Enabling Higher Post Protein A Product Purity Using Novel Chromatographic Clarification
In the recent years, multiple optimizations and advances have been made to the classic antibody generation process to make it scalable, reproducible, and commercially viable. This article describes a strategy to get consistent highly pure products, lower manufacturing costs and improve the process efficiency while maintaining robustness.
The team of experts from Catalent and 3M successfully demonstrate a novel alternative method of chromatographic clarification approach using an anion exchange clarifier 3M Emphaze™ AEX Hybrid Purifier to reduce the DNA down to near the limit of detection at clarification. The result of this DNA reduction produces a step change in the purity of the product eluted off the Protein A column. Unlike other strategies, this approach enables a high degree of DNA reduction in a scalable, flow-through, single use system that is industrially viable and rapidly deployable in a commercial process.