loading page

Demonstrating the Effectiveness of an Alternative to Triton™ X-100 for Detergent-Mediated Viral Inactivation in Biomanufacturing
  • +3
  • Kakolie Banerjee,
  • Alice Antonello,
  • Sandra Johnson,
  • Anja Licht,
  • Almut Rapp,
  • Corine Miller
Kakolie Banerjee
EMD Millipore Co Bedford

Corresponding Author:[email protected]

Author Profile
Alice Antonello
Merck KGaA
Author Profile
Sandra Johnson
EMD Millipore Co Bedford
Author Profile
Anja Licht
Merck KGaA
Author Profile
Almut Rapp
Merck KGaA
Author Profile
Corine Miller
EMD Millipore Co Bedford
Author Profile

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.
12 Jul 2024Submitted to Biotechnology and Bioengineering
19 Jul 2024Submission Checks Completed
19 Jul 2024Assigned to Editor
19 Jul 2024Review(s) Completed, Editorial Evaluation Pending
22 Jul 2024Reviewer(s) Assigned
15 Aug 2024Editorial Decision: Revise Major
26 Sep 20241st Revision Received
07 Oct 2024Submission Checks Completed
07 Oct 2024Assigned to Editor
07 Oct 2024Review(s) Completed, Editorial Evaluation Pending
24 Oct 2024Reviewer(s) Assigned