New non-chromatographic affinity matrices for antibody purification

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Antibodies form part of the most growing segment of pharmaceutical industry. Based on optimized production processes with increasing product titers the challenge for the subsequent purification process is also growing, which can account for up to 80% of the total costs. By technical limitations, the volumes of chromatography columns cannot be extended. Higher capacity and better process stability of the chromatographic media are becoming increasingly important. At the platform process with classical Protein A based affinity chromatography both parameters reached their limits: New alternatives have to be found. Since the antibodies are purified by affinity ligand in just one step with > 95 % purity and high yield, no new process could prevail without affinity ligands.Based on the previously unrivaled affinity ligands the challenge of limiting parameters will be solved by choosing a non-chromatographic matrix in combination of new high-capacity base-stabilized protein A-based ligands.By comparison of nonporous matrices and classical chromatographic media it will be shown that mesopores have not only a negative impact on mass transfer limitation but also on the elution conditions and aggregation behavior of antibodies. Because of their simple processability the choice of carrier materials falls on two different types of biocompatible magnetic particles of different size (micro / nano). Depending on the size, they have as much or even double specific surface area with the potential to bind more antibody molecules per carrier unit and to set a new benchmark in protein purification. Additional, magnetic nanoparticles are cheaper and simpler to produce than microparticles and chromatographic media.