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- W2073984146 abstract "Potency is defined as a quantitative measure of biological activity based on a product's intended use. There are several reasons why potency is important. It ensures manufacturing consistency and stability. It allows prediction and/or assurance for the product's performance. It allows evaluation and correlation with the clinical dose. Most important, it avoids product failure and/or toxicity due to improper potency. It follows that potency is a predictor; it cannot be used after the fact as a measure of outcome. For umbilical cord blood (UCB) transplantation, none of the parameters presently used to assess a UCB unit (total nucleated cell (TNC) count, viability, CD34 or colony count from the CFU assay) can be considered potency assays because they do not comply with the definition of potency and stem cell potency, in particular. The intended use is engraftment of the hematopoietic system. For engraftment to occur, the transplanted stem cells have to demonstrate their capability to proliferate. This capability is a measure of stem cell “quality”. The hematopoietic stem cell compartment is not comprised of a single stem cell population, but a continuum of stem cells with different degrees of self-renewal capacity and proliferation potential (PP). These in turn, will define long- and short-term engraftment potential. The potency assay must therefore measure PP in order for it to predict engraftment potential. A UCB stem cell assay has been developed that measures the PP of two stem cell populations simultaneously, one primitive (HPP-SP), the other mature (CFC-GEMM). A cell dose response for both populations is then compared to a UCB reference standard preparation (a requirement to measure potency). Proliferation status (stem cell quality) and potential are measured by their correlation with the intracellular ATP concentration using a luciferin/luciferase luminescence reporter to produce light that is measured in a plate luminometer. The resulting linear regression slope of the dose response is a direct measure of stem cell PP and therefore potency. Stem cell quality and potency together then provide the acceptance criteria for the UCB unit to be released for transplantation. In a single assay, that can be easily validated, all three parameters, potency, quality and release can be determined simultaneously. Without previous knowledge of hematopoietic stem cell biology, the requirements for a potency assay could not have been met." @default.
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- W2073984146 date "2010-02-01" @default.
- W2073984146 modified "2023-09-26" @default.
- W2073984146 title "The Biology And Measurement Of Hematopoietic Stem Cell Potency" @default.
- W2073984146 doi "https://doi.org/10.1016/j.bbmt.2009.12.305" @default.
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