5/31/2023 0 Comments What is the meaning of doeWatch Recorded Webinar: Robust Optimization Made Easy Optimize Experimentation Processes with DOE Build quality into your process as outlined by ICH Q8, Q9, Q10. Create reproducible and documented processes.įollow the Quality by Design (QbD) approach. Identify factors that may reduce material consumption and waiting time.įulfill regulatory compliance. Reduce the number of experiments you need to perform by increasing your knowledge about your process. Identify critical process parameters (CPPs) that may be sensitive to small factor changes or which need to be controlled to achieve robustness. Validate and characterize process stability and robustness. Define regions where product quality is assured. Select the right factors and ranges of process parameters to find process optimums, such as pH range and temperature ranges that optimize a certain key performance indicator (KPI), such as titer.īuild a design space. For example, evaluate media composition against total cell density (TCD) and viable cell density (VCD). Investigate many process parameters and their cause-and-effect relationships. DOE Shortens Time to Market and Increases Process RobustnessĭOE helps support R&D and production in many critical ways. DOE helps scientists and process specialists confidently create robust and reproducible processes that shorten the time to market for (bio)pharma products.
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