Therapeutic monoclonal antibodies (mAbs) are a major product class in the biopharmaceutical industry. They are expected to be a source of new therapeutics for many years to come. Increased mAb expression levels developed by upstream scientists demand that resins with higher binding capacities are also created . These resins are necessary because the batch titers from the production of monoclonal antibodies place increased emphasis on the capacity of the downstream purification process.  Protein A affinity chromatography most often serves as the capture step. Protein A capture is typically the most expensive step in the downstream process. This leads to a definite need for a high capacity Protein A resin to work with today's higher bioreactor titers. The newly developed TOYOPEARL AF-rProtein A HC-650F affinity chromatographic resin is designed to serve the demand. This novel resin utilizes a recombinant, alkaline stable Protein A variant obtained from a third party vendor. Pressure-flow profiles of TOYOPEARL AF-rProtein A HC-650F resin at various column diameters show excellent physical characteristics of the resin indicating that the resin is amenable to large scale processes Preliminary studies also demonstrate higher capacities at reduced residence times compared to other Protein A resins. The overall antibody yield and aggregate clearance will also be presented. The chemical stability (0.1 mol/L) of the recombinant Protein A resin is excellent and indicates it can be used for many cycles in a standard purification process which will also reduce the cost of this important capture step.

Characterization of a newly developed high capacity alkaline resistant recombinant protein A resin

247th National Meeting (2014)

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