全谱系EV平台。 从原料到规格的精密生物制造。
BioThera Solutions operates a full-stack extracellular vesicle (EV, exosome) biomanufacturing platform, from upstream isolation to downstream characterization in line with MISEV2023, designed for consistency, traceability and scale. Our current source is plant-derived, and the platform is built to extend to other sources.
什么是细胞外囊泡（EV/外泌体）？
细胞外囊泡（EV/外泌体）是几乎所有细胞类型作为正常细胞通讯的一部分自然释放的纳米级膜结合颗粒。根据MISEV2023，直径约为30至1000纳米，尽管EV群体本质上是异质性的，高质量制备物将围绕特定的粒径峰值富集，小型EV通常为30–200纳米，此处指小型细胞外囊泡。携带复杂的分子货物，包括蛋白质、脂质、核酸（如miRNA和mRNA）以及生物活性信号分子。
EV作为内源性细胞间信使发挥作用：它们被受体细胞摄取，其货物可以调节基因表达、影响炎症信号并支持细胞修复机制。这种生物活性使EV成为医学和消费者健康领域重要的科学与商业研究领域。
In skin biology specifically, EVs derived from botanical sources have been studied in the peer-reviewed literature for their potential role in supporting antioxidant activity and skin-conditioning properties in keratinocyte and fibroblast populations. Products made with our material are cosmetics, and no drug or therapeutic claims are made.
注："外泌体"这一术语在更广泛的市场中被普遍使用，但在当前ISEV/MISEV2023指南下并不精确，该指南建议将"细胞外囊泡"（EV）作为主要科学描述词，除非细胞内内体来源经过实验确认。BioThera在所有资料中均以"EV"作为主要科学术语。
Phospholipid bilayer
Lipid membrane defining the EV boundary and enabling cellular uptake.
Tetraspanins
MISEV-designated surface markers mediating EV-cell recognition and uptake.
Transmembrane proteins
Cargo loading and cellular targeting determinants embedded in the bilayer.
Biomolecular corona
Adsorbed proteins forming a dynamic outer shell that shapes how the vesicle interacts with cells.
Intraluminal cargo
Proteins, lipids and nucleic acids carried inside the vesicle, including the bioactive classes described below.
EV的组成和电晕结构因来源细胞类型、分离方法和生物学环境而异。
我们的制造方式
BioThera Solutions uses a standardized, closed-loop biomanufacturing workflow, from upstream sourcing and EV isolation to downstream particle characterization, producing extracellular vesicles to MISEV2023-aligned specifications. The process is engineered for batch-to-batch reproducibility, full traceability, and scalability from research-grade to commercial-grade output.
Our EV isolation and purification process is proprietary and patent pending. Process details are not disclosed publicly. What we can confirm:
- Designed for reproducibility and scalability from the ground up
- Every production batch undergoes standardized analytical characterization
- Clinical-line material ships frozen, with cold-chain protocols maintained throughout handling and distribution
- Manufacturing trajectory aligned toward GMP and ISO compliance
我们的核心竞争优势
We know how to produce industrial quantities of characterized EVs at the rigour the field requires. Our biomanufacturing workflow is the infrastructure the EV field has been missing: reproducible, standardized, and engineered from the ground up to be source-flexible, starting with plant-derived EVs and built to support applications well beyond our first.
质量控制框架
Nanoparticle Tracking Analysis (NTA)
Particle concentration and size distribution measured for every batch, a core method for EV characterization under MISEV2023.
Certificate of Analysis (CoA)
Batch-level documentation issued for every production run.
Cold-Chain Handling
Temperature-controlled from manufacturing through delivery. Product ships frozen to ensure EV bioactivity is fully preserved upon arrival.
MISEV2023 Characterization
Characterization in line with the Minimal Information for Studies of Extracellular Vesicles (MISEV2023) guidelines published by ISEV.
Stability, Designed Around Each Product Line.
Extracellular vesicles are biological material. Temperature, water and time all work against them, so how a product is stored and shipped is part of its quality, not an afterthought. We design storage and logistics around the needs of each product line.
Frozen
Clinical line: kept frozen
Our clinical-line material is maintained frozen from production to the clinic, with cold-chain protocols held throughout handling and distribution. Every shipment includes the Certificate of Analysis for the batch in the box.
Lyophilized
Other lines: lyophilized for room-temperature logistics
Where a frozen supply chain is impractical, we lyophilize (freeze-dry) the vesicles. Lyophilization removes nearly all of the water, leaving a dry form that is far easier to store and ship, and markedly more stable at room temperature than a liquid preparation.
How freeze-drying works, in plain terms
01
Freeze
The vesicle preparation is frozen solid, locking its water into ice.
02
Remove the ice
Under a deep vacuum, the ice turns straight into vapour without ever melting, and is drawn away. It is the same principle used for many injectable medicines.
