Monoclonal antibody purification platforms are very well established, and almost all approved mAb purification platforms are using a Protein A capture step. There are however remaining challenges with this technology. Increasing upstream titers can make the Protein A chromatography process step rate-limiting in downstream purification. Protein A chromatography columns are also more prone to bioburden contamination due to heavy impurity load and weak tolerance towards the most efficient cleaning-in-place solutions.<br/> <br/>This presentation will cover the development and evaluation of a novel protein A chromatography resin with significantly increased alkaline stability enabled by protein engineering and a high throughput screening technology using surface plasmon resonance. Design considerations for affinity chromatography resins, and how to balance different properties will be discussed. Data on binding capacity, caustic stability and resin performance, in terms of yield and purity, will be also be presented.<br/>

Development and evaluation of a novel high capacity protein A chromatography resin with significantly increased alkaline stability

255th National Meeting (2018)

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