Matters of Scale: Centralized vs. Decentralized Manufacturing Of Advanced Therapies

By Dalip Sethi, Director of Scientific Affairs, Terumo Blood and Cell Technologies

For cell and gene therapies, centralized manufacturing is structured around manufacturing the cell therapy product at a central hub, where therapy manufacturing processes, namely cell isolation, modification, and expansion to fill/finish, occur. For an autologous therapy, that means a patient’s cells are collected and sent to this hub, transformed into a completed therapeutic, and then returned to a medical facility for administration. In contrast, decentralized manufacturing for these therapies tends to occur in the same location – typically, the cell collection, manufacturing and modification, and infusion as a final drug product take place within the medical facility itself.

Each manufacturing approach has its challenges and opportunities, often centered around five primary variables – logistics, manufacturing, regulation, quality, and labor. To address the major hurdles that accompany each consideration, organizations must prioritize technologies that can automate as much of a process as possible. The value that automated, modular, interconnected technology platforms can provide to both centralized and decentralized models of commercial manufacturing is ultimately tied to the process controls, efficiency, and level of “hands on” interaction required of operators. Reducing human intervention and manual processes in advanced therapy manufacturing is critical to improving an overarching manufacturing paradigm, safeguarding quality, simplifying processes, and improving efficacy through better data and superior consistency.