Separation of antibody IgG201 by an aqueous two-phase system with recyclable pH-responsive polymers

Since their clinical application success, therapeutic monoclonal antibodies (mAbs) have been playing important roles in the treatment of many diseases. A significant obstacle to reducing antibody drug costs is reducing the use of expensive materials in the purification manufacturing process. New technologies, such as aqueous two-phase systems (ATPSs), are an option to solve this problem. In this study, a recyclable aqueous two-phase system was developed. Two pH-responsive polymers were synthesized and characterized. The phase-forming polymers and salt concentrations, system pH, and temperature were studied. Finally, under conditions of 6% P-MDB3.36 with 20 mmol/L sodium acetate and 30 mmol/L Na2SO4 at pH 5.5, the recovery of target monoclonal antibody IgG201 was 94.4 % and partition coefficient was 8.7. The purity was 92.2 %, as determined bysize exclusion chromatography (SEC). The pH-sensitive polymers in this ATPS can be recycled near their isoelectric point.

Automated summary

A recyclable aqueous two-phase system was developed using pH-responsive polymers to assist in the recovery of therapeutic monoclonal antibodies, improving both recovery rate and purity.