(317f) Case Study: Model-Based Chromatography Process Development

The biopharmaceutical industry continues to explore options for improving process development efficiency to meet the needs of today’s fast and competitive market.  Technologies like platform utilization, high throughput screening, and computer simulation continue to advance the industry, but a strategy that successfully balances process efficiency with speed to market will likely require a synergistic application of these technologies.  In recent years, the sophistication of the general rate model for chromatography has advanced considerably.  Utilizing these models for chromatography process development lends itself favorably to high throughput isotherm measurement techniques. We present a case study for the application of a model-based approach to chromatography process development and characterization for a commercially relevant monoclonal antibody.