Application Note

Polishing Of Monoclonal Antibodies Using Capto™ S ImpAct

Source: GE Healthcare Life Sciences

Capto S ImpAct chromatography medium (resin) is a strong cation exchanger (CIEX). The medium is designed for the polishing steps of monoclonal antibodies (MAbs) and a wide range of other biomolecules. In this study, the binding capacity for a MAb and the efficiency in the clearance of impurities using Capto S ImpAct in bind-and-elute mode were evaluated. This study was performed according to the regulatory initiative quality by design (QbD). A wide experimental space was screened with high-throughput process development (HTPD) methodology, followed by an optimization within a narrower region using a design of experiments (DoE) approach. Even at high loading levels of MAb (up to 80 mg/mL medium), the results showed good resolution between monomer and aggregates at a high monomer recovery.