정밀 바이오제조. 원료에서 사양까지.
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.
세포외 소포(EV/엑소좀)란 무엇입니까?
세포외 소포(EV/엑소좀)는 정상적인 세포 통신의 일부로 거의 모든 세포 유형에서 자연적으로 방출되는 나노 규모의 막 결합 입자입니다. MISEV2023에 따르면 직경은 약 30~1000 nm 범위입니다, 다만 EV 집단은 본질적으로 이질적이며, 고품질 제제는 정의된 크기 정점(소형 EV, 즉 작은 세포외 소포, 를 지칭하며, 일반적으로 30~200 nm를 중심으로 분포합니다. 단백질, 지질, 핵산(miRNA 및 mRNA 포함), 생리활성 신호 분자를 포함한 복합 분자 화물을 운반합니다.
EV는 내인성 세포간 메신저로 기능합니다: 수용 세포에 흡수되어 유전자 발현을 조절하고, 염증 신호에 영향을 미치며, 세포 수복 메커니즘을 지원할 수 있습니다. 이 생물학적 활성으로 인해 EV는 의학과 소비자 건강 분야에서 상당한 과학적, 상업적 관심의 영역이 되었습니다.
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.
참고: "엑소좀"이라는 용어는 광범위한 시장에서 일반적으로 사용되지만 현재 ISEV/MISEV2023 지침에서는 정확하지 않으며, 세포 내 엔도솜 기원이 실험적으로 확인되지 않는 한 "세포외 소포"(EV)를 기본 과학적 기술어로 권장합니다. BioThera는 모든 자료에서 "EV"를 기본 과학적 용어로 사용합니다.
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 구성 및 코로나 구조는 원천 세포 유형, 분리 방법, 생물학적 환경에 따라 다릅니다.
저희의 제조 방식
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
저희의 핵심 경쟁 우위
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.
품질 관리 프레임워크
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.
계(界) 간 생물학적 통신
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.
세 가지 페이로드 분류. 하나의 소포.
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.
BioThera는 프로테오믹스 분석으로 확인된 식물 유래 EV에서 세 가지 고유한 생리활성 페이로드 분류를 확인했습니다.
항산화 페이로드
프로테오믹스로 확인된 항산화 활성 분자, 식물 유래 페놀 화합물 및 자유 라디칼 제거제 포함. 이들은 피부 세포 집단의 산화 스트레스를 약화시키고 세포 방어 메커니즘을 지원합니다.
피부 진정 생리활성 분획
프로테오믹스로 확인된 신호 분자, 각질 세포 및 섬유아세포 집단에서 피부 진정 및 완화 특성과의 관련성에 대해 세포 기반 연구에서 연구된 화합물.
피부 재생 생리활성 분획
프로테오믹스로 확인된 성장 인자 관련 분자 및 miRNA 종, 피부 세포 재생 및 컨디셔닝 과정을 지원하는 역할에 대해 세포 기반 연구에서 연구된 화합물.
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 applications세포외 소포와 인간 피부 상호작용에 대한 현재 이해 및 제안된 메커니즘
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.
세포외 소포는 여러 경로를 통해 인간 피부와 상호작용하는 것으로 제안되며, 각 경로는 서로 다른 수준의 실험적 지원을 받습니다. 이 모델은 문헌에서 잘 지지되는 표면 및 표피 상호작용과 그럴듯한 모낭 경로를 구별합니다. EV 크기의 온전한 입자(30–1000 nm)의 각질층 수동 확산은 SC를 통한 수동 침투를 입증하기 위해 추가 연구가 필요한 분야입니다. 묘사된 메커니즘은 임상적으로 확인되지 않았습니다.
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.