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!