A Science and Risk-Based Approach to Design Space Drug Product Development

Fundamental to the Quality by Design approach is building a high degree of process understanding to ensure critical quality attributes of the final product are consistently met. Providing a foundation for this process understanding comes from a design space, a well defined domain of material and process conditions within which product quality can be predicted and controlled based on identified risks. Based on scientific principles and accounting for risks to quality, a design space was developed at the pilot scale for a fluid bed drug product by using design of experiments (DOE) approach. The use and applicability of this design space upon process scale-up will be discussed.