How to read a COA, what good numbers look like, and the standards quality clinics publish.
A certificate of analysis is the laboratory's release document for the specific batch of cells you are given. It is the difference between knowing what you received and taking a clinic's word for it.
What a COA should contain
| Field | What good looks like |
|---|---|
| Batch / lot number | Unique, traceable, matches your paperwork |
| Cell type and source | e.g. Umbilical cord-derived MSC, passage number stated |
| Total viable cell count | Stated as an absolute number, not 'high dose' |
| Viability | Typically ≥ 90% fresh, ≥ 80% post-thaw |
| Sterility | Negative for bacterial and fungal growth |
| Mycoplasma | Negative |
| Endotoxin | Below stated limit, with the limit shown |
| Identity markers | CD73, CD90, CD105 positive; CD34, CD45 negative |
| Release date and signature | Named responsible person, dated |
What a quality COA looks like
- A unique batch number that matches the record in your paperwork.
- A measured viability figure for your specific batch, not a typical range.
- Sterility and endotoxin results included, with the limits shown.
- The document shared before treatment, as standard practice.
- The laboratory name, address and an authorised signature on the page.
Quality clinics share the certificate of analysis before you pay the balance — asking for it early is a normal, welcome part of the conversation.
Ask for it in writing at enquiry stage — see the complete patient guide for the full question list.
This is general information only and does not constitute medical advice. Always consult a qualified physician before making healthcare decisions.
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