Virodex™ – For viral inactivation and cell lysis applications for bioprocessing

Are you utilising viral inactivation and cell lysis techniques in your bioprocessing applications?

We’re introducing our new range of detergents specifically designed to support the key steps in your biomanufacturing processes.

The Virodex™ range for viral inactivation and cell lysis is REACH-compliant, compendial, sustainable, and has been optimised for use in biomanufacturing of recombinant proteins, blood fractionation products, viral vectors, and more.

We, Croda, maintain the highest level of safety and manufacturing standards, to ensure our offerings are cGMP EXCiPACT manufactured, compliant to the corresponding Pharmacopeial monographs, and much more.

What is the Virodex™ range of detergents?

The Virodex™ range offers two products, TXR-1, and TXR-2. Both products have been shown to have equivalent or better performance in virus inactivation and cell lysis applications than Triton™ X-100 and three other marketed products available today. The Virodex™ products are non-denaturing detergents that show excellent protein compatibility and high batch-to-batch consistency. These qualities make Virodex™ TXR-1 or TXR-2 excellent options to consider incorporating into your existing or new biomanufacturing processes.

Snapshot of available data:

To assess the performance of our product range, we compared its performance to three virus inactivation products available on the market today and Triton™ X-100, in multiple tests relevant to biomanufacturing processes:

• Viral inactivation – potency and kinetics
• Cell lysis of CHO-K1 and HEK293T cells
• Protein compatibility.

Findings show that Virodex™ TXR-1 and TXR-2 had equivalent performance to Triton™ X-100 in all comparative tests and performed better than the other marketed products in virus inactivation tests.

Additional COA testing is included in our specifications: bacterial endotoxin, Total Aerobic Microbial Count (TAMC), and Total Yeast and Mould Count (TYMC) to support use in sterile manufacture.

Virodex

Choose Virodex™ for your bioproduction needs

Despite Triton™ X-100 being a widely used detergent for viral inactivation and cell lysis in biopharma, the substance group it belongs to (phenol ethoxylates) was added to the Candidate List of Substances of Very High Concern (SVHC) of the REACH (Registration, Evaluation and Restriction of Chemicals) Regulation in 2012 by the European Chemicals Agency1.

With a sunset date of January 4th 2021, its use and sale in the EU was banned, except for those with an exemption certificate². The time for applying for exemptions has now passed.

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.

Our Virodex™ range offers two solutions: TXR-1, and TXR-2.

Read the full article here

Source: Croda, website https://www.crodapharma.com, https://www.crodapharma.com/en-gb/drug-delivery-solutions/explore-by-platform/protein-delivery/introducing-virodex#virodex, Croda bochure