This presentation addresses the challenges and opportunities associated with the development and scale-up of manufacturing processes for complex new biotherapeutic modalities. Beyond the recognized need for cutting-edge bioprocess engineering, we highlight the critical importance of industrialization – enabling biology, including manufacturable product structures, high potency, and optimized cell lines. Several examples of recent creative solutions will be presented. We will also review the latest bioprocessing methods and tools that, in synergy with the above mentioned biological advances, will deliver dramatically higher productivity, lower cost, and broader patient accessibility.