Facility Design — Balancing Stainless-Steel, Single-Use, And Continuous Approaches To Manufacturing

By Madhu Raghunathan

The key factor driving change in today’s pharmaceutical industry is the impressive rise in biologic drugs, which now make up 25 percent of the total pharmaceutical market.¹ Companies targeting biologics face a new frontier in development and manufacturing, as these drugs are complex, diverse, and difficult to produce. This complexity and the emergence of biosimilars are driving cost efficiency, as well as promoting the adoption of more modern bioprocessing technologies. Compounding the challenge of biologic drug development is that manufacturers must gain approval from regulatory agencies on not just the biologic drug itself, but also the process used to manufacture it. This makes changing the production process after a drug and its process are approved both risky and costly, which is why some biopharmaceutical manufacturers are hesitant to try new and potentially more efficient technologies. Nonetheless, manufacturers may have to embrace change to remain competitive in this growing market. Several modern downstream technologies available today can improve efficiency and even quality, such as single-use technology (SUT). It is important to understand the benefits of each these options and how they can be used to forge a path toward bioprocessing excellence.