Scaling the production needs from CMC to flexible scale or large-scale fermentation-based production of APIs (like insulin) is a cumbersome endeavor. Even though key operational process parameters have been validated at development scale and common scale up methods have been applied, the variation in space, time, and yield can differ considerably from site to site. This presentation attempts...
Digitalization and especially Digital twins have become a new frontier in the biomanufacturing- and processing industries. The development of these technologies promises to improve lean and intelligent production opportunities within these sectors by addressing model complexities with more data driven and hybrid modeling approaches. These methods employ a tight integration between the digital...