Upstream and Downstream Strategies to Actively Control Product Quality Attributes

Historically, the strategy for large molecule process development has been centered on the idea that reducing process and raw material variability will lead to products with minimal variability in their quality attributes. In this scenario, the purpose of in-process and final product release testing is to assess and control process variability. In recent years, greater understanding of specific attribute criticality has allowed us to envision processes specifically designed to control critical product quality attributes. This presentation will describe examples where product quality attributes were well understood and strategies for upstream and downstream process design resulted in the production of molecules with appropriate, pre-defined product quality attributes.