Design of Experiments (DOE) and Quality by design (QBD) in Bioassay Optimization

This webinar introduces design of experiments (DOE) in the context of bioassay optimization. DOE can be used to screen through a large number of potentially influential factors and highlight a handful of the most important ones. DOE can also be used for optimization and identifying a suitable set-point for running the system over time. There are several design families that can be used for DOE in bioassay analysis and an overview of some of these is given, including some perspectives on their amenability for automation. Once an optimization design has been performed the results can be used for estimating a design space, i.e. a region in which small changes in the important factors do not change the responses appreciably and there is therefore a low risk of failing to comply with specifications. The relationship between a design space and control of the underlying process is discussed. Two pharmaceutical bioassay optimization examples are used for illustration and discussion.