Improved antibody purification process through use of additives
Downstream processing involves multiple unit operations including filtration and several chromatography steps that incrementally increases the purity of the target by exploiting the physical and chemical properties. It is critical for therapeutic monoclonal antibodies to have very high purity with low process related impurities like host-cell proteins (HCPs), DNA, leached protein A and aggregates in order to be administered to patients safely.
We have identified a novel approach to improve impurity clearance efficiency of chromatographic steps by modulating the interaction of target protein and/or impurities with ligands on the resins. Protein A resin with high capacity (PROchievA™ ) or mixed-mode HIC resin (BAKERBOND® Poly Hi-propyl) is used for a capture step and additives are screened to reduce the non-specific binding of impurities. Following IEX steps are optimized to increase the capacity and removal of impurities such as residual HCPs, DNA, charge variants, aggregates and leached protein A.
This presentation was given during BPI Downstream Processing + Viral Safety Digital Week, May 24-27, 2021
Jungmin Oh, Manager - New Product Development