A Swiss start-up is hoping to lower the costs of biologics development by adapting a quality control technology to the pharmaceutical industry. The new light obscuration instrument for sub-visible particle testing during product formulation is Bionter’s first product and will be launched between May and August.

“The light obscuration instrument is the first in a family of products, and the unique thing is that it doesn’t consume samples during testing,” explains Bionter’s CEO, Tobias Werk, PhD. “During formulation development, light obscuration alone consumes thousands and thousands of samples, and the material alone easily exceeds $1,000 for a single sample. So, by making it non-destructive, you open lots of opportunities to get insights faster and lower the cost of development.”

According to Werk, light obscuration technology is an established technique for sub-visible particle testing in the formulation phase of biologics development. However, because the technology was adapted from aerospace, he says it really wasn’t configured to the specific needs of the pharmaceutical industry.

“Light obscuration technology was developed around 1960 and was adopted into pharmaceutical [research] as a requirement because it could substitute for microscopy,” he explains. But, Werk says, since the technology has largely remained unchanged, except for the substitution of a laser for bulbs in the 1980s, this inspired him to set up Bionter in 2020 with the aim of creating tailored technologies for the pharma industry.

The new light obscuration instrument avoids destroying the sample by incorporating a drying step into the analytical process, he points out, which prevents contamination dilution as different samples are moved through the system.

Werk automated the instrument to allow operators to leave the equipment and changed the fluidics to deal with the viscosities for high-concentrated protein formulations and other biologics.

The new instrument, he notes, also didn’t require specific regulatory approval. “Our method uses off-the-shelf light obscuration technology, so it still conforms with regulations,” he says.

Werk is scheduled to speak about his technology this week at the Bioprocessing Summit Europe.

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