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The increasingly pressing demand of novel drugs (e.g., gene therapies forpersonalized cancer care, ever evolving vaccines) with unprecedented levels ofpersonalization, has put a remarkable pressure on the traditionally long timerequired by the pharma R&D and manufacturing to go from design to production ofnew products. The revolution has already brought important changes in thetechnologies used within the industry. In fact, practitioners are increasinglymoving away from the classical paradigm of large-scale batch production tocontinuous biomanufacturing with flexible and modular design, which is furthersupported by the recent technology advance in single-use equipment. In contrastto long design processes, low product variability (one-fits-all), and highlyrigid systems, modern pharma players are answering the question: can we bringdesign and process control up to the speed that novel production technologiesgive us to quickly set up a flexible production run?  In this tutorial, we present key challenges and potential solutions from theworld of operations research that can support answering such question. We firstpresent technical challenges and novel methods for the design of nextgeneration drugs, followed by the process modeling and control approaches tosuccessfully and efficiently manufacture them.

From Discovery to Production: Challenges and Novel Methodologies for Next Generation Biomanufacturing