Quality Assurance
Every Vial. Verified.
Independent lab testing, lot-level traceability, and documented release criteria on every product we ship - before it ever reaches your clinic.
Why Documentation Matters in Regenerative Biologics
In a market where many suppliers advertise particle counts without verification, potency claims without testing, and compliance language without documentation - Stem Nova Network takes a different position. Every product we supply comes with real lot-level test data, not marketing language.
Important: Manufacturing credentials ≠ product approval. The testing documentation, AATB accreditation, and cGTP-compliant manufacturing described on this page are manufacturing quality and facility credentials. They do not constitute FDA approval of any Stem Nova Network product for any therapeutic indication.
Every batch is assigned a unique lot number with full test documentation. When you order, you can trace exactly which lot your product came from and what its test results were.
Testing is performed both in-house and through a qualified independent third-party laboratory. Both results must meet release criteria before a lot ships.
Exosome particle counts are verified via NTA (Nanoparticle Tracking Analysis) using ZetaView instrumentation - not estimated, not extrapolated.
Products do not ship unless all release criteria are met. Failed lots are quarantined and never distributed. This is a hard gate in our manufacturing process.
Exosome Release Testing Results
Sample Certificate of Analysis data from our 60 Billion Exosome Matrix. Each lot shipped carries equivalent documentation with lot-specific results.
| Assay | Method | Specification | Result |
|---|---|---|---|
| Sterility | Direct Inoculation | No Growth | No Growth |
| Mycoplasma | PCR Detection | Negative | Negative |
| Endotoxin | LAL Kinetic Chromogenic | < 0.005 EU/mL | < 0.005 EU/mL |
| Particle Concentration | ZetaView NTA Scatter | 6.0 × 10¹⁰ P/mL | 6.0 × 10¹⁰ P/mL |
| Mean Particle Size | ZetaView NTA Size | Exosome range | 134.0 nm |
| Total Protein | Bradford Assay | Per spec | 4,824.6 μg/mL |
| EV Origin | Source Documentation | hUCT-MSC | Human UCT-MSC |
Stem Cell Release Testing Results
Full release panel for our 25 Million hUCT-MSC product. All assays must pass before lot release.
| Assay | Method | Specification | Result |
|---|---|---|---|
| Sterility | Direct inoculation per 21 CFR 610.12 | Negative | Negative |
| Endotoxin | LAL per USP <85> | ≤ 10 EU/mL | 0.935 EU/mL |
| Mycoplasma | USP <63> / EP <2.6.7> | Negative | Negative |
| Cell Count | Automated Cell Count | ≥ 2.0 × 10⁷ cells/vial | 2.4 × 10⁷ |
| Cell Viability | Automated Viability | ≥ 70% | 97% |
| CD90 Expression | Flow Cytometry | ≥ 80% | 100% |
| CD166 Expression | Flow Cytometry | ≥ 80% | 100% |
| CD34 (negative) | Flow Cytometry | ≤ 20% | 1.1% |
| CD45 (negative) | Flow Cytometry | ≤ 20% | 1.5% |
Pathogen Testing - All Negative
Each lot of hUCT-MSC product is screened for the following pathogens prior to release.
HIV
Negative
HBV
Negative
HCV
Negative
HTLV
Negative
CMV
Negative
EBV
Negative
HHV
Negative
HPV
Negative
B19
Negative
Mycoplasma
Negative
Retroviral
Negative
Adventitious
Negative
Manufacturing Documentation for Your Practice
Stem Nova Network operates from an AATB-accredited, FDA-registered tissue establishment under cGTP standards (21 CFR Part 1271). These are facility and manufacturing credentials — they do NOT constitute FDA approval of any product for any therapeutic indication.
Manufacturing
cGTP-Compliant Production
Documented SOPs, environmental monitoring, and batch records.
Sterility
21 CFR 610.12
Direct inoculation - the regulatory standard for biological products.
Endotoxin
USP <85> LAL Method
LAL per United States Pharmacopeia standard USP <85>.
Mycoplasma
USP <63> / EP <2.6.7>
Dual-standard compliance - USP and European Pharmacopoeia.
Tissue Sourcing
FDA 21 CFR Part 1271
Full donor eligibility requirements for human cells and tissue products.
Particle Analysis
NTA - ZetaView
Verified particle count, mean size, and size distribution per lot.
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