BioThera Solutions

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

Complete

Health Canada — Cosmetic Regulations (C.R.C., c. 869)

Fully compliant with Canada's Cosmetic Regulations under the Canada Consumer Product Safety Act (C.R.C., c. 869). Canadian market authorized.

Complete

MISEV2023 — Characterization Compliant

Fully compliant with the Minimal Information for Studies of Extracellular Vesicles (MISEV2023) guidelines — the global standard published by the International Society for Extracellular Vesicles (ISEV).

Complete

Leaping Bunny Cruelty-Free Certification

Active certification. No animal testing at any stage of production or supply chain.

In Progress

GMP/ISO-Aligned Manufacturing

Manufacturing process under active development toward GMP and ISO alignment as we scale our dermocosmetic and EV-based skincare portfolio.

Planned

FDA — FD&C Act / MoCRA Alignment

Formulation is aligned with the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 U.S.C. § 361) and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). U.S. market entry is planned for a future phase — facility registration and full MoCRA compliance will be pursued at that time.

Be First.

The Vesera™ Serum is in active clinical evaluation — not yet in general distribution. Join the early access list and we will notify you the moment clinic access opens. Tell us who you are so we can prioritize the right pathway.

No spam. We'll only reach out when there's something meaningful to share.

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