Monoclonal Antibody Purification:
A Two-Step Approach Using a Strong
AEX-HIC Mixed-Mode Resin
Presenter:

Marian Magdy
R&D Purification Manager,
Minapharm Pharmaceuticals
Monoclonal antibodies (mAbs) increasingly form the majority share of the product pipeline of major biopharmaceutical companies. Challenges in the purification of mAbs include reducing production cost, developing robust processes for both product purity and viral clearance, and integrating upstream and downstream processes. Traditional mAb 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 4A 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. Key Takeaway:
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