Demonstrating the Effectiveness of an Alternative to Triton™ X-100 for
Detergent-Mediated Viral Inactivation in Biomanufacturing
Abstract
Detergent-mediated viral inactivation is an important process step for
ensuring viral safety of parenteral biotherapeutics, including plasma
proteins and monoclonal antibodies (mAb). The conventional Triton™ X-100
detergent has ecological toxicity concerns and REACH classification that
mandate replacement in the biopharmaceutical industry. Criteria for a
replacement detergent include viral inactivation efficacy, acceptable
safety and biodegradation profile, process removal and quality suitable
for parenteral drug product manufacturing. A non-ionic, C11-15 secondary
alcohol ethoxylate, Deviron ® 13-S9 detergent, has
been demonstrated to meet the necessary requirements for detergent
performance. Benchmarking studies with Triton™ X-100 demonstrate
comparable performance with a panel of enveloped viruses in multiple
matrices, including human IgG, clarified cell culture harvest, and
fractionated plasma. Deviron ® 13-S9 detergent
demonstrated viral inactivation efficiency comparable to or better than,
Triton™ X-100 detergent, achieving > 5 log reduction values
(LRV). Critical micelle concentration (CMC) was determined across
different temperatures and media. Deviron ® 13-S9
detergent was demonstrated to be readily biodegradable according to OECD
301B guidelines. Effective removal with typical chromatography processes
used in downstream purification was confirmed. These findings support
Deviron ® 13-S9 detergent as a viable alternative to
Triton™ X-100 detergent, ensuring robust viral inactivation,
environmental compatibility, and alignment with regulatory requirements.