NOW ASYMMETREX® PROVIDES A POTENCY TEST FOR TISSUE STEM CELLS

FDA 21CFR 600.3 definitions: “The word potency is interpreted to mean the specific ability or capacity of the product … to effect a given result.”

In many cases of tissue stem cell treatments and gene therapy treatments that target tissue stem cells (like hematopoietic stem cells), the desired result is the life-long replenishment of mature functional cells of the treated organs and tissues.

Potency assay attributes are:

• Indicate biological activities specific and relevant to the product.
• Measure activity of all ingredients considered necessary for activity.
• Indicate product stability.

The TORTOISE Test KSC counting analysis has each of these potency assay attributes for evaluating therapeutic tissue stem cell products:

• Indicating the specific dosage of therapeutic tissue stem cells.
• Measuring the treating stem cells’ specific rate of replenishment of mature functional tissue cells.
• Indicating the specific death rate and loss rate of tissue stem cells during culture expansion or storage.

Download an Example TORTOISE Test Potency Report today!