02/08/2021 | BioRegio STERN Management GmbH | Press

Smart manufacturing for biotechnology

Stuttgart start-up Variolytics: analysis platform accelerates drug development


Variolytics Team

The management team of the Variolytics GmbH (from the left): Stephan Scherle, Head of Technology, Dr. Matthias Stier, Chief Executive Officer, Johann Barlach, Head of Business Operations, Steffen Görner, Head of Production.

Source: Janine Kyofsky

Nonetheless, Variolytics is a long way from taking it easy when it comes to sewage treatment plants. Based on identical hardware used with varying software, the company
is planning nothing less than to offer a key technology for bioreactors as soon as possible. In particular, this can benefit pharmaceutical companies that cultivate cells
or microorganisms in bioreactors to produce active ingredients. To manufacture drugs or vaccines that are effective against COVID-19, for instance, mammalian cell cultures are cultivated in fermenters that require constantly ideal conditions. Unlike sewage treatment plants, many different process parameters need to be continuously monitored in bioreactors used to develop pharmaceutical active ingredients under conditions in the relevant guidelines for Good Manufacturing Practice (GMP). This means, for example, that none of the required sensors must be allowed to present a contamination risk. For the manufacture of, for instance, drugs with antibodies, modern precision medicine now needs smaller reactors, often with single-use systems. This makes the use of individual sensors uneconomical in some cases. Variolytics calculates that it is for this reason that 40 per cent of the necessary key parameters are not captured at all, thus creating yield losses of up to 50 per cent. “In such cases, it isn’t possible to apply consistent control strategies for countermeasures,” explains Stier. “Inadequate sensor data means bioreactors are ultimately operated with low cell densities and high death rates. We replace five sensors and provide six new process parameters, while companies receive more data and save money.” After all, the aim is not just to speed up costly antibody production but make it more cost-effective, too, so that newly developed drugs – such as those given to former U.S. president Donald Trump during his coronavirus infection – do not remain a luxury for the few, but are instead affordable for all patients in the public health system.

Variolytics has developed the analytical equipment in a handy format for use in bioreactors. The heart of the cube-like box, which measures around half a metre along its
edges, is the intake for the analyser unit, which – in a first for mass spectrometry – can also be used to analyse components from the liquid phase. Attached to this intake
is a microporous membrane, via which – drawn by a vacuum – volatile substances from the liquid sample evaporate and pass through the membrane. Besides the innovative hardware of the analytical device, Variolytics has also designed the combination of sensors as a complete platform technology modelled on the smartphone.
“There are various sensors, but it takes the apps to determine the functions,” Stier says. “We combine life sciences with data science, as the huge volumes of sensor
data we are generating can’t be put to use without the right data modelling using artificial intelligence. The aim is smart manufacturing for biotechnology!”

The current pandemic has graphically shown how important it is to speed up drug development and production. Dr. Klaus Eichenberg, Managing Director of BioRegio
STERN Management GmbH, emphatically welcomes this successful new start-up: “Until now, the assumption in the biotech sector has been that it takes a significant
number of years to develop new medicines or vaccines. Vaccine development times have now shortened dramatically. If a platform system such as Variolytics is reliably
monitoring all the parameters, this can also further accelerate the approval of drugs.”

Dr. Matthias Stier Variolytics

Dr. Matthias Stier, CEO of Variolytics GmbH.

Source: Janine Kyofsky
BioRegio STERN Management GmbH