Detergent Virus Inactivation in Chromatography Systems

Detergent treatment is a widely utilized virus-inactivation step in therapeutic protein manufacturing to safeguard products. Traditionally, this operation is performed in an incubation vessel in batch mode. In this investigation, a methodology was developed to enable virus inactivation via a post-load, detergent-containing wash within a bind-elute chromatography process. Application of the non-ionic detergent Laureth 9 during the post-load wash achieved more than 4 logs of retrovirus inactivation. Chromatography control experiments conducted without detergent resulted in negligible virus inactivation. Simultaneous measurements of virus infectivity and genome copies distinguished the contributions of detergent-driven net virus inactivation from those of separation-driven net virus removal. These results establish a robust and simplified alternative approach for virus inactivation in therapeutic protein manufacturing.