Concepts and Tools for Building Models for Design Space

The ICH Q8 definition of design space is “The multidimensional combination and interaction of input variables (e.g. material attributes) and process parameters that have been demonstrated to provide assurance of quality”.  This means that to create a design space we should have a type of model that will allow us to quantify the probability of meeting quality attribute specifications across a region of process parameter values.  Monte Carlo simulation models are quite flexible for computing such probabilities. But first, one needs to build the Monte Carlo model.  This talk will outline the concepts and quantitative tools needed to build a Monte Carlo model for your process, and then use it to construct an ICH Q8 design space.   In addition, this talk will also touch upon the issue of building a design space when having many quality attributes, a situation which often arises with biopharmaceutical processes.