Biomanufacturing is at an inflection point. From the outside‑in, macro forces - significant near‑shoring investments over the next 3–5 years, costing pressures, and the need for regional, resilient supply chains - are reshaping where and how we make therapies. From the inside‑out, the need to increase speed to market, rapid advances in digitization including application of predictive and prescriptive maintenance, real‑time release, digital twins and AI, the drive to automated controls while reducing failure rates, along with advancements in new modalities are converging to redefine operations. Together, these forces demand a smarter, more adaptable approach to biomanufacturing. This session will explore the opportunities and hurdles to scale-up science, applying advanced technologies supported by reliable and sustainable supply chain strategies to optimize bioproduction.