL, every application delivers a verified, precisely characterized EV payload.

Particle size30 – 200 nm
Concentration~30B particles / mL
pH5.0
CharacterizationMISEV2023
Allergy riskLow (see note ↓)

Full Formula (INCI)

7 ingredients. Every one intentional — nothing superfluous.

Ingredients / Ingrédients

Aloe Barbadensis-Derived Extracellular Vesicles, Glycerin, Sodium Hyaluronate, Phenoxyethanol, Ethylhexylglycerin, Gluconolactone, Sodium Benzoate, Sodium Phytate, Citric Acid

Paraben-freePhthalate-freeFragrance-freepH 5.0
Listed in descending order of predominance

Keep frozen until ready to use. Once opened, store at 4°C — use within 4 weeks. Do not refreeze.

Formulation Rationale

EVs as a multi-payload delivery system

Proteomics characterization of the mPDEV serum's EV fraction identified a large number of proteins distributed across three functional categories: antioxidant-associated, anti-inflammatory-associated, and wound-healing/regenerative-associated proteins. These protein classes are consistent with the well-documented biological profile of Aloe barbadensis, whose antioxidant, anti-inflammatory, and wound-healing properties have been studied extensively across decades of peer-reviewed literature. The EVs serve as the delivery vehicle for this protein cargo — encapsulated within a phospholipid bilayer that preserves the payload through formulation and application.

Dual-weight hyaluronic acid for layered hydration

We include both high-molecular-weight (HMW) and low-molecular-weight (LMW) Sodium Hyaluronate. HMW HA forms a moisture-retaining film at the skin surface, while LMW HA penetrates deeper layers to support structural hydration and improve the dermal matrix environment — directly synergizing with EV delivery kinetics.

Glycerin as a biocompatibility carrier

Glycerin's hygroscopic properties not only hydrate but maintain the stable aqueous microenvironment that preserves EV membrane integrity during application and absorption. Its universal tolerability makes it ideal for sensitive and post-procedure skin — key patient populations for the mPDEV serum.

Natural preservation without parabens

GSB Geogard Ultra (Gluconolactone + Sodium Benzoate) is a naturally-derived, ECOCERT/COSMOS-certified preservative system. Combined with Euxyl PE 9010 for broad-spectrum coverage, this dual approach ensures microbiological stability across the full shelf life — without the sensitization concerns linked to parabens.

Sodium Phytate for oxidative cargo protection

Plant-derived EVs carry bioactive lipids and proteins susceptible to metal-catalyzed oxidation. Sodium Phytate chelates trace metal ions within the formulation, shielding EV cargo from degradation and preserving active potency throughout the product's shelf life. ECOCERT/COSMOS certified, negligible sensitization risk.

pH 5.0 buffered with Citric Acid for skin compatibility

The formulation is precision-buffered to pH 5.0 — well within the skin's natural acid mantle range (pH 4.5–6.0). Citric Acid serves as the buffering agent: a naturally-occurring α-hydroxy acid widely used in cosmetics, ECOCERT/COSMOS-permitted, and capable of providing tight pH control at the trace concentrations required (<0.1%). This pH supports barrier integrity, minimizes transepidermal water loss, optimizes EV-membrane interaction at the skin surface, and aligns with the native stability window of Sodium Hyaluronate as well as the efficacy range of both preservative systems.

Allergy note: Individuals with a known sensitivity to aloe vera should perform a patch test prior to first use. Allergic contact dermatitis risk is low and consistent with the general aloe vera sensitization rate in the broader population (<1%). All other formulation ingredients carry a very low sensitization profile and are well-tolerated across skin types, including sensitive and compromised skin barriers.

质量文件

代表性CoA可应要求提供

mPDEV(外泌体)精华液的代表性Certificate of Analysis — 涵盖粒子浓度、粒径分布、活性和无菌性 — 可提供给符合条件的合作伙伴和临床医生。

定价

合作伙伴定价

定价作为我们合作伙伴评估流程的一部分进行披露 — 不公开列示。请填写下方表格加入等待名单,我们将在分享商业条款之前评估双方的匹配度。

价格:申请提前访问 — 价格将在发布时公开。

加入早期访问
🚚 仅限加拿大境内配送 — 固定运费 CAD 29.99·30天满意保证 · 未开封产品60天内退货·配送与退货政策

合规状态

The mPDEV Serum by BioThera Solutions is registered with Health Canada under the Cosmetic Notification process — the mandatory regulatory pathway for cosmetic products sold in Canada. BioThera Solutions characterizes its plant-derived EVs to MISEV2023 standards, the global consensus framework co-authored by the company's founder and established by the International Society for Extracellular Vesicles (ISEV).

已完成

Health Canada——化妆品法规(C.R.C., c. 869)

完全符合加拿大消费品安全法(C.R.C., c. 869)下的加拿大化妆品法规。加拿大市场已获授权。

已完成

MISEV2023——表征合规

完全符合国际细胞外囊泡学会(ISEV)发布的细胞外囊泡研究最低信息(MISEV2023)指南——全球标准。

已完成

Leaping Bunny无动物实验认证

有效认证。生产或供应链的任何阶段均无动物实验。

进行中

GMP/ISO合规制造

预期治疗管线扩展,制造工艺正积极向GMP和ISO合规方向发展。

计划中

FDA——FD&C Act / MoCRA合规

配方符合《联邦食品、药品和化妆品法》(FD&C Act,21 U.S.C. § 361)及2022年《化妆品监管现代化法》(MoCRA)的要求。进入美国市场的计划将在未来阶段实施——设施注册和完整的MoCRA合规将在当时追求。

第一个获知。

加入我们的候补名单,当mPDEV (Exosome) Serum上市时,我们会通知您。我们也很乐意了解您是谁——这有助于我们优先考虑适当的访问渠道。

无垃圾邮件。我们只在有意义的信息时才会联系。