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Safer, more efficient drug testing

Bionter revolutionizes analytical testing to benefit people’s health.

Bionter founder and CEO
Tobias Werk

Could you explain what your startup does in a few sentences?

We are creating the tools to optimize the development of innovative drugs. With that we will enhance patient safety and improve people's health – this is driving us. Our first product is a particle counter to count sub-visible particles in injectables.

Which innovation does your startup bring to the market?

Many liquid drugs contain particles considered potentially critical for patient safety. Thus, sub-visible particle testing is mandatory for any bio-pharmaceutical preparation and is being used for stability testing, drug formulation and process development, and in-process control testing.

However, the technology fulfilling compendial requirements was originally designed to check hydraulic oil and kerosene used in aerospace and was not tailored to the pharmaceutical need. Up until today, the most used technology comprises many manual steps and destroys the precious drug product sample during testing.

We developed a new particle counter, supported by single-use consumables, maintenance, and training services. The EVE-system works non-destructively. Therefore, it requires a smaller sample volume, which can be used for further testing, thus reducing costs. Its smart automation workflow drives efficiency and minimizes human interaction, and therefore improves reliability, data integrity and, in turn, patient safety. Of course, it is also compliant with current regulatory requirements.

What plans do you have for your startup in the next several months?

This is a very exciting stage of our venture. In Sales and Marketing, we are focusing on the market launch of our particle counter in the USA, currently our largest market. This will be accompanied by recruitment and the build-up of our office and laboratory space.

At the same time, we are working on expanding our product portfolio. We have a balanced research product portfolio, including smaller internal conceptual studies and larger innovation projects in collaboration with research partners such as CSEM.

In addition, we are collecting even more scientific data on applications for our particle counter in collaboration with a local CDMO to demonstrate its perfect fit in Pharma Development. In 2023, we aim to reach our BEP.

It is also important to me, to build my company in such a way that people love working there and feel empowered to fulfill their purpose and work in a people-oriented environment. At the same time, I want to build a sustainable company that recognizes its responsibility as a corporate citizen in society and the environment.

What was the deciding factor to launch your business?

When I started in the pharmaceutical industry more than a decade ago, I realized that many testing applications were not tailored to their true needs. I realized fairly quickly that my strength was technical innovation, and that I wanted to contribute to a healthier world. But the deciding factor to found Bionter was triggered by reading the book “The Big Five For Life”. After I wrote down my purpose and defined my 5 goals in life, starting a company became inevitable. With many ideas in mind for improving analytical testing of bio-pharmaceutical products, I founded Bionter. My goal is to transform those ideas into products, which perfectly meet customers’ needs, and, in turn, allow our customers to ensure drug products of the highest quality.


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