Respiratory syncytial virus (RSV) is the most important unmet pediatric vaccine need in developed countries. Our RSV F subunit vaccine candidate is an engineered recombinant RSV fusion glycoprotein (F) expressed by CHO-K1 cells. CHO cell-expressed protein has the potential issue of virus contamination from endogenous retrovirus particles and adventitious agents. Therefore, virus clearance in RSV F processing is very important to mitigate the risk of virus contamination. We studied various virus clearance technologies, including detergent inactivation, ion exchange chromatography, pH inactivation, membrane chromatography, and nanofiltration. For different technologies, RSV F protein stability and recovery were studied and the virus clearance capability was evaluated by virus spiking study. The virus clearance steps were chosen and integrated into the RSV F protein purification process. The total process achieved high log reduction values for the model viruses and thus mitigated the risk of virus contamination in this new vaccine candidate.

Virus clearance study for RSV F vaccine processing

243rd National Meeting (2012)

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