HCPs are a highly diverse range of proteins. While some HCPs can be degradative to the product itself, others could induce an unwanted immune response compromising the safety and efficacy of the biologic. The majority of host-cell proteins are removed through multiple chromatography steps and filtrations; individual host-cell proteins can be more challenging and can be carried through even into bulk drug substance. Hence reducing them to the generally accepted level can be challenging.<br/>A promising strategy to achieve this goal is to integrate a precipitation step during harvest operations. In this talk, we discuss caprylic acid (CA) precipitation, as a promising tool to increase clearance of potential critical HCPs and therefore reduce the burden on the subsequent purification and filtration steps. Operational conditions (e.g. pH and caprylic acid concentration) were evaluated with respect to yield, impurity clearance (e.g. HCPs) and impact on product quality attributes (e.g. HMW, LMW, charge pattern). Precipitated cell culture pools were further purified to investigate the impact on following purification steps. In summary, 4 different IgGs were used for this study to demonstrate the applicability of this technique as valuable option for increasing impurity clearance in mAb processes.

Evaluation of caprylic acid precipitation as a tool to increase clearance of potentially critical host cell proteins

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.