On-column virus inactivation by solvent/detergent treatment for a recombinant biological product

We present here one approach for the intensification of bioprocesses by applying on-column virus inactivation using solvent/detergent (S/D) treatment during ion-exchange chromatography. The established purification process of a recombinant protein was used as a model to compare key process parameters (i.e., product yield, specific activity, impurity clearance) of the novel approach to the standard process protocol. Additional wash and incubation steps with and without S/D-containing buffers were introduced to ensure sufficient contact time to effectively eliminate enveloped viruses and to significantly decrease the amount of S/D reagents. Comparison of key process parameters demonstrated equivalent process performance. To assess the viral clearance capacity of the novel approach, XMuLV was spiked as model virus to the chromatographic load and all resulting fractions were analyzed by TCID50 and RT-qPCR. Data indicates the inactivation capability of on-column virus inactivation even at 10% of the nominal S/D concentration, although the mechanism of viral clearance needs further investigation.PMID:37516085 | DOI:10.1016/j.biologicals.2023.101693

Source: Biologicals : Journal of the International Association of Biological Standardization - July 29, 2023 Category: Biotechnology Authors: Daniel Polasek Andreas Flicker Christian Fiedler Maria R Farcet Martin Purtscher Thomas R Kreil Source Type: research