Measured. Documented. Released.
The tests behind every batch, and the paperwork that proves them.
Size & shape
NTA and DLS for size and concentration (30–200 nm); TEM and SEM for morphology.
Identity
Protein content, markers and RNA integrity confirm what the material is.
Release screen
Sterility, endotoxin, mycoplasma, microbial load, aflatoxin and pesticides.
Documentation
COA, MSDS and an analytical summary accompany supply.
Seven gates before a vial leaves.
Receipt & identity
Isolation
Size & concentration
Morphology
Safety screen
Document review
Release
Orthogonal methods, one picture.
No single measurement proves identity, so methods are combined to cover each other’s blind spots.
| Test | Question | Paired against |
|---|---|---|
| NTA | How many particles, and how big? | Cannot tell vesicles from similar-sized particles → electron microscopy and protein data |
| DLS · zeta | Mean size, polydispersity, surface charge | Biased by large particles → NTA |
| TEM · SEM | Do they look like vesicles? Real diameters? | Small sample → ensemble methods |
| Protein · markers | Purity and identity | Markers are source-dependent → source-appropriate panels |
| RNA integrity | Is the cargo intact? | Extraction bias → standardised protocol |
| Sterility · endotoxin · mycoplasma | Safe to handle and formulate? | Method suitability confirmed per matrix |
Research and cosmetic grade, said plainly.
Exosome products intended to treat disease in humans are regulated as drugs or biologics; the US FDA states that none are currently approved. EXOMIE supplies research- and cosmetic-grade materials and finished products, documents them to specification, and makes no diagnostic, treatment or cure claims.
- Characterisation designed around the MISEV2023 principle of orthogonal methods
- Identity, purity, potency and safety framed as four questions answered with data
- Method-tagged results on every Certificate of Analysis
- Clear grade labelling: research, cosmetic or GMP-aligned
Real certificates, real numbers.
Signed Certificates of Analysis for three production batches (September 2025): 5 mL, filter-sterilised through 0.2 µm, expiry August 2026.
Protein by Bradford (µg/mL); by specification 1 µg ≈ 1 billion EVs, so figures read as billions of EVs per mL. Specification: ≥ 2 µg/mL.
| Test | Specification | Rose | Ginger | Papaya |
|---|---|---|---|---|
| Appearance | Transparent clear liquid | Complies | Complies | Complies |
| pH | 5.0 – 6.0 | 5.5 | 5.17 | 5.34 |
| Protein (Bradford) | ≥ 2 µg/mL | 2.62 | 2.13 | 2.09 |
| Particle size (median) | 30 – 200 nm | In range | In range | In range |
| Morphology (SEM) | Spherical, cup shape | Complies | Complies | Complies |
| Total aerobic count | ≤ 10⁴ CFU/g | Absent | Absent | Absent |
| Yeast & mould | ≤ 10² CFU/g | < 1 | < 1 | < 1 |
| E. coli · Salmonella | Absent in 1 g · 10 g | Absent | Absent | Absent |
| Pb · Cd · Hg (ppm) | ≤ 5 · 0.3 · 0.1 | <0.05 · <0.01 · BLQ 0.02 | same | same |
| As · Cr (ppm) | ≤ 1.5 · ≤ 2 | <0.052 · <0.1 | <0.052 · <0.1 | <0.050 · <0.1 |
| Aflatoxin B1 | ≤ 2 ppb | Complies | Complies | Complies |
How we test and release.
Which methods size the vesicles?
Nanoparticle tracking analysis and dynamic light scattering for size distribution and concentration, confirmed by TEM and SEM imaging.
What safety tests precede release?
Sterility, endotoxin (where applicable), mycoplasma, microbial load, and aflatoxin/pesticide-residue screening for botanicals, plus heavy-metal limits.
What ships with a batch?
A Certificate of Analysis and Safety Data Sheet, with an analytical summary on request.
How should material be stored?
Follow the COA and label. As a general principle for biological ingredients: keep cold as instructed, protect from light, avoid repeated freeze–thaw.
Request a documentation pack with your quote.
Research question, bulk requirement or a product for your brand — we’ll route it to the right team and reply with a clear next step.