(641f) Case Study: Simulation-Based Process Optimization for a Monoclonal Antibody Cation Exchange Step

Authors: 
Larsen, T., Amgen Inc.
Todd, R., Amgen Inc.
Hunt, S., Amgen Inc.
Sharma, A., Amgen Inc.,

Case Study: Simulation-Based Process Optimization for a Monoclonal Antibody Cation Exchange Step.

The biopharmaceutical industry continues to explore options for improving process development efficiency to meet the needs of today’s fast and competitive market.  This presentation discusses the application of computer simulation to the optimization of a monoclonal antibody cation exchange (CEX) chromatography step.  The chromatography simulation utilizes the General Rate Model for chromatography in combination with a Steric Mass Action binding isotherm to predict process performance over a range of operating conditions.   Simulation was used to optimize the process throughput while maintaining acceptable product purity.    The results suggest that application of computer simulation has the potential to significantly reduce the time and experimental resources required for process optimization.

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