Over the past decade, continuous and intensified manufacturing for biologics has progressed from concept to practice. Bench-scale experimentation has been followed by pilot-scale demonstration, and now we observe a steadily increasing number of examples of GMP implementation. Sanofi remains committed to the concept of integrated continuous biomanufacturing (ICB), recognizes that this technology offers both short-term benefits as well as long-term strategic value, and accordingly, continues to find opportunities to apply ICB across its product portfolio. This keynote presentation will highlight several ICB case studies involving a variety of situations across the development lifecycle (first-in-human, pivotal production, lifecycle management, etc.) involving a range of modalities (monoclonal antibodies, enzymes, and others). These case studies will demonstrate the multiple benefits of ICB processing (increased productivity, decreased footprint, flexible manufacturing, etc.) as well as highlight new technologies that are required to enlarge the continuous boundary and integrate more downstream purification unit operations. Finally, considerations will be discussed for deciding how, when and where to apply ICB across a portfolio, and how to use both incremental and fundamental strategies to move from a hybrid ICB platform to a fully continuous, end-to-end vision.

Implementation of integrated continuous biomanufacturing across a product portfolio

ACS Fall 2021

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.