01 · Terminology
Exosomes sit inside the broader extracellular-vesicle field.
Extracellular vesicles are membrane-bound particles released by cells. Current field guidance emphasizes careful terminology and the use of multiple analytical methods when assigning a specific vesicle identity.
That is why the QBio evidence pages use the measured phrase “exosome-sized particles” for particle-count and size reporting, then separately publish selected protein composition.
MISEV2023 guidance ↗02 · Source
The source should be disclosed, not blurred.
A diligence conversation should cover source material, donor eligibility, partner qualifications, processing, and the release standard.
Perinatal sources
Ask how tissue is obtained, how donor eligibility is reviewed, and which infectious-disease screening panel is used.
Adipose or other human sources
Ask the same source, screening, processing, and lot-documentation questions.
Plant-derived particles
Ask whether the word “exosome” is being used precisely and what particle identity methods support the terminology.
03 · Format
Lyophilized and frozen are operational choices, not proof by themselves.
Published research shows that extracellular-vesicle storage is formulation- and method-dependent. A format claim should be supported by product-specific handling instructions and characterization.
QBio uses a lyophilized format and publishes a product-specific reconstitution protocol. Unopened vials ship and store at ambient temperature without dry-ice logistics. After reconstitution, they are refrigerated and used within 72 hours. That does not replace analytical characterization or lot release testing.
Review lyophilization research ↗04 · Buying checklist
Five questions that expose the difference.
- 01Is the composition quantified?
Look for measured values, methods, units, and named laboratories.
- 02Can I see lot-level documentation?
A sample document is useful; a COA tied to the actual lot is better.
- 03Who manufactures it?
Ask for the facility, responsible manufacturer, and release process.
- 04Is sourcing explained?
Partner qualifications, screening, and eligibility should be discussable.
- 05Are claims disciplined?
Cosmetic marketing should not convert ingredient literature or cell-culture observations into promises about people.
Regulatory reality
No FDA-approved exosome products exist.
The FDA has publicly stated that there are currently no FDA-approved exosome products. QBio does not claim otherwise and positions its products as professional-use topical cosmetics.
Read the FDA public safety alert