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How to verify mycoplasma testing on a cultured cell product

Mycoplasma contamination is invisible: no turbidity, no smell, no change in the culture that you could see. Any expanded cell product must be tested for it specifically.

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

Because mycoplasmas pass through standard sterilising filters and do not show up in routine sterility culture, they need their own assay — a nucleic-acid amplification test validated against Ph. Eur. 2.6.7 or the equivalent culture and indicator-cell methods. Ask whether the test is NAT or culture-based, whether it was run on the final product or only on an earlier passage, and ask to see the result on your batch CoA.

How to verify it, step by step

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

  1. Ask whether the product was culture-expanded at all. Any expanded product must be mycoplasma tested; the question is not optional.
  2. Ask which method: a validated NAT/PCR assay gives a same-day answer, culture-based methods take up to 28 days.
  3. Ask at which stage the sample was taken — final product is what matters, an early passage is not sufficient on its own.
  4. Ask for the limit of detection of the assay and whether it was validated for this product matrix.
  5. Check that the result appears on your batch CoA with a date, not as a general policy statement.
  6. Ask what the procedure is for a positive result, including discard and investigation.

What good looks like, and what should worry you

Verification signals for Verify mycoplasma testing
What you are checkingAn acceptable answerA red flag
Tested at allExplicit mycoplasma line on the CoAAssumed covered by 'sterility'
MethodValidated NAT/PCR, or compendial culture plus indicator cellUnspecified 'screening'
StageFinal product, or final harvestOnly a research-stage master bank
ValidationStated limit of detection for this matrixNo validation data
DocumentationDated, batch-specific negative resultA policy sentence in a brochure
Failure handlingBatch discarded and investigatedNo procedure described

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 mycoplasma result for your batch, with method and date
  • The assay's validation summary or limit of detection
  • The sampling stage the test was run at
  • The written action taken on a positive result

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

Frequently asked questions

No. Mycoplasmas lack a cell wall, grow poorly in standard sterility media and are not reliably detected by the compendial sterility test. That is precisely why a dedicated assay exists.

The direct clinical risk from an infused contaminated product is not well quantified, but contamination indicates a loss of process control and can alter cell behaviour and potency. The correct response is to discard the batch, not to weigh the risk against the schedule.

Products that are not culture-expanded carry a much lower risk, and requirements differ by framework. If the clinic tells you your product is not expanded, that itself is a claim worth confirming against the CoA.

A dated line naming the method, for example 'Mycoplasma (NAT, Ph. Eur. 2.6.7): not detected', tied to your lot number.

Sources

  1. European Pharmacopoeia 2.6.7 — Mycoplasmas
  2. European Commission EudraLex Volume 4 — GMP guidelines
  3. mycoplasma detection nucleic acid amplification cell therapy validation — Assay-validation literature.

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