A Two-Step Approach Using A Mixed-Mode Resin For mAb Purification

Monoclonal antibodies (mAb) increasingly form the majority share of the product pipeline of major biopharmaceutical companies. Challenges in the purification of monoclonal antibodies (mAbs) include reducing production cost, developing robust processes for both product purity and viral clearance, and integrating upstream and downstream processes.

Traditional monoclonal antibody purification platform include three chromatography steps. Protein A chromatography is first used for capture of the product followed by two chromatography steps to remove host-cell proteins, DNA, charged variants, and aggregates.

Alternatively, a well-optimized chromatography step with Nuvia™ aPrime Media, a mixed-mode chromatography resin, can eliminate an entire step of the process, allowing the development of a two-step strategy following capture using protein A. This two-step strategy decreases production costs significantly by reducing process time, buffer consumption, media costs, while at the same time increases product yield.

Speaker: Marian Mady, R&D Purification Manager, Minapharm Pharmaceuticals Egypt