Looking to the Future in Continuous Pharmaceutical Manufacturing

This presentation describes the motivations, challenges, and opportunities in continuous pharmaceutical manufacturing. Some of the motivations are particularly intriguing, such as semicontinuous and continuous-flow unit operations that have the potential to have order-of-magnitude higher controllability and/or are much easier to scale up than batch and semibatch processes. Theoretical, computational, and experimental results are provided as evidence of the potential opportunities of continuous-flow pharmaceutical manufacturing operation. One of the conclusions of reviewing such unit operations is that they can look and operate very different from the batch and semibatch unit operations currently used in the pharmaceutical industry.

Example unit operations are drawn from the published literature, which include both journal papers and patents from various academic and industrial research groups. The presentation will also review and comment on the application of Quality-by-Design methodologies to pharmaceutical manufacturing. Of particular interest is the generation of design spaces, and the pros and cons of different approaches. In particular, it is shown that many of the methods for the construction of design spaces that have been proposed in the literature are useless from a control or operations point of view.