Evaluating Cell Health for Cell Therapy Products
Material Measurement Laboratory, Biosystems and Biomaterials Division
NIST only participates in the February and August reviews.
Cell viability is a crucial measurement for advanced therapies such as cell and gene therapies and regenerative medicine, where live cells are the therapeutic agent. Cell viability measurements are conducted throughout the manufacturing process of cell-based products and also serve as release criteria. Unfortunately, common measures of cell viability including dye-exclusion, often do not correlate to product manufacturability or the ability to meet dose. Novel approaches are needed to evaluate cell health, taking into account the complex properties of living cells and mechanisms of cell death. In this project, we will evaluate the health of cells using a wide range of cell viability assays and advanced imaging with the goal of establishing a matrix of cell viability assays that predict cell health as it relates to manufacturability and basic cell functions. Advanced automation systems will also be employed to generate control samples with varying degrees of cell health to serve as training data for prediction modeling.