<br/>Host cell proteins (HCP) are a process-related impurity common to biological therapies that have the potential to elicit an immune response in patients and, because of this, regulatory bodies require &lt;100ppm HCP in the drug substance. Downstream purification steps and, in particular chromatography resins, are heavily leaned on to accomplish the necessary clearance. HCP can be a complex process-related impurity in that there can be subtypes with differences in chemistry that can present a challenge to clearance using process-platform chromatography resins.  Purification processes are at a point where depth filtration is commonly used for haze reduction and/or impurity clearance with product, buffer conditions commonly at a neutral pH and a conductivity of &lt;10mS/cm. This work screened several media types e.g. cellulose diatomaceous earth, activated carbon, and synthetic media at a pH of 6.0 with varying conductivity to maximize HCP clearance and product yield. Millistak+<sup>®</sup> HC X0SP, a synthetic media depth filter, at elevated conductivity, was identified as the optimum depth filter.<br/>

Clearance of host cell protein at elevated conductivity through synthetic depth filtration media during downstream processing

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.