Loading...
Loading...
Quality assurance and testing documentation for Quantum Cell Factor products.
Product Name
Cell Factor
Manufacturer
Cellestiq Lab, LLC
Batch/Lot Number
TGRR25G053-100125
Manufacture Date
2025-10-01
Expiration Date
2027-09-30
Overall Status
All Tests Passed
-80°C
20-25°C
| Test Parameter | Specification | Result | Method | Status |
|---|---|---|---|---|
| Appearance | Clear to opalescent solution | Clear | Visual Inspection | PASS |
| pH | 6.5 - 7.5 | 7.4 | pH Meter | PASS |
| Osmolality | 270 - 330 mOsm/kg | 290 mOsm/kg | Osmometer | PASS |
| Sterility | No growth | No growth | USP <71> | PASS |
| Endotoxin | < 0.5 EU/mL | < 0.5 EU/mL | LAL Assay | PASS |
| Mycoplasma | Not detected | Not detected | PCR | PASS |
| CD73 Marker | Positive | Positive | Flow Cytometry | PASS |
| CD90 Marker | Positive | Positive | Flow Cytometry | PASS |
| CD105 Marker | Positive | Positive | Flow Cytometry | PASS |
| HLA-DR, CD14, CD19, CD34, CD45 | < 2% | < 2% | Flow Cytometry | PASS |
| Protein Concentration | 0.5 - 2.0 mg/mL | 4.0 mg/mL | DCA Assay | PASS |
| HIV 1 | Non-Reactive | Non-Reactive | Eurofins | PASS |
Access the complete Certificate of Analysis with all test results, signatures, and compliance documentation.
Reviewed by
Carlo Ledesma
Title
Quality Control Manager, Cellestiq Lab, LLC
Date
2025-11-07
DocuSign Envelope ID: 70AD6E2A-D58E-482E-9985-C86D6A46DE11
For use under HCT/P guidelines (21 CFR 1271) and Section 361 of the Public Health Service Act.
For questions about this Certificate of Analysis or product specifications, please contact RegenTherapy.
Contact Support