The RABBIT Jumps Ahead, Rapid A BioSMB Biolayer Interferometry Technology

By Thomas Kruse, Fabian Schmitz, and Markus Kampmann, Sartorius

Monoclonal antibodies (mAbs) have become essential in the treatment of a wide array of severe diseases, including cancer, infections, autoimmune disorders, and inflammatory diseases. Their high specificity, potent activity, and fewer side effects compared to conventional drugs have led to a continuously growing market for mAbs. Advances in the upstream production process, such as achieving higher mAb titers, have shifted the bottleneck in mAb production to the downstream process (DSP). As a result, there is a growing demand for DSP process intensification technologies to address manufacturing bottlenecks.

Continuous multi-column chromatography (MCC) offers several benefits, such as increased productivity, reduced buffer consumption, and lower production costs, all within a smaller equipment footprint. However, MCC processes typically rely on predefined loading volumes and flow rates, which necessitate several assumptions. These include maintaining a constant flow rate, knowing the mAb concentration of the feed solution, ensuring all columns have the same dynamic binding capacity (DBC), and assuming the DBC remains constant throughout the process.

Explore how overcoming these challenges may be possible through dynamic loading based on breakthrough detection of the mAb.