The production of antibodies and Fc-fusion proteins involves several downstream processing unit operations. The widely used purification template with Protein A chromatography, virus inactivation at low pH, and subsequent ion exchange chromatography steps is mostly able to remove impurities like aggregates, host-cell proteins, and viruses, which could affect the safety and efficacy of the product.<br/>The low-pH elution during Protein A chromatography, as well as during virus inactivation may induce aggregation. Preventing protein aggregation during these unit operations instead of removing the multimeric forms during subsequent polishing steps would be a more efficient strategy. Excipients have shown that they can minimize aggregation levels in the final product formulation.<br/>The objective of this work was to apply excipients, like polyols, in buffer systems, to study their impact on several aspects during Protein A chromatography and virus inactivation. Therefore, a pH gradient system on three different Protein A materials was applied. The results include their effect regarding elution patterns, stabilization of the monomer antibody, host-cell protein removal, and virus inactivation rates, as well as the effect on binding capacities in following cation exchange chromatography.<br/>The results show that the addition of excipients can have a beneficial effect for the purification during Protein A chromatography and virus inactivation, without harming the subsequent chromatographic steps.

Influence of excipients during antibody purification on Protein A chromatography

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.