The FDA and EMA are actively promoting continuous and distributed manufacturing to improve drug supply chain resilience[14]. In 2023, 30% of new facility approvals were for modular or flexible manufacturing systems. Furthermore, FDA is making Accelerated Approvals Pathways via several breakthrough designations to enable targeted drug products reach masses. In 2023, nearly 80% of FDA-approved drugs were under specialty drugs classification. These regulatory tailwinds motivate Pharma Innovators to discover such specialty drug substances – requiring agile manufacturing to unlock true scale of such targeted products