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02Evidence & QualityWhat we measure, and why

What we measure,
and why.

Anyone can call a material "high quality." We put the numbers on the Certificate of Analysis that ships with every order, and here is exactly what each one tells you.

01The pipelineSource to release

Every line, botanical or human-derived, moves through the same four stages under one release standard.

01 · Source

Named, traceable material

Edible botanicals selected for their actives, or Wharton's-Jelly donors that are consented and screened. The starting material is documented, not generic.

02 · Isolation

Vesicles, isolated cleanly

Extracellular vesicles are isolated and, where it helps stability and transport, lyophilized. The method is consistent batch to batch.

03 · Characterization

Counted, sized, identified

Particle concentration and size by NTA, morphology by TEM, and identity markers confirm what is in the vial before anything ships.

04 · Release

Nothing ships until it passes

Sterility, endotoxin, and mycoplasma testing gate the batch. A Certificate of Analysis records the result and travels with the product.

02The panelSeven tests per batch

Seven tests,
each with a reason.

A particle count alone means little. This is the panel that lets a formulator, a clinic, and a lab trust the same vial.

Mean particle size · NTA
Confirms the material sits in the 30–150 nm range expected of exosomes, measured by Nanoparticle Tracking Analysis rather than estimated.
Particle concentration · NTA
The number of vesicles per millilitre, so dosing and formulation start from a real figure, not a claim.
Morphology · TEM
Transmission electron microscopy shows the cup-shaped vesicle structure directly. NTA counts particles; TEM proves they are vesicles, not debris.
Identity markers · CD9 / CD63 / CD81
The tetraspanin markers expected of exosomes under the MISEV framework, with a negative control, to confirm identity rather than assume it.
Sterility · USP <71>
Confirms no microbial growth in the finished material against a recognized pharmacopeial method.
Endotoxin · LAL
Bacterial endotoxin held below a defined limit, because a low count with a high endotoxin load is not a clean material.
Mycoplasma · qPCR
Screens for the contamination culture-based tests miss, so cell-derived material can be trusted downstream.
03On the recordThe Certificate of Analysis

The Certificate
of Analysis.

Every result above lands on one document that ships with the batch. Request a redacted sample to see the full format.

GainMed
CERTIFICATE OF ANALYSIS
Batch EC-2024-0417
Rev. 1 · illustrative
ExoCell · Human UMSC-derived

Characterization & release

Mean particle sizeNTA
118 nm
Pass
Particle concentrationNTA
2.1 × 10¹¹ /mL
Pass
MorphologyTEM
Cup-shaped
Pass
Identity markersCD9 / CD63 / CD81
Positive
Pass
SterilityUSP <71>
No growth
Pass
EndotoxinLAL
< 0.1 EU/mL
Pass
MycoplasmaqPCR
Not detected
Pass
Released by QARequest a real COA
04Quality systemOur governance

Built under one
quality system.

Characterization only counts if the environment behind it is controlled. Ours is documented, and the certificates are available for review.

ISO 13485Quality management
GMPManufacturing
118+Characterized batches
34+Markets served

Honest by classification

GainMed segments its claims by product class. Cosmetic products are for external use on intact skin and make no disease claims. Research-use materials are for research only, not human or clinical use. There are currently no FDA-approved exosome products, and we say so plainly.

Availability and regulatory status vary by market and are confirmed before dispatch.

Ask for the documentation.

Request a redacted sample COA, a specification sheet, or the full technical dossier for any product.

Request documentation