MSCGlo™ RS and MSCGlo™ SC-IPS

A Standardized and Validated In Vitro
Bioluminescence Assay Platform to Measure
the Potency Mesenchymal Stromal Cells (MSC)
Used in Regenerative Medicine

 

 

MSCGlo™ RS

A Standardized and Validated In Vitro Bioluminescence Assay to Establish Potency Reference Standards for Mesenchymal Cells

Cell Population Tissue Formulation Catalog Number Quantity
Mesenchymal Stem/Stromal Cells Bone marrow-derived MSCs Low serum KLMC-LSRS-1BM 1 Kit
Mesenchymal Stem/Stromal Cells Bone marrow-derived MSCs Serum-free, Humanized KLMC-SFRS-1BM 1 Kit
Mesenchymal Stem/Stromal Cells Cord blood-derived MSCs Low serum KLMC-LSRS-1CB 1 Kit
Mesenchymal Stem/Stromal Cells Cord blood-derived MSCs Serum-free, Humanized KLMC-SFRS-1CB 1 Kit

MSCGlo™ SC-IPS

A Standardized and Validated In Vitro Bioluminescence Assay to Measure Mesenchymal Cell (MSC) Potency

Cell Population Tissue Formulation Catalog Number Quantity
Mesenchymal Stem/Stromal Cells Human Low serum KLMC-LSP-1 1 Kit
Mesenchymal Stem/Stromal Cells Human Serum-free, Humanized KLMC-SFP-1 1 Kit

 

MSCGlo™ RS and MSCGlo™ SC-IPS: Standardized and validated assays to establish potency reference standards and measure the potency of mesenchymal cells
 

 

 

  • 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 Mesenchymal Stromal Cells (MSCs) from any source and multiple species.
  • An ATP bioluminescence, reference standard-based potency assay for MSCs manufactured and produced for clinical use.
  • Determines population doubling time (PDL), viability, proliferation ability (quality) and proliferation potential (potency) in a single assay.
  • MSCGlo™ SC-IPS has been validated according to FDA Bioanalytical Method Validation Guidelines. However, additional validation can be performed since assay kits include standards and controls which, together with the reference standard, allows the assay to be validated in-house. Please see the Instruction Manual for validation parameters.
  • Customize the assay with 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 luminescence plate reader and the ATP standard is used to standardize the assay. The values obtained from the standard curve and controls (see diagram below) are then compared to the measurement assurance parameters that are provided in the instruction manual. If the values obtained are within the ranges provided by the measurement assurance parameters, you, the user, have successfully performed the proficiency testing to ensure that you have not only performed the assay correctly, but that the results you obtain can be trusted.

No additional proficiency testing is required if the calibration and standardization procedure is performed. The values you obtain from each calibration and standardization can be logged and used for certification that the assay has been performed correctly and that the results are trustworthy.

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

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
  • 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:

  • 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 to Determine the Potency of Mesenchymal Stromal Cell (MSC)  Regenerative Medicine Product

 

Download the MSCGlo™ RS / MSCGlo™ SC-IPS Technical Manual
Download the ATP Optimization Kit Protocol for First-Time Users
Download the Luminescence Plate Reader Setup and Conversion of RLU to ATP Values Protocol

Download SDS for ATP Enumeration Reagent
Download SDS for ATP Standards and Controls Download Certificate of Analysis (CoAs) for ATP Enumeration Reagent (ATP-ER)
Download Certificate of Analysis for ATP Stanadrds
Download Certificate of Analysis for ATP Controls
Download Certificate of Analysis of ATP Reconstitution Reagent
Download Certificate of Analysis for Sterile 96-Well Plates
Download Certificate of Analysis for Non-Sterile, 96-Well Plates
Download Certificate of Analysis for Sealing Films
Download Certificate of Analysis for IMDM