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Products - STEMAssays    Page   1  |  2  | 
 
  • STEMGlo™: Cell

    Proliferation Assays

  •  STEMClone™:

    Clonal Assays

  • StemGlo™-Potency:

    Cell Potency Assays

  • STEMGlo™-Tox HT:

    Toxicity Assays

  •  STEMGlo™-PRT:

    Residual Toxicity Assays

STEMGlo™

 

A Flexible, Standardized and Validated 96-Well, Bioluminescence Assay Kit to Measure Proliferation, Viability and Functionality of ES and iPS Cells, Primary Explanted Cells, Transformed Cell Lines and Cancer Cells.

 

can now be viewed and ordered at

 

www.preferred-cell-systems.com

STEMClone™

A Standardized Methylcellulose, 96-Well Bioluminescence Clonal Proliferation and Differentiation Assay for ES and iPS Cells, Primary Cells, Transformed Cell Lines and Cancer Cells

 

can now be viewed and ordered at

 

www.preferred-cell-systems.com

STEMGlo™ Potency 

A Standardized and Validated 96-Well, Bioluminescence Potency and Quality Assay Kit to Release Stem Cell Products for Use 

 

GO TO Preferred Cell Systems

 

 

Articles on stem cell potency

Click image for larger view

 

What is Stem Cell Potency?
  • Stem 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.
  • Stem cell proliferation potential or capacity correlates directly with stem cell self-renewal and primitiveness or "stemness". Thus, the greater the proliferation potential, the greater the self-renewal capacity and the more primitive the stem cell population. The more primitive a stem cell population, the greater its potency.
  • Potency must correlate with a response, but not necessarily the clinical outcome.

 

Application / Research Areas
  • Stem cells
  • Cell potency
  • Cellular therapy
  • Regenerative medicine
  • Cell proliferation
  • Cell viability

 

Uses of STEMGlo™-Potency
  • To determine stem cell potency and quality in a single assay for any stem cell product used for a therapeutic application. (See HALO®-Potency and MSCGlo™-Potency for hematopoietic and mesenchymal stem/stromal cell potency assays).
  • To use both stem cell potency and quality to define release criteria and determine if a product can be released for use.
  • To establish in-house reference standards that allow the potency ratio (measure of potency) to be determined.
  • To use an FDA complient potency assay for stem cell therapy products.
  • To promote "Best Practice Criteria Testing". 

 

Benefits of using STEMGlo™-Potency Prior to Using a Stem Cell Product
  • STEMGlo™-Potency is the only commercially available, reference standard-based stem cell potency assay designed for use with ES-, iPS or primary stem cell therapy products.
  • STEMGlo™-Potency reliably estimates the stem cell potency ratio and quality of one or more stem cell populations simultaneously against a reference standard to predict whether the product will grow prior to use.
  • STEMGlo™-Potency 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.
  • Assay can be completed in 4-7 days depending on the cells being tested.
  • STEMGlo™-Potency can help any laboratory achieve "Best Practices" and measurement assurance promoted by the National Institute of Standards and Technology (NIST) .

 Principle, Sensitivity and Parameters of ATP Bioluminescence Assays

Download information on the principle of ATP bioluminescence assays, sensitivity and other parameters

 The Stem Cell Reference Standard
  • To measure potency, a reference standard (RS) of the same material and purity as the sample is required so that the potency ratio can be determined. The inclusion of a RS to measure potency is an FDA requirement. Universal or global reference standards for stem cell products are not available. As a result, it is necessary for individual centers to establish their own in-house RS. To accomplish this, a standardized and validated assay platform is required.
  • STEMGlo™-Potency can be used to establish reference standards. A batch of stem cells is prepared and processed to the required purity, aliquoted and cryopreserved and it's potency determined using the STEMGlo™-Potency assay. Other secondary and tertiary RSs are also prepared. The RS is then used to compare to the sample of unknown potency.

 Availability of STEMGlo™-Potency Assays

 

STEMGlo™-Potency Assays Kits Available to Determine

Stem Cell Potency, Quality and Release

Assay Type Cell Type Populations Measured (*) Catalog Number Number of Plates/Kit

Number of Samples/Kit

Click to see price

STEMGlo™-Potency

Any ES, iPS or primary stem cell population Preferably a minimum of 2

KSG-PQR-1

1

1 + RS

Price
STEMGlo™-Potency Any ES, iPS or primary stem cell population Preferably a minimum of 2

KSG-PQR-2

2

2 + 2 RS(1) or

3 + 1 RS(1)

Price
STEMGlo™-Potency Any ES, iPS or primary stem cell population Preferably a minimum of 2

KSG-PQR-4

4

6 + 1 RS(1) or 

4 + 4 RS(1)

Price

(1): One RS must always be performed when an unknown sample is measured. If more than 1 sample is to be measured, a single RS of the same cell type and purity can be used to compare with all samples performed on the same day.

 Tissues and Cell Purity Required for Assay
  • Embryonic stem (ES) cells
  • Induced pluripotent stem (iPS) cells
  • Primary stem cells obtained from any tissue or organ. PLEASE NOTE that separte potency assays are available for hematopoietic and mesenchymal stem/stromal cells.

Stem 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. 

 Example of How Potency is Measured

See information on HALO®-Potency to see how potency is measured in vitro.

 Use and Major Equipment Required

For Research Use Only. Not for clinical diagnostic use

Major Equipment Required

A plate luminometer or multiparameter plate reader capable of measuring "glow" luminescence is needed for this assay.

 Assay Kit Contents
  • 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
  • Assay manual

 STEMGlo™-Potency Quick Guide and Assay Manual

Download the STEMGlo™-Potency Quick Guide

The STEMGlo™-Potency Assay Manual can be accessed from the Resources section here

STEMGlo™-Tox HT

ATP Bioluminescence™ In Vitro Cytotoxicity Assays for Primary Cells, Stem Cells and other Cell Lines

 

can now be viewed and ordered at

 

www.preferred-cell-systems.com

STEMGlo™ PRT

ATP Bioluminomics™ Predictive Residual Toxicity Assays for Stem Cells

 

can now be viewed and ordered at

 

www.preferred-cell-systems.com