Enabling Higher Post Protein A Product Purity Using Novel Chromatographic Clarification
Summary: 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.