Affinity chromatography is a key technology for efficient purification of both antibody products and therapeutic proteins. In order to further develop and optimize Bayer's immunoaffinity platform, an in-depth study was undertaken to investigate the impact of resin properties such as backbone chemistry, ligand density, porosity and mechanical compressibility. An antibody ligand against a domain shared by several new product candidates was coupled to a variety of state-of-the art commercial resins, such as MAb select backbone, MAb select extra backbone, Actigel, Sepharose FF, as well as a rigid controlled pore glass resin. Ligand densities were varied for selected candidates. Binding capacities and purification performance parameters such as yield, host cell protein clearance and DNA clearance were evaluated, as well as key product quality attributes. Data will be shown on purification of two different product variants of different molecular weight to include the expected variability of future product candidates.

Affinity chromatography of genetically engineered therapeutic protein variants: Impact of resin properties and ligand densities on purification performance

239th National Meeting (2010)

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