Detergents are widely used in the plasma and biopharmaceutical industry for robust and effective inactivation of enveloped viruses. Genentech has established robust virus inactivation conditions in Harvested Cell Culture Fluid (HCCF) utilizing TRITON X-100. However, due to wastewater concerns related to TRITON X-100 and the cost of alternate disposal methods, alternative eco-friendly detergents were evaluated. The robust viral inactivation provided by this step makes it a valuable component of downstream processes by reducing the dependence on viral clearance claims from chromatography columns to meet targets. This presentation describes the work performed to identify and evaluate biodegradable, non-ionic detergents for robust viral inactivation in HCCF. Various aspects related to the implementation of the lead detergent such as robustness testing of viral inactivation behavior, control of foaming, and characterization of raw material variability will also be covered. In addition, a case study describing the challenges and successes with the recent implementation of this eco-friendly detergent in GMP manufacturing will be presented.

Eco-friendly detergent for viral inactivation

251st National Meeting (2016)

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