Currently there is a need in the industry to explore novel technologies to clarify viral vectors from other impurities originating from host cells and culture media. A step that removes intact cells, cell debris, etc. precedes the traditional method of depth filter used for clarification. This step is commonly performed through conventional centrifugation, disc stack or fluidized bed centrifugation. However, some of these techniques are difficult to scale up and in some cases time consuming making it cumbersome. One of the new technologies that has been investigated is the Sonic Wave based Separator (SWS).<br/>The study involved the clarification of cell debris from viral particle released from mammalian cell culture utilizing the process development scale SWS. Depth filtration before and after SWS were evaluated and used as tools to investigate the performance of the SWS. Some optimization of the run was performed to compare results in addition to the standard operating conditions for SWS. Initial screening of the performance of SWS was evaluated by the turbidity reduction of the harvest feed along with depth filtration. The run achieved a turbidity reduction of 92% at 45 ml/min flow rate and 82-85% NTU reduction at 60 ml/min flow rate. The estimated yield from this experiment was 93% (based on volume). Two different grades of cellulose based depth filters were used to show the potential depth filter area reductions when using the SWS for primary clarification. Post SWS, the material achieved a depth filter area reduction of 4.3-fold as compared to pre-SWS feed. Sterile filtration trial using 0.2um sterilizing grade filter was also done resulting in a throughput of 1300L/m with the trial terminated at 12 psi. These preliminary results show that SWS can potentially be a simple, scalable and robust technology to replace existing clarification techniques.

Evaluation of sonic wave based separator for clarification of viruses from mammalian cells

2019 Spring National Meeting

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