chapter  4
16 Pages

Experimental Design for Bioassay Development and Validation

ByDavid M. Lansky

Biological assays using cultured cells are a crucial part of the quality-control process for pharmaceutical protein products. These assays can have large variation and can require substantial effort to develop, perform, analyze, and validate. The assignment of reference samples and dilutions to locations on 96-well cell-culture plates is only one aspect of experimental design for these assays. This chapter will suggest how classical experimental design methods (factorial screening designs, response-surface designs, Latin Square, split-plot, strip-plot, and nested designs) can be effectively used in the development, routine performance, and validation of cell-culture bioassays.