Regenex Quality Standards & Certificate of Analysis
Quality in cell therapy is not a marketing differentiator — it is a patient safety requirement. Every product that leaves our laboratory has been manufactured under cGMP conditions and tested against defined release specifications. If a batch fails any test, it is rejected. No exceptions.
What We Test — Every Batch, Every Product
| Test | What It Confirms | Why It Matters |
|---|---|---|
| Sterility | No bacterial or fungal contamination | Contaminated product can cause serious infection |
| Viability | ≥90% live, functional cells | Dead cells have no therapeutic value |
| Endotoxin | Below <0.5 EU/mL | Bacterial toxins cause severe inflammatory reactions |
| Mycoplasma | Negative (PCR testing) | Common contaminant that compromises integrity |
| Cell phenotype | Correct surface markers | Confirms cells are what they should be |
| Potency | Functional activity assay | Proves the product works, not just that cells are alive |
| Particle characterisation | 30–150nm, CD9/CD63/CD81 (exosomes) | Confirms genuine exosomes, not cellular debris |
The Certificate of Analysis
Every Regenex product is accompanied by a batch-specific Certificate of Analysis documenting all test results for that specific batch — including batch number, manufacturing date, all quality test results, pass/fail status and the releasing quality officer's sign-off. The CoA is specific to the exact batch used in your treatment or delivered to your clinic.
A redacted sample CoA will be available for download soon. Contact us for a preview.
What Happens When a Batch Fails
If any batch fails any quality test, it is quarantined, investigated and rejected. Failed batches are never released for clinical use. Our quality management system requires root cause investigation, corrective action and documented evidence that the issue is resolved before manufacturing resumes.
This is standard practice in pharmaceutical manufacturing. It should be standard in cell therapy manufacturing too. At Regenex, it is.