MSCGlo™ SC-IPS

MSCGlo™ RS

The Only Standardize and Validated Mesenchymal Stem Cell (MSC) Assay That Allows
Measurement of Identity, Purity and Strength (Potency) of regenerative Medicine Products for Use

 

Buy MSCGlo™ RS Assay Kits

 

Buy MSCGlo™ SC-IPS Assay Kits


The Only Standardize and Validated Mesenchymal Stem Cell (MSC) Assay That Allows Measurement of Potency, Quality and the Release for Regenerative Medicine Products for Use
 

  • Cell strength or potency is the quantitative measurement of cell proliferation potential. This, in turn, is a measure of cell primitiveness and cell engraftment potential.
  • Cell strength predicts a specific response associated with the intended effect. This is usually the capacity of cells to home, seed and begin proliferation at a particular location in the body. Cell potency does not predict whether the cells will actually differentiate and produce functional mature cells.
  • To determine identity, purity and strength (potency) of native or expanded MSCs from any source and multiple species.
  • An ATP bioluminescence, reference standard-based potency assay for MSC manufactured and produced for clinical use.
  • Determines population doubling time (PDL), viability, proliferation ability (quality) and proliferation potential in addition to potency in a single assay.
  • Includes additional standards and controls which, together with the reference standard, allows the assay to be validated.
  • Customize the assay with either CRUXRUFA™ Human Platelet Lysate GM or GMP+Q grade, serum-free/xeno-free or humanized MSCGro™ Medium. 
  • Compliant with FDA regulations for potency assays.
  • Uses the "Slope-Ratio Concentration-Response Model" to determine the measure of potency, the potency ratio, standardized in the U.S. Pharmocopeia.

Principle of ATP Bioluminescence Cell Proliferation Assays

All ATP bioluminescence assays kits from Preferred Cell Systems™ include an ATP standard(s) and controls.  Performing the ATP standard curve and controls is highly recommended. The controls are used to calibrate the instrument and the ATP standard is used to standardize the assay. The values obtained provide the measurement assurance parameters that allow you, the user, to ensure that the results obtained can be trusted.

An example of an ATP standard curve and control results are shown in the diagram below and actual values for the kit being used are given in the Technical Manual. If the values obtained are within the ranges given in the Technical Manual, the user can process the samples knowing that the results will be trustworthy.

Calibration and standardization of an ATP bioluminescence assay from Preferred Cell Systems™ - Measurement Assurance
 
  • CRUXRUFA™ Human Platelet Lysate
  • MSCGro™ Low serum, complete
  • MSCGro™ Serum-free, xeno-free, complete
  • MSCGro™ Humanized, complete

Difference between MSCGlo™ SC-IPS and MSCGlo™ RS

To measure potency, a reference standard of the same material as the sample is required so that the potency ratio can be determined. The inclusion of a reference standard to measure potency is an FDA requirement. Universal or global reference standards for cell therapy products are not available. As a result, it is necessary for individual centers to establish their own reference standards.

MSCGlo™ RS is used to establish your first in-house reference standard. The assay includes a vial of cord blood, peripheral blood or bone marrow cryopreserved cells that are used to compare to your own preparation. MSCGlo™ RS is only required once to set up your first reference standard cell preparation. All further reference standards establish in-house will be compared to the previous reference standard. 

To measure strength or potency of your samples prior to use, MSCGlo™ SC-IPS is used. MSCGlo™ SC-IPS does not include reference standard material. You will use an in-house reference standard to measure the potency ratio of the sample.

 

MSCGlo™ RS Assays Kits Available to Establish an

In-House Reference Standard (RS) for Mesenchymal Stem Cells

Assay Type Catalog Number MSC Source Growth Medium Formulation Number of Plates/Kit
MSCGlo™ RS KLMC-CRRS-1CB Cord blood CRUXRUFA™ Human Platelet Lysate 1
MSCGlo™ RS KLMC-LSRS-1CB Cord blood Low serum 1
MSCGlo™ RS KLMC-SFRS-1CB Cord Blood Serum free 1
MSCGlo™ RS KLMC-HMRS-1CB Cord blood Humanized 1
MSCGlo™ RS KLMC-CRRS-1BM Bone marrow CRUXRUFA™ Human Platelet Lysate 1
MSCGlo™ RS KLMC-LSRS-1BM Bone marrow Low serum 1
MSCGlo™ RS KLMC-SFRS-1BM Bone marrow Serum free 1
MSCGlo™ RS KLMC-HMRS-1BM Bone Marrow Humanized 1
 

MSCGlo™ SC-IPS Assays Kits Available to Determine

Mesenchymal Stem Cell Potency, Quality and Release

Assay Type Catalog Number MSC Source Growth Medium Formulation Number of Plates/Kit

MSCGlo™ SC-IPS

KLMC-CRP-1 Any(1) CRUXRUFA™ Human Platelet Lysate 1

MSCGlo™ SC-IPS

KLMC-LSP-1 Any(1) Low serum 1
MSCGlo™ SC-IPS KLMC-SFP-1 Any(1) Serum free 1
MSCGlo™ SC-IPS KLMC-HMP-1 Any(1) Humanized 1


(1): If the MSC source is not cord blood or bone marrow, use MSCGlo™ RS to establish a reference standard (RS) for that tissue source. A RS must always accompany a sample when strength or potency is measure, since the potency ratio can only be determined by comparison of the sample with a RS.

 

For Research Use Only. Not for clinical diagnostic use.

Luminescence or multimode plate reader with "glow" luminescence measuring capability.

MSCGlo™ RS Kit Contents:

  • Vial of cryopreserved reference standard MSCs derived from either bone marrow or umbilical cord blood. For MSCs derived from other tissues, an in-house reference standard can be established using MSCGlo™ Potency
  • CRIXRUFA™ Human Platelet Lysate OR
  • MSCGro™ Medium of choice
  • ATP standards
  • ATP controls
  • ATP Enumeration Reagent
  • Sterile, 96-well plate(s)
  • Non-sterile, 96-well plate(s)
  • Sterile, adhesive foil covers

 

MSCGlo™ SC-IPS Kit Contents:

  • CRUXRUFA™ Human Platelet Lysate OR
  • MSCGro™ Medium of choice
  • ATP standard
  • ATP controls
  • ATP Enumeration Reagent
  • Sterile, 96-well plates
  • Non-sterile, 96-well plates
  • Sterile, adhesive foil covers

MSCGlo™ SC-IPS Assay Manual

The Only Standardize and Validated Mesenchymal Stem Cell (MSC) Assay That Allows Measurement of Potency, Quality and the Release for Regenerative Medicine Products for Use