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StemCell Longevita

Laboratory documents

How to read a Certificate of Analysis for a cell therapy product

A Certificate of Analysis is the batch's report card: identity, count, viability, sterility, mycoplasma, endotoxin, and the date each test was run. Here is how to read one line by line.

Medically reviewed by:
Prof. Dr. Erdal Karaöz Team
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The short answer

A usable CoA names the batch, states each test performed, the method used, the specification, the measured result and the release decision, and it is signed and dated by a named person. If any of those five columns is missing — especially the method and the specification — the number in the results column cannot be interpreted. Ask for the CoA for your own batch, not a sample document from the website.

How to read one, line by line

These steps work at any clinic, anywhere. Nothing here depends on choosing us.

  1. Find the batch or lot identifier and check it matches the product you are actually receiving.
  2. Check identity: for MSCs, surface-marker expression (typically CD73, CD90, CD105 positive; CD34, CD45, HLA-DR negative) against the ISCT minimal criteria.
  3. Check the cell count and the viability figure, and note the method used — trypan blue and flow cytometry do not always agree.
  4. Check sterility: the method (for example USP <71> or a validated rapid method), the incubation period, and whether the result is final or preliminary at release.
  5. Check mycoplasma and endotoxin, each with a stated limit, not just the word 'negative'.
  6. Check the test dates against the administration date. A sterility test that finishes after you are treated is a risk-management decision the clinic should explain.
  7. Check the signature block: a named person with a role, not an unsigned PDF.

What good looks like, and what should worry you

Verification signals for Read a Certificate of Analysis
What you are checkingAn acceptable answerA red flag
Batch identityA lot number that matches your productA generic example CoA with no lot number
Test columnsTest, method, specification, result, pass/failOnly a results column, or a bare 'passed'
Identity markersFull ISCT marker panel, positive and negative'MSCs' asserted with no marker data
TimingTests dated before release, with any pending test namedNo dates at all
SignatureA named, dated release signatureUnsigned, or signed by the sales contact
AvailabilityYour own batch CoA offered before treatment'You will receive it afterwards' or never

How we grade claims like these: How we evaluate evidence · Editorial standards · Conflict-of-interest disclosure.

Documents to request in writing

Ask by email so the answer is documented. A clinic that cannot send these before payment is telling you something.

  • The Certificate of Analysis for your own batch, before administration
  • The specification sheet the CoA is judged against
  • The method used for each test, including the viability method
  • Any test still pending at the time of release, and how that risk is handled
  • The name and role of the person releasing the batch

Do not write it yourself: copy our ready-made email and WhatsApp request.

Frequently asked questions

You should be able to see one. Practices vary on whether the original is handed over or reviewed with you, but a clinic that refuses to show you the release data for the product going into your body has removed your ability to verify anything.

For short-shelf-life products this can be legitimate — full sterility culture takes up to 14 days. What matters is that the pending test is named, that a rapid screening method was used in the meantime, and that there is a written procedure for notifying you if the final result fails.

No. Hospital lab reports describe you. A CoA describes the product. Ask for both.

Any document can. That is why the issuing laboratory, its licence and its GMP scope matter, and why consistency between the CoA, the specification and the licence is the thing to check rather than the certificate alone.

Sources

  1. Dominici et al. Minimal criteria for defining multipotent mesenchymal stromal cells (ISCT position statement)
  2. USP <71> Sterility Tests
  3. European Pharmacopoeia 2.6.7 — Mycoplasmas
  4. European Commission EudraLex Volume 4 — GMP guidelines

Related verification guides

Use this on us too

Send these questions to us exactly as written. We answer them with documents, and if something does not apply to your case we say so.

Ask for the documentation · Back to the verification hub

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