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

The increasingly pressing demand of novel bio-drugs (e.g., gene therapies) with unprecedented levels of personalization, has put a remarkable pressure on the traditionally long time required by the pharma R&D and manufacturing to go from design to production of new products. In fact, practitioners are increasingly moving away from the classical paradigm of large-scale batch production to continuous biomanufacturing with flexible and modular design, which is further supported by the recent technology advance in single-use equipment. In contrast to long design processes, low product variability (one-fits-all), and highly rigid systems, modern pharma players are answering the question: can we bring design and process control up to the speed that novel production technologies give us to quickly set up a flexible production run? In this tutorial, we present key challenges and potential solutions in terms of new bioprocess modeling and control strategies for integrated design and manufacturing of next generation bio-drugs.