GMP laboratory: what is certified, and how to verify it
Every "GMP-certified" claim on this site points here. Good Manufacturing Practice is a manufacturing standard for the laboratory and the process — not a licence for a hospital, and not proof that a therapy works. This page states exactly what is certified, by whom, and how you can ask to see it.
Laboratory record
| Field | Detail |
|---|---|
| Partner laboratory | ONKIM Stem Cell Technologies, Istanbul |
| Function | Isolation, expansion, characterisation, cryopreservation and release of MSC and exosome products |
| Manufacturing standard | GMP (Good Manufacturing Practice) clean-room production |
| Regulator | Republic of Türkiye Ministry of Health — advanced cellular therapy framework |
| Licences held | Production centre licence · exosome production centre licence · umbilical cord banking licence · cord blood study approval |
| Quality management | ISO 9001 quality management system |
| Scientific direction | Prof. Dr. Erdal Karaöz |
| Donor ethics | Full-term consented C-section umbilical cord donations, Declaration of Helsinki compliant |
What GMP certification actually covers
What it does not cover: clinical efficacy for any given condition, the hospital environment (that is JCI), or approval of a therapy for a specific disease. We keep those claims separate deliberately.
- Clean-room classification, environmental monitoring and controlled airflow in the areas where cells are handled.
- Documented, version-controlled standard operating procedures for every manufacturing step.
- Full chain of custody from donor consent to the vial administered to a patient.
- Qualified-person batch release: a product cannot leave the laboratory until defined criteria are met and signed off.
- Deviation, complaint and recall handling with an auditable record trail.
Release criteria checked before any batch reaches a patient
| Test | Purpose |
|---|---|
| Cell viability | Confirms the proportion of living cells meets the defined minimum before release |
| Sterility (bacteria and fungi) | Excludes microbial contamination of the final product |
| Mycoplasma | Excludes a contaminant invisible to standard sterility testing |
| Endotoxin | Limits pyrogenic response risk on infusion |
| Immunophenotype (flow cytometry) | Confirms the cells carry the expected MSC surface marker profile |
| Cell count and dose | Confirms the prescribed dose for the patient's protocol |
How to verify
- Ask for the GMP certificate and the Ministry of Health production licence references for the batch prepared for you — the coordination team provides them on request during consultation.
- Ask for the batch release record after treatment; it names the tests above and their results for your specific product.
- Cross-check the licensing framework itself with the Republic of Türkiye Ministry of Health rather than relying on any clinic's summary.
- See the wider certificates overview and credentials and quality pages for the full regulatory stack.
Frequently asked questions
Does GMP mean the treatment is approved for my condition?
No. GMP governs how the cell product is manufactured. Whether a therapy is appropriate for your condition is a separate clinical question, answered by a named physician after reviewing your records — see our evidence summaries for where the science currently stands by indication.
Can I see the GMP certificate before travelling?
Yes. Request it via the contact form and it is shared as part of the pre-treatment documentation pack, together with the hospital and licence references.
Who manufactures the cells — the clinic or a third party?
A dedicated partner laboratory, ONKIM Stem Cell Technologies, manufactures under GMP. StemCell Longevita coordinates; it does not manufacture cells itself.
Ask for the documentation
Our coordination team can share laboratory certificates, licence references and hospital accreditation details during your consultation, alongside a medical review of your own records.
Request a free medical review