Portable Quality By Design
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Using the Design of Experiments method is essential for generating a response surface for a complex unit operation or over several integrated steps. However, the analysis applies only to the system tested within narrow conditions and cannot be applied to other processes. In this presentation Scott Rudge, SVP, Product Development, Bradmer Pharmaceuticals, demonstrates that engineering equations are well suited for describing performance in simpler unit operations, and can be used to make exact predictions on process performance during scale up and transfer. Rudge discusses making engineering analysis “portable” by measuring the appropriate engineering parameter (such as mass transfer coefficient, rather than dissolution time.) To make it applicable to multiple processes, as well as multiple scales.
Presented at IQPC's PAT and QbD for Biopharmaceuticals, May 2010.