Can A Design Space Be Built On Material Attributes Alone?

In April, 2009, the PhRMA Drug Product Technical Group sponsored an industry workshop to explore the practicality and limitations of defining a design space in terms of material attributes rather than process variables. This presentation summarizes and expands on the output of this workshop. A material-attribute design space would be independent of scale and configuration of process equipment and the associated process variables. For this reason, it would be portable in the sense that post-approval changes of equipment scale, nameplate, or location would not require regulatory approval. A hypothetical case study of an immediate release oral tablet is presented to illustrate how such a design space could be constructed and implemented.