CONTINUOUS EXTRACTION STRATEGIES FOR MONOCLONAL ANTIBODIES: FROM MACRO- TO MICRO-SCALE

摘要

Aqueous two-phase extraction (ATPE) have shown to be a valuable option for the downstream processing of biopharmaceuticals, combining a high biocompatibility and selectivity with an easy and reliable scale up. Moreover, ATPE can overcome some of the technical drawbacks currently encountered using established purification platforms, such as batch operation, diffusional limitations and scale-related problems. We have developed a continuous ATPE process incorporating three different steps (extraction, back-extraction and washing) for the capture of monoclonal antibodies (mAbs). The ATPE process was set up and validated in a pump mixer-settler battery and successfully applied to a Chinese hamster ovary and a PER.C6® cell supernatant.