Why documentation matters more than the product name
Extracellular vesicle and exosome products are sold under a range of commercial names. A name on its own does not confirm source, isolation method, particle size, concentration, or marker data. MISEV2023, the consensus reporting framework maintained by the International Society for Extracellular Vesicles, sets out the categories of information a supplier should be able to provide regardless of what the product is called.
Requesting the same categories of documentation from every supplier lets a buyer compare answers directly, rather than relying on the product name or marketing description.
What to request
Ask each supplier to provide the following for the specific lot under consideration, not just general product literature.
- Source cell or tissue used for the preparation
- Isolation method (for example, ultracentrifugation, tangential flow filtration, or size-exclusion chromatography)
- Particle size distribution and concentration data, and the analytical method used to generate it (such as nanoparticle tracking analysis)
- Marker panel used to characterize the preparation (such as ELISA or SP-IRIS) and which markers were tested
- Any evidence offered in support of an 'exosome' classification specifically, as distinct from a general extracellular vesicle classification
Regulatory posture applies regardless of terminology
FDA states there are no FDA-approved exosome products. Such products are generally regulated as biologic drugs under section 351 of the Public Health Service Act. Purchase and clinical-use decisions belong to the physician with their own regulatory counsel.
This holds regardless of the specific name a supplier uses for a preparation. A buyer's documentation request should focus on the underlying characterization data, not the label.
Using this checklist internally
Keep a record of what each supplier provided against this checklist, and note any categories left unanswered. This supports internal procurement records and gives a medical director a clear starting point when reviewing a product.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Does a supplier need to use the word 'exosome' correctly before we buy from them?+
Accurate terminology is one part of a documentation review. Confirm the underlying source, isolation method, and characterization data regardless of which term the supplier uses.
What if a supplier cannot provide particle size and concentration data?+
That is useful information for a procurement decision in its own right, independent of any other factor.
Does this checklist apply to cord blood-derived and amniotic-fluid-derived preparations alike?+
Yes. The same reporting categories apply regardless of the source tissue or fluid.
Who makes the final decision on whether to purchase or use a given EV or exosome product?+
The licensed physician, working with their own regulatory counsel.