The exosome supply market has grown quickly, and quality varies enormously between suppliers. For a clinic, the cost of getting this wrong is not just money: it is a treatment offered to a patient under the clinic's own name, backed by a product the clinic cannot fully vouch for. Before adding an exosome product to your protocols, there is a specific set of documentation and standards worth requiring from any supplier, not just the one you end up choosing.

Start with documentation, not marketing

A supplier's website and sales materials describe what they want you to believe about the product. A Certificate of Analysis (CoA) for the specific batch you are purchasing describes what is actually in the vial. Request a CoA before ordering, and confirm that a new one accompanies every batch you receive afterward, not just the first order.

01
Quantified exosome count
A specific, documented number of exosome particles per vial or per millilitre, not a vague reference to "exosome technology" or "millions of exosomes" with no figure attached. If a supplier can't produce this number for a specific batch, they likely haven't measured it.
02
Bioactive profile in pg/mL
Concentrations for the specific growth factors and cytokines present, typically expressed in picograms per millilitre. A list of growth factor names with no concentrations attached tells you what's theoretically possible in the category, not what's actually in your vial.
03
Disclosed, documented tissue source
Umbilical cord (Wharton's jelly), dental pulp, and adipose tissue produce meaningfully different signalling profiles, covered in our comparison of Wharton's jelly and dental pulp. A supplier should tell you which source they use and be able to substantiate it, not just use "stem cell-derived" as an undifferentiated label.
04
Donor screening records
Documentation that donor material was screened for viral and bacterial markers before entering production, and that donors were healthy, full-term, and ethically sourced under proper consent.
05
GMP-compliant manufacturing
Good Manufacturing Practice compliance and a stated cleanroom classification (Class 100, for example) indicate a controlled, repeatable process with batch-to-batch consistency, rather than a one-off production run.
06
Cold chain and logistics
Ask how the product is shipped and stored in transit, what the shelf life is once received, and what happens if a shipment arrives outside the required temperature range. A supplier without a clear answer here is a supplier who hasn't shipped internationally at scale.
07
Patient-facing documentation
Materials you can use for informed consent conversations: what the product is, its tissue source, and mechanism-based language that doesn't overstate guaranteed outcomes. A supplier who can't provide this is leaving your front-desk staff and practitioners to write their own claims, which is a liability exposure.

Red flags worth walking away from

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No tissue source disclosed, or a source that changes depending on who you ask.
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No batch-specific CoA, only a generic spec sheet used for every shipment regardless of batch.
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Pricing far below the category average with no explanation, which is often a sign of under-dosed or unquantified product.
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Reluctance to provide manufacturing or cleanroom details when asked directly.

What this looks like at Hakke

Our Exo-W and Exo-D platforms, the basis for Revival Serum and Scalp Care, are manufactured in Japan under Class 100 cleanroom conditions, with a documented exosome count and a bioactive profile covering growth factors including EGF, HGF, IGFBP-2, and IGFBP-4, measured in pg/mL. We publish this documentation for clinics evaluating us against any other supplier on this list, not just as a sales point but as the standard we'd want a supplier to meet if we were the ones buying.