Abstract
Detergents are routinely included in protein purification processes to inactivate enveloped viruses that may arise from adventitious or endogenous contamination. The detergent Triton X-100 (TX-100) has been widely used as part of the production process for therapeutic proteins. However, recent ecological studies indicate that TX-100 and its metabolites detrimentally impact aquatic organisms, thus alternative detergents for viral inactivation are required. The overall aim of this study was to identify one or more detergents that are a suitable replacement for TX-100 in the viral inactivation step. In stage one, 16 potential alternatives were identified and screened against TX-100 using multiple criteria such as solubility, feasibility of virus inactivation, critical micelle concentration, and storage conditions. The multi-criteria decision analysis (MCDA) methodology was used to identify four candidates for the second stage assessment. In stage two, a detailed evaluation was undertaken and two candidates C16-AO, and C11/15-sEO9, were found to be practical alternatives to TX-100 for use in protein therapeutic production processes for inactivating enveloped viruses. In addition, C13-EO8 demonstrated good viral inactivation capability and warrants further investigation in detergent clearance and impact on product quality.
Published Version
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