David Lansky, PhD, President, Precision Bioassay, Inc.
Bioassays are challenging to optimize because they are complex processes with inputs applied to different-sized units. For example, cell-based assays have factors assigned to wells, rows, columns, plates, incubators, and cell preparations. Combining practical constraints from the laboratory with constraints from design of experiments is much easier if we construct the assay with layered or modular design components. Experimental designs for development, validation, and production share common modules, but in different numbers at various levels of the design. By measuring the performance of the method, the properties of reported values for each of several different intended uses can be supported from a single efficient validation (or pre-validation) experiment. Additionally, modular design and appropriate analyses support efficient development and robustness of experiments, as well as allowing easy adjustments to the assay format as the assay system matures.