The production of monoclonal antibodies (mAbs) demands economical downstream purification process with high purity, yield, and throughput. In contrast to traditional batch based operations, continuous processing through the various purification steps (or downstream unit operations) offers a number of advantages. These include faster overall processing time, lower cost and less storage facilities. In this work, a continuous mAbs purification process has been developed with the use of emerging technologies and single-use, disposable products, such as single-use centrifugation and simulated moving bed (SMB) chromatography.  A single-use anion exchange membrane chromatography step was developed to be part of this continuous process because of its high binding capacity and reduced buffer consumption compared to the traditional batch based process. A case study using this continuous process is discussed and results show significant productivity improvement with the same product quality as compared to batch operation mode.

Implementation of membrane chromatography into continuous antibody purification process

243rd National Meeting (2012)

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