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| Auteurs principaux: | , , , |
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| Format: | Artículo Open Access |
| Publié: |
Wiley
2026
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| Accès en ligne: | https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/bit.70232 |
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- Design Space Assessment of Virus Inactivation in Plasma‐Derived Matrices Establishes a Single Detergent Alternative to TX‐100‐Containing Mixes Johanna Kindermann Cecilie Klausen Michael Karbiener Thomas R. Kreil Biotechnology and Bioengineering ABSTRACT The detergent Triton X‐100 (TX‐100) is a typical component of solvent/detergent (S/D) mixes applied for virus inactivation steps of biomanufacturing processes, yet environmentally unfavorable properties have led to restrictions on its use. Deviron 13‐S9 has recently been described as an eco‐friendly TX‐100 alternative, with powerful virus‐inactivating properties determined in matrices representative of recombinant and some plasma‐derived process intermediates such as cryo‐poor plasma. The present study extends this knowledge via a side‐by‐side comparison of virus inactivation by Deviron 13‐S9, applied as a single detergent, and a traditional TX‐100‐containing S/D mix, in four plasma‐derived matrices, bracketing a broad range of protein concentrations and pH values. Across all conditions, three distinct model/target viruses were rapidly inactivated to below the respective assay detection limit, even at Deviron 13‐S9 concentrations as low as 0.05% (v/v), that is, markedly below the lower limits of TX‐100 concentrations in current GMP processes. In addition, Vaccinia virus, considered as the worst‐case model with respect to detergent‐mediated clearance, was inactivated by Deviron 13‐S9 with similar kinetics as by a conventional, TX‐100‐containing S/D mix. Collectively, these results establish equivalent potency for virus inactivation, at a favorable use of only one detergent versus traditional S/D mixes from a biotechnological efficiency perspective. 10.1002/bit.70232 http://creativecommons.org/licenses/by/4.0/