精密バイオ製造。 原料から仕様まで。
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.
細胞外小胞（EV/エクソソーム）とは何ですか？
細胞外小胞（EV/エクソソーム）は、通常の細胞間通信の一部として、ほぼすべての細胞タイプから自然に放出されるナノスケールの膜結合粒子です。MISEV2023によれば、直径は約30〜1000 nmの範囲にあります。ただし、EV集団は本質的に不均一であり、高品質な調製物は定義されたサイズのピーク（小型EV（スモールEV）を指し、通常30〜200 nmのピークに集中します。タンパク質、脂質、核酸（miRNAおよびmRNAを含む）、生理活性シグナル分子を含む複合分子カーゴを運搬します。
EVは内在性の細胞間メッセンジャーとして機能します：受容細胞に取り込まれ、そのカーゴが遺伝子発現を調節し、炎症シグナルに影響を与え、細胞修復メカニズムをサポートします。この生物学的活性により、EVは医学と消費者健康の分野で相当な科学的・商業的関心の領域となっています。
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：「エクソソーム」という用語は広い市場で一般的に使用されていますが、細胞内エンドソーム起源が実験的に確認されない限り、「細胞外小胞」（EV）を主要な科学的記述子として推奨する現在のISEV/MISEV2023ガイドラインでは正確ではありません。BioTheraはすべての資料でEVを主要な科学的用語として使用しています。
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組成とコロナ構造は、ソース細胞の種類、単離方法、生物学的環境によって異なります。
当社の製造アプローチ
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
当社のコア競争優位
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.
品質管理フレームワーク
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.
界（かい）を超えた生物学的コミュニケーション
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.
三つのペイロード分類。一つの小胞。
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は、プロテオミクス分析によって確認された植物由来のEVにおける三つの異なる生理活性ペイロード分類を特定しました。
抗酸化ペイロード
プロテオミクスによって確認された抗酸化活性分子、植物由来のフェノール化合物とフリーラジカル消去剤を含む。これらは皮膚細胞集団における酸化ストレスを弱め、細胞防御メカニズムをサポートします。
皮膚をなだめる生理活性フラクション
プロテオミクスによって確認されたシグナル分子、ケラチノサイトと線維芽細胞集団における皮膚をなだめ鎮静させる特性との関連について細胞ベース研究で研究された化合物。
皮膚再生生理活性フラクション
プロテオミクスによって確認された成長因子関連分子とmiRNA種、皮膚細胞の再生とコンディショニングプロセスのサポートにおける役割について細胞ベース研究で研究された化合物。
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細胞外小胞と人間の皮膚の相互作用に関する現在の理解と提案されたメカニズム
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.
細胞外小胞は複数の経路を通じて人間の皮膚と相互作用することが提案されており、それぞれ異なるレベルの実験的根拠があります。このモデルは、十分に文献で支持された表面および表皮の相互作用と、もっともらしい毛包経路を区別します。EV サイズの粒子（30〜1000 nm）の経角質層受動拡散は、角質層を越える受動的浸透を実証するためにさらなる研究が必要な領域です。描写されているメカニズムは臨床的に確認されていません。
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.