Standards · Quality Control
Quality control.
Per-lot quality control is what turns a research-supply preparation into a defensible input to a research protocol. Every lot we ship carries the QC envelope below on its Certificate of Analysis.
Per-lot QC panel — cell preparations
- Viability. Trypan blue or 7-AAD dye exclusion; minimum threshold per product specification.
- Identity. Surface marker panel by flow cytometry. ISCT-aligned for MSC preparations (CD73 / CD90 / CD105 +; CD14 / CD34 / CD45 / HLA-DR −).
- Sterility. USP <71> or equivalent in-process check.
- Mycoplasma. PCR negative on the source lot or source cell line.
- Endotoxin. LAL assay; lot-specific target threshold per product specification.
- Donor identifier. Linked to donor eligibility documentation.
- Passage at vialing. For expanded preparations.
Per-lot QC panel — extracellular vesicles (MISEV-aligned)
- Particle count. Nanoparticle Tracking Analysis (NanoSight or equivalent).
- Size distribution. Mean, mode, and D90.
- Tetraspanin panel. CD9 / CD63 / CD81 — flow or western.
- Source-cell identity. Donor identifier and source-cell passage on file.
- Endotoxin. LAL, < 0.5 EU/mL target.
- Sterility. USP <71> or in-process equivalent.
- Mycoplasma. PCR negative on the source cell line.
- Storage and handling history. Cryopreservation method, freeze-thaw cycles, shipping conditions.
Add-on characterization (available on request)
- Mitochondrial membrane potential (TMRM, JC-1, MitoTracker)
- Mitochondrial mass (MitoTracker Green or NAO)
- ATP content per cell
- Tri-lineage differentiation potential demonstration
- Particle-to-protein ratio for EV preparations
- Activated-state markers for platelet-derived EV preparations
- Extended endotoxin or pyrogen profile
Statistical sampling and lot definition
A lot is defined as material processed from a single donor source (or a defined donor pool) on a single processing date under a single processing protocol. Per-lot QC is performed on representative aliquots from the released lot. Statistical sampling standards follow the manufacturer's qualified sampling plan, reviewed during supplier qualification.
Out-of-specification handling
Lots failing any QC parameter are placed on hold and not released to customers. Out-of-specification investigations are conducted by the manufacturing partner with ExoBioCorp's review. Where the OOS investigation identifies a root cause that may affect other lots, ExoBioCorp will notify customers consistent with our quality system commitments.