Scalable Solutions Through kojoX™: Building A Biomanufacturing Ecosystem For Supply Agility Starts As Early As Cell Line Development

By Charles Heise, Ph.D., Associate Director, Bioprocessing Strategy & Development, FUJIFILM Biotechnologies

Global biopharmaceutical demand is rising faster than current capacity, driving the need for manufacturing ecosystems that do more than add new facilities—they must operate as fully standardized, connected networks. A harmonized operational model with aligned processes, equipment, and digital systems enables seamless technology transfer, reduced regulatory burden, and reliable global supply. Central to this approach is a high-productivity cell line development platform designed for rapid timelines, strong titers, and flexibility to switch between fed-batch and perfusion without re-engineering the expression system. This accelerates movement into clinical supply while maintaining adaptability for uncertain market dynamics.

A standardized, unit-operation-agnostic purification system adds further agility, supporting batch, continuous, and hybrid workflows and enabling scale-up or scale-out with consistent control strategies across all phases. Unified upstream and downstream technologies allow developers to leverage shared data, streamline validation, and transfer processes smoothly across facilities ranging from single-use bioreactors to 20,000 L stainless-steel systems. With modular, scalable capacity distributed across a global network, developers can adjust production rapidly in response to clinical outcomes, fluctuating demand, and diverse therapeutic modalities. The result is a resilient, future-ready biomanufacturing ecosystem that improves speed, reliability, and supply agility.