Use Of Design Of Experiments Screening To Select Resins For Monoclonal Antibody Purification

Chromatography is integral to downstream purification success. Given the number of factors that contribute to chromatographic separation, the use of design of experiments (DOE) is necessary to explore and create a robust design space.

When designing purification workflows and handling chromatographic conditions, researchers must account for variation among mAbs, such as the specific antibody isotype, its isoelectric point (pI), and stability. To be successful, the process must deliver the necessary yield, throughput, efficiency, cost, and be scalable. Selecting the appropriate chromatographic techniques to optimize the downstream process and achieve these objectives can be challenging.

DOE can be used to define all aspects of the separation with greater confidence including:

• The optimal purification conditions for high throughput and yield
• The resin or resin combinations that best purifies the target protein
• Whether an efficient cost-effective process can be established