Quality & COA
Quality, COAs and cold chain
What is on the certificate, how a lot is released, and the one thing about our facility we disclose rather than market.
What release actually is
A lot does not leave because somebody looked at it and was satisfied. It leaves because a written panel of tests came back inside limits that were set before the lot existed, and the certificate names every test, every limit and every result — including the ones that only just passed.
Sterility is the slow one. It is a fourteen-day incubation, and no amount of commercial pressure shortens it.
MSC lot release
- Viability (≥ 80% post-thaw)
- Cell count
- ISCT surface-marker panel by flow cytometry
- Tri-lineage differentiation (lot qualification)
- Sterility (USP <71>)
- Endotoxin (USP <85>)
- Mycoplasma
- Karyotype / genomic stability
Exosome lot release (extended)
- Particle count and size distribution by NTA
- Tetraspanin markers (CD9 / CD63 / CD81)
- Total protein
- Sterility (USP <71>)
- Endotoxin (USP <85>)
- Mycoplasma
- Particle:protein purity ratio
- Absence markers (calnexin)
- Functional potency surrogate
- Residual-reagent assay
Disclosure
Human and equine tissue in one facility
Both grades are manufactured in the same cGMP facility. That is an efficiency, and it is also a cross-contamination risk that has to be controlled and disclosed rather than sold as a feature.
- Campaign-based changeover with documented cleaning validation between species.
- Physical and temporal segregation of human and equine tissue processing.
- Donor eligibility, serology and nucleic-acid testing records retained per lot.
- Species identity confirmed on the finished product, not assumed from the batch record.
We do not claim our manufacturing standard makes the product work better. Manufacturing quality controls what is in the vial and how consistent it is. It does not create clinical evidence, and no certificate can substitute for a trial.
Cold chain: each case carries an irreversible time-temperature indicator. The indicator is the sensor; the QR code is how you read it and report an exception.