High Aggregate Levels with Engineered Monoclonal Antibodies: An Innovative Approach to Addressing the Challenge

Advancements in modern engineered monoclonal antibody (mAb)–based therapeutics has led to a range of innovative and effective biomolecules and higher titers. However, the production process can result in high levels of aggregation and other product related impurities, posing downstream purification challenges.  Traditional chromatography methods for aggregate removal are limited in their operating range and effectiveness, often resulting in low recoveries or poor process economics.

This article presents a design of experiments (DoE) study to investigate and optimize the performance of an innovative mix-mode chromatography resin used in flow through mode for the removal of high levels of aggregates in mAb feeds.   Monomer recovery and aggregate levels are presented for different chromatography conditions, as well as different loading densities.  Significant clearance of other process-related impurities such as hard-to-remove host cell proteins (HCPs) are also demonstrated.

Read this article to discover how Thermo Scientific™ POROS™ Caprylate Mixed-Mode Cation Exchange Chromatography Resin can be used in flow through mode to efficiently and effectively remove high levels of aggregates, leached protein A, and HCPs in modern mAb-based therapeutic production processes.

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