In Vitro Assay for ES, iPS and other
Stem Cell Potency
using Bioluminescence STEMGlo™ SC-IPS
What is Cell Strength or Potency?
- Cell potency is the quantitative and validated measurement of proliferation potential or capacity (biological activity) of the "active" stem cell components to produce the intended effect or response.
- Cell proliferation potential or capacity correlates directly with the primitiveness of the cells in question. For stem cells, the greater their proliferation potential, the greater their self-renewal capacity and the more primitive the stem cell population. The more primitive a cell population, the greater its potency.
- Determines cell potency and quality in a single assay for any ES or iPS stem cells that might be used in a clinical setting.
- STEMGlo™ SC-IPS can determine the identity, purity and strength or potency of a cell population compared to either a reference standard or similar cell source.
- Allows an in-house reference standard to be established to determine the potency ratio.
- Promote "Best Practice Criteria Testing."
- Allows determination of cell identity, purity and strength of a cell population or source if compared to a standard source.
- Allows determination of the cell potency ratio and cell quality simultaneously.
- Uses the standardized 'Slope-Ratio Concentration-Response Model" for measuring potency as described in the U.S. Pharmacopeia.
- Requires as few as 90,000 cells to perform the assay.
- Instrument-based, incorporating an external standard and controls for assay calibration, standardization and validation according to FDA regulations.
- Allows for intra- and inter-laboratory comparisons.
- Most assays require about 3-4 days, but this will depend on the cells being tested.
- Can help any laboratory achieve "Best Practices" and measurement assurance promoted by the National Institute of Standards and Technology (NIST) .
- To measure cell strength or potency, a reference standard (RS) or a cell source of the same material and purity as the sample is required so that the potency ratio can be determined. The cell sample is directly compared to the standard to determine if the cell sample has the same idendity, purity and strength.
- STEMGlo™ IPS can be used to establish a reference standard for a specific cell type. A batch of cells is prepared, processed, aliquoted and cryopreserved and it's strength determined. Other secondary and tertiary RSs are also prepared. The RS is then used to compare to the sample of unknown strength.
- Embryonic stem (ES) cells
- Induced pluripotent stem (iPS) cells
Cell Purity Requirements for Detection
For best results, it is recommended that as few cell impurities as possible are present, since these will mask and dilute the stem cells producing underestimates for the actual stem cell potency and quality.
For Research Use Only. Not for clinical diagnostic use.
Luminescence or multimode plate reader capable of measuring "glow" luminescence is needed for this assay.
- Base medium for diluting ATP standard
- ATP standards
- ATP controls
- ATP Enumeration Reagent
- Sterile, 96-well plate(s)
- Non-sterile, 96-well plate(s)
- Sterile, adhesive foil covers
STEMGlo™ SC-IPS Quick Guide
STEMGlo™ SC-IPS Assay Manual