Plataforma de EV de Espectro Completo. Biofabricação de Precisão da Fonte à Especificação.
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.
O Que São Vesículas Extracelulares (EV/Exossomos)?
Vesículas extracelulares (EV/exossomos) são partículas ligadas à membrana em nanoescala, naturalmente liberadas por praticamente todos os tipos celulares como parte da comunicação celular normal. Segundo o MISEV2023, variam de aproximadamente 30 a 1000 nm em diâmetro, embora as populações de EV sejam inerentemente heterogêneas, e uma preparação de alta qualidade se agrupará em torno de um pico de tamanho definido, tipicamente 30–200 nm, referindo-se às pequenas EVs. Carregam uma carga molecular complexa, incluindo proteínas, lipídios, ácidos nucleicos (como miRNA e mRNA) e moléculas de sinalização bioativas.
Os EVs funcionam como mensageiros intercelulares endógenos: são captados por células receptoras, onde sua carga pode modular a expressão gênica, influenciar a sinalização inflamatória e apoiar mecanismos de reparo celular. Esta atividade biológica torna os EVs uma área de interesse científico e comercial substancial em medicina e saúde do consumidor.
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.
Nota: O termo "exossomo" é coloquialmente utilizado no mercado mais amplo, mas não é preciso sob as diretrizes ISEV/MISEV2023 atuais, que recomendam "vesícula extracelular" (EV) como o principal descritor científico, a menos que a origem endossomal intracelular seja confirmada experimentalmente. A BioThera usa "EV" como seu principal termo científico em todos os materiais.
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.
A composição dos EVs e a estrutura da coroa variam conforme o tipo de célula fonte, método de isolamento e ambiente biológico.
Nossa Abordagem de Fabricação
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
Nossa Vantagem Competitiva Central
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.
Estrutura de Controle de Qualidade
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.
Comunicação Biológica Entre Reinos
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.
Três Classes de Carga. Um Vesículo.
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.
A BioThera identificou três classes distintas de carga bioativa em nossos EVs de origem vegetal, confirmadas por análise proteômica.
Carga Antioxidante
Moléculas com atividade antioxidante, incluindo compostos fenólicos de origem vegetal e sequestradores de radicais livres, confirmadas por proteômica. Estas atenuam o estresse oxidativo em populações de células da pele e apoiam mecanismos de defesa celular.
Fração Bioativa Calmante para a Pele
Moléculas de sinalização confirmadas por proteômica, compostos estudados em pesquisas com culturas celulares pela sua associação com propriedades calmantes e tranquilizantes em populações de queratinócitos e fibroblastos.
Fração Bioativa de Renovação Cutânea
Moléculas associadas a fatores de crescimento e espécies de miRNA confirmadas por proteômica, compostos estudados em pesquisas com culturas celulares pelo seu papel no suporte à renovação de células cutâneas e aos processos de condicionamento.
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 applicationsCompreensão atual e mecanismos propostos de interação das EVs com a pele humana
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.
Propõe-se que as vesículas extracelulares interajam com a pele humana por meio de múltiplas vias, cada uma com um nível distinto de suporte experimental. Este modelo distingue as interações de superfície e epidérmicas bem documentadas da penetração folicular plausível. A difusão passiva trans-estrato córneo de partículas EV intactas (30–1000 nm) permanece uma área onde pesquisas adicionais são necessárias para demonstrar a penetração através do SC. Nenhum mecanismo representado é clinicamente confirmado.
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.