Batch vs. Continuous, Scale-Up & Scale-Down, Case Studies

Early-stage process development to introduce new molecules or active materials is often performed in a batch mode and a small scale. These process steps typically include synthesis, separation, and purification. However, when the development team explores the commercial viability of the new process technology, the decision of batch vs. continuous operating mode and a combination of scale-down from feasible commercial embodiments and risk-managed scale-up is critical. Depending on the process technologies and materials, many factors and potential tradeoffs need to be considered when identifying the most optimal operation mode and scale factor. Examples include a reduced number or right-sizing of experiments and possibly step-skipping, process safety, complexity, product form & quality, production volume, manufacturing cost, investment & physical footprint, production time, location, waste generation, sustainability, and commercialization timeline. This session will cover case studies on how the differences in the benefits & risks for these aspects impact the batch vs. continuous, scale-up & scale-down process decision, and methodologies for accelerated process scale-up.