Potency Assay
A pre-release laboratory test that confirms a cell batch's biological activity — not just cell count.
Lab & Quality
What is Potency Assay?
A potency assay is a functional release test that confirms a batch of MSCs is biologically active, not merely alive. Common assays measure IDO (indoleamine-2,3-dioxygenase) induction under interferon-γ stimulation, T-cell proliferation suppression, or quantified secretion of regenerative cytokines such as VEGF, HGF and TSG-6. Batches that fail potency are rejected even if viability is high — a key reason MSC outcomes vary between clinics.
Related terms in Lab & Quality
GMP (Good Manufacturing Practice)
An internationally recognised standard for the safe, sterile, reproducible production of biological and pharmaceutical products.
Cell Passage
How many times a stem cell population has been expanded in culture. Lower passages (P2–P5) are clinically preferred.
ISCT MSC Criteria
The 2006 International Society for Cell & Gene Therapy definition that all clinical MSCs must meet.
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