Maintaining Consistency Across Batches, Scales, And Sites, Powered By ExcellenS™

Even tightly controlled biologics processes are subject to biological variability and process sensitivity, and small deviations can affect regulatory confidence, supply continuity, and timeline adherence.

Samsung Biologics presents ExcellenS™, its standardized operational framework, as the basis for aligned execution across a global manufacturing network that includes the Rockville Campus in the U.S. The featured example is a client process scaled and transferred from 5,000 L at Bio Campus I to 15,000 L at Bio Campus II, with side-by-side data on harvest, cell viability, titer, glycosylation profile, and monomer percentage.

It also covers the elements behind site alignment: plant equivalency, standardized design, predictive simulation with digital twin and CFD modeling, and integrated real-time data systems. Contact the team to discuss how the framework could fit your project.