Developing Your Biologic with Technology, Process Strategy, and Market Strategy in Mind

Early-phase clinical programs typically rely on fed-batch manufacturing, but growing confidence in continuous processing is enabling companies to plan long-term supply strategies earlier in development. Continuous manufacturing is well suited for unstable molecules, perfusion processes, and mid-scale production where agility, market responsiveness, and productivity gains are critical. Fed-batch remains dominant at very large scales. Charles Heise, Associate Director, Bioprocess Strategy & Development, at FUJIFILM Biotechnologies, explains that the main barriers to broader adoption are not technical limitations but regulatory planning, operational experience, and industry confidence. He also highlights the importance of working with experienced, innovation-driven CDMO partners.