Virodex™: exploring our innovative solution to the Triton™ X-100 ban

Triton™ X-100 is a widely used non-ionic surfactant and emulsifier, with a range of applications including viral inactivation, cell lysis and protein solubilisation. Triton™ X-100 belongs to the substance group Phenol ethoxylates which are considered to be hazardous to the aquatic environment and a known endocrine disruptor¹. As a result Phenol ethoxylates were first added to the Candidate List of Substances of Very High Concern of the REACH (Registration, Evaluation and Restriction of Chemicals) Regulation in 2012 by the European Chemicals Agency². In 2017 the European Parliament approved the REACH vote to place Triton™ X-100 onto Annex XIV of the REACH regulation. Its sunset date was set as January 4th 2021, banning its use and sale in the EU except for those with an exemption certificate³.

For those who have previously relied on Triton™ X-100 as a surfactant or detergent in their manufacturing processes there is now an urgent need to find a suitable replacement, now that the time for applying for exemptions has passed. One of the biggest challenges to finding an appropriate, environmentally friendly replacement for Triton™ X-100 is to find an alternative that offers equivalent (or improved) performance with similar properties to minimise impact on manufacturing processes. Any alternative must possess good water solubility, ease of detection by analytics and effective removal by purification processes, all while having no adverse effect on sensitive biomolecules. This is a challenging task to achieve, but Croda Pharma are proud to announce the launch of Virodex™!

Learn about our Virodex™ range of products

Our Virodex™ range of product offerings for viral inactivation and cell lysis are REACH-compliant, compendial compliant, cGMP EXCiPACT manufactured, sustainable chemicals that have been optimised for use in the biomanufacturing industry for uses in recombinant proteins, blood fractionation products, viral proteins, viral vectors including AAVs, and more.

Under our Virodex™ range, we currently offer two distinct, well-studied chemistries:

• Virodex™ TXR-1
• Virodex™ TXR-2

Visit our dedicated Virodex™ page for more information.

Triton is a trademark of The Dow Chemical Company or an affiliated company of Dow.

*Comparative data is available upon request.

References:

1. Substance information ECHA. Available at: https://echa.europa.eu/substance-information/-/substanceinfo/100.123.919 (Accessed: 15 June 2023).
2. Candidate list of substances of very high concern for authorisation (2012) ECHA. Available at: https://echa.europa.eu/candidate-list-table/-/dislist/details/0b0236e1807db570 (Accessed: 19 May 2023).
3. Annex XIV Authorisation list (2022) ECHA. Available at: https://www.echa.europa.eu/authorisation-list (Accessed: 19 May 2023).