03
Seal it dry
What remains is a dry material, sealed against moisture until it is reconstituted.
Why it works
Most of what degrades a biological product over time needs water: chemical breakdown, microbial growth, and particles clumping together. Remove the water and those processes slow dramatically. Lyophilization is carried out under tightly controlled conditions by our scientific team.
Why Source Matters: Plant and Mammalian EVs
Extracellular vesicles can come from many biological sources, and each suits different applications. Our current platform uses plant-derived vesicles, which bring real advantages in scale and cost. 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.
跨界生物学通讯
The capacity of plant-derived EVs to interact with and influence mammalian cellular processes represents an emerging and scientifically important area of EV research. This cross-kingdom biological communication underpins our first EV source, and informs how we evaluate every application we build on the platform.
Plant-derived: built for scale
Abundant, renewable biomass and no cell culture make production simpler and lower in cost, with no animal or human donor material required.
Plant-derived: a clean starting point
Plant sources reduce the contamination and donor-variability risks of mammalian cell culture, and the long use of botanical actives in cosmetics provides a well-characterized safety baseline for topical use.
Mammalian-derived: human-relevant biology
Vesicles from mammalian cells, including human stem cells, carry signalling molecules shaped by human tissue biology, and they are the most studied source in therapeutic research.
Choosing by application
No single source is best for every use. We match the source to the application, and our manufacturing and characterization expertise carries across sources.
三类载荷。一个囊泡。
Proteomics characterization of BioThera's current plant-derived EV material identified proteins distributed across three functional classes: antioxidant-associated, anti-inflammatory-associated, and wound-healing/regenerative-associated. These payload classes are consistent with the well-documented biological profile of Aloe barbadensis across decades of peer-reviewed literature.
BioThera已通过蛋白质组学分析确认了植物源EV中三种不同的生物活性载荷类别。
抗氧化载荷
通过蛋白质组学确认的抗氧化活性分子，包括植物源酚类化合物和自由基清除剂。这些物质减弱皮肤细胞群体的氧化应激，并支持细胞防御机制。
舒缓皮肤生物活性组分
通过蛋白质组学确认的信号分子，在细胞研究中研究其与角质形成细胞和成纤维细胞群体中舒缓和镇静特性的关联性的化合物。
皮肤更新生物活性组分
通过蛋白质组学确认的生长因子相关分子和miRNA种类，在细胞研究中研究其在支持皮肤细胞更新和护理过程中的作用的化合物。
Bioactive payload characterization conducted by proteomics and in line with MISEV2023 guidelines. No therapeutic claims are made. Products made with our material are cosmetics under Canada's Cosmetic Regulations (C.R.C., c. 869).
One platform. Many applications.
The same isolation and characterization workflow supplies every application built on the platform. See what it supplies, which application areas it serves, and how far each one has actually gone.
See the applications细胞外囊泡与人类皮肤相互作用的当前认知与拟议机制
Current scientific evidence supports EV surface and epidermal interaction as the primary mechanism by which topically applied plant-derived EVs may influence skin biology. BioThera Solutions presents an evidence-stratified model distinguishing well-supported surface interactions from plausible follicular routes, while noting that further research is required to demonstrate passive penetration of intact EV-sized particles (30–1000 nm) across the stratum corneum.
细胞外囊泡被提议通过多种途径与人类皮肤相互作用，每种途径具有不同程度的实验支持。该模型区分了文献中有充分支持的表面和表皮相互作用与合理的毛囊渗透途径。完整EV大小的粒子（30–1000纳米）的跨角质层被动扩散仍是一个需要进一步研究来证明穿越SC渗透的领域。所描绘的任何机制均未经临床确认。
Pathway Evidence Levels
Evidence-stratified pathway model: no mechanism is clinically confirmed. This illustration maps proposed interaction pathways across distinct levels of experimental support. Surface and epidermal interaction (stratum corneum surface, keratinocytes) is well-supported in the botanical EV literature. Follicular penetration via the hair follicle shaft and sebaceous duct is a plausible and increasingly studied route for nanoscale particles. Trans-stratum corneum passive diffusion of intact EV-sized particles (30–1000 nm) remains an active area of investigation; further research is required to demonstrate passive penetration across the SC.
Anatomical accuracy & site-of-effect framing. Layer proportions are calibrated to H&E histological reference standards. The epidermis is rendered at 3× its true relative scale. Vasculature is shown in longitudinal view; hair follicle, sebaceous gland, eccrine sweat gland, and dermal innervation are anatomically positioned. EV opacity attenuates with depth to reflect decreasing penetration confidence. The dermis is marked as the proposed site of biological effect: surface interactions may initiate signalling cascades that propagate to deeper dermal cell populations, independent of whether EVs physically traverse the stratum corneum.