Biopharma Industry Develops Alternatives to Banned Chemical

The banning of a chemical in the EU has worldwide implications for biopharmaceutical manufacturing, but, thankfully, the market already offers high-performing alternatives.

That was the message of a talk given at BioProcess International last month by Wenyi Yee, PhD, research manager at Croda and her colleague, lead application scientist, Garima Sinha, PhD.

“A key takeaway is that replacing Triton™ X-100 is inevitable, and it’s definitely worth looking into alternatives,” Sinha explains.

“Even though it may seem only one continent is affected, in the pharma world, anything that affects one region is a global problem.”

Triton X-100 is a detergent used to prevent viral contamination during the manufacture of biologics and plasma-derived products. It was banned by the EU in 2021 due to its potential impact on aquatic life.

Initially, according to Sinha, companies outside the EU were reluctant to seek alternatives as they’d often spent decades optimizing Triton X-100-based processes.

“It’s not that companies [didn’t] want to change, but change isn’t easy, especially when a well-established process needs revisiting,” she says.

The industry is now working on alternatives to Triton X-100 for removing viral contamination and to lysing cells during the production of complex proteins like mAbs, says  Sinha.

Alternative techniques include using a different detergent or exposing the cells to low pH, which—according to Sinha—risks protein aggregation.

“It might be a biased opinion, but I think detergents are a better option because they’re more robust compared to pH change,” she says.

In preparation for the ban, Croda went through their catalog of specialty chemicals and found two chemicals that performed equally as well, or better, than Triton X-100.

The company launched Virodex™ TXR-1 and TXR-2 last year, she says.

Customers are now trialing the products, says Yee, who explains that independent data has been published showing Virodex™ performs as well or better than Triton X-100 in their processes.

Croda says they’ve also developed analytical techniques to detect Virodex™ at the parts per billion (PPB) levels to ensure their products do not contaminate the final drug. They have been working with customers on analytical testing of their samples, she explains.