One Platform. Many Applications.

BioThera isolates and characterizes plant-derived extracellular vesicles at manufacturing scale. What those vesicles are formulated into is an application question, not a platform one. Below are the areas the platform is built to serve — and how far each one has actually gone.

Characterized material, documented batch by batch.

Material

Characterized EV bulk

Plant-derived extracellular vesicles isolated at manufacturing scale, counted by Nanoparticle Tracking Analysis and characterized against the MISEV2023 marker framework.

Documentation

Batch-specific CoA

Every batch ships with its own Certificate of Analysis: particle concentration, EV marker panel, and contamination screen. MISEV2023 disclosures available on request.

Logistics

Cold-chain delivery

Shipped directly from the BioThera Solutions facility in Ottawa, Ontario, in cold-chain packaging sized to the destination. No distributor handoff.

How the material is made:Our technology

Where the platform applies — and how far it has gone.

Maturity reflects how far BioThera has taken each area, not what extracellular vesicles are claimed to do in the literature. Areas marked as research directions have no BioThera product and no published timeline.

Commercial

Skincare & dermocosmetics

Topical formulation of characterized plant-derived EVs for professional skin care. Supplied to verified dermatology and aesthetic medicine clinics in Canada under our Vesera™ brand. Not in general distribution.

In evaluation

Clinical dermatology

An active safety and efficacy study is underway with practicing dermatologist partners. Clinics evaluating the material receive the batch-specific Certificate of Analysis behind every shipment.

Research direction

Wound & barrier repair

EV cargo classes associated with wound healing appear in our proteomics data and in the plant-EV literature. We have characterization data; we do not yet have outcome data.

Research direction

Regenerative medicine

The biomanufacturing and characterization requirements of regenerative applications are the ones this platform was engineered against. No BioThera product exists in this space.

Research direction

Drug delivery

EVs are a phospholipid-bilayer delivery vehicle. Whether ours can carry an exogenous payload at specification is an open question we are equipped to answer.

Vesera

Vesera™ — our dermocosmetic brand.

Vesera™ is BioThera’s dermocosmetic brand: plant-derived extracellular vesicles from Aloe barbadensis, formulated for professional skin care. It is a Health Canada-notified cosmetic, characterized to MISEV2023 on every batch. Vesera™ is one application of the platform — not the company.

Standards we manufacture to

Concluído

Health Canada — Regulamentações Cosméticas (C.R.C., c. 869)

Totalmente em conformidade com as Regulamentações Cosméticas do Canadá sob a Lei de Segurança do Produto de Consumo do Canadá (C.R.C., c. 869). Mercado canadense autorizado.

Concluído

MISEV2023 — Caracterização Conforme

Totalmente em conformidade com as diretrizes de Informações Mínimas para Estudos de Vesículas Extracelulares (MISEV2023) — o padrão global publicado pela Sociedade Internacional de Vesículas Extracelulares (ISEV).

Concluído

Certificação Leaping Bunny Livre de Crueldade

Certificação ativa. Sem testes em animais em nenhuma etapa da produção ou cadeia de fornecimento.

Em Andamento

Fabricação Alinhada GMP/ISO

Processo de fabricação em desenvolvimento ativo em direção ao alinhamento com GMP e ISO conforme escalamos nosso portfólio dermocosmético e de skincare à base de EV.

Planejado

FDA — Alinhamento com FD&C Act / MoCRA

A formulação está alinhada com a Lei Federal de Alimentos, Medicamentos e Cosméticos (FD&C Act, 21 U.S.C. § 361) e a Lei de Modernização da Regulamentação de Cosméticos de 2022 (MoCRA). A entrada no mercado dos EUA está planejada para uma fase futura — o registro de instalações e a conformidade completa com MoCRA serão buscados naquele momento.

Seja o Primeiro a Saber.

Junte-se à nossa lista de espera e notificaremos você quando o Vesera™ Serum estiver disponível. Também adoraríamos saber quem você é — isso nos ajuda a priorizar os caminhos de acesso corretos.

Sem spam. Entraremos em contato apenas quando houver algo significativo para compartilhar.

BioThera supplies cosmetic-grade material today. Vesera™ is a cosmetic under Health Canada Cosmetic Regulations and is not intended to diagnose, treat, cure, or prevent any disease. Application areas marked as research directions are not products, are not offered for sale, and carry no therapeutic claim.

Talk to us about supply or co-development.

Whether you need characterized EV material with documentation behind it, or want to explore an application that is not on this page, start with a conversation.

Contact the team