Title: Analytical measurements supporting cellular therapies
Explore the applications of cell counting through context of use
The decisions concerning how, when, and why laboratory measurements are made are dictated by their context of use (COU) (i.e. the intended use of the data and its associated regulatory requirements). Moreover, assay performance requirements are also mandated by the COU. This is true for complex assays such high-dimensional, spectral flow cytometry, as well as simple methods such as counting cells. In the development of cell therapies both types of assays are required. In this article, the influence of the COU on the cell counting measurements used for cell therapy manufacturing, development and clinical evaluation are discussed.