Undercover biotech star expands into cell therapy

Frankfurt Novel cell and gene therapies have been causing a sensation in medicine for several years. German pharmaceutical companies do not yet play a major role here. But a biotech company that is hardly known to the public is one of the pioneers of the new process. Miltenyi Biotec has not only grown into a global technology supplier, but is also involved in the development of cell therapies with several of its own clinical projects.

Unlike Mainz-based Biontech, Miltenyi is more of a secret star of the German biotech scene. At the same time, the pace of expansion is remarkable, even in an international comparison. Last year, the company from Bergisch Gladbach near Cologne increased its turnover by a quarter to 880 million euros. Since 2012, sales have increased more than sixfold. The upswing is likely to continue in the coming years.

“In 2023 we are aiming for a turnover of more than one billion euros,” says company founder and owner Stefan Miltenyi to the Handelsblatt. The company, which was founded in 1989, is currently number three in the German biotech industry after Biontech and Qiagen. Miltenyi employs 4,500 people in 28 countries worldwide, 900 of them in the USA alone. Around 93 percent of the proceeds come from abroad, and the trend is rising.

Miltenyi pioneered cell separation

Company founder Miltenyi laid the basis for success with his pioneering work in the field of cell separation. The MACS (Magnetic Activated Cell Sorting) technology he developed while he was still studying physics in Cologne makes it possible to isolate individual cell types from a mixture by coupling small magnetic particles to specific cell receptors with the help of antibodies. The cells marked in this way can be separated from the rest of the mixture in a strong magnetic field.

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To this day, Miltenyi sees itself as the world market leader in this area. The technology is used across the board in biopharmaceutical research and, to some extent, also in medical practice, for example in blood purification procedures, stem cell transplantations or for the production of the new Car-T cell therapies, in which genetically modified immune cells are used to fight cancer.

>> Read also: Fighting cancer with killer cells: Researchers are advancing revolutionary therapy

The company has now developed a wide range of devices and reagents for biomedical research, including thousands of individual products, based on MACS technology, including other methods for cell sorting. Miltenyi also entered the field of microscopy through acquisitions and in-house developments.

The company is now also involved in the development of new gene sequencing techniques. “We are driven by the vision of making serious diseases curable with our technologies and making cell therapies accessible to many patients worldwide,” says Miltenyi, describing the strategic orientation.

In view of the boom in cell research, there is hardly any end in sight for the company for the time being. The first cell therapies, for example against cancer, have now been approved, and the number of research projects in this area has been growing rapidly for years.

In addition to cancer treatment, intensive work is now also being done on regenerative cell therapies, for example against cardiovascular diseases or Parkinson’s disease. Market researchers therefore assume that the market volume for cell separation technologies will triple to more than 25 billion dollars by 2028.

Miltenyi relies on “multidisciplinary innovative strength”

In this environment, Miltenyi competes with large corporations such as Thermo Fisher, Becton Dickinson and the German Merck Group, among others. The founder sees a significant strength of his company in the great technological breadth and the close cooperation of biotechnologists, physicists, chemists, physicians, pharmacists and engineers.

Miltenyi, who studied medicine as well as physics, speaks of a “multidisciplinary innovative strength”. Genetic engineering methods are used, as are plastics technology, microstructure technology, optics and instrument design. “We can build complex medical devices as well as design novel biomolecules or gene vectors and manufacture them pharmaceutically.”

From his point of view, starting his own cell therapy research in 2019 was a logical step. “We had developed all the components to make such therapies possible and we are sitting at the source to develop new therapies by bringing different scientific disciplines together,” says Miltenyi.

The subsidiary Miltenyi Biomedicines is now testing several cell therapies in clinical studies in the USA and Europe. The first approval-relevant data for the most advanced project are expected by the end of next year.

We can build complex medical devices as well as design novel biomolecules or gene vectors and produce them pharmaceutically. Stefan Miltenyi, founder of Miltenyi Biotec

A number of other products are in the early stages of clinical development, including a therapy for the serious immune disease lupus erythematosus. Here, too, the first patients have already been treated successfully.

The competition from pharmaceutical giants such as Gilead, Novartis, Bristol-Myers Squibb and Bayer, which are also investing heavily in cell therapies, does not deter Stefan Miltenyi. He points to the company’s strong network within the scientific community and the great expertise in the development of cell therapies, which it has long shared with customers. “We are convinced that our approaches can offer further improvements in the treatment of cancer,” he says.

The upstart from the Rhineland is thus one of the very few biotech suppliers who are also involved in clinical research themselves. It has not yet been decided whether, in the event of success, the products will actually be marketed on their own or in cooperation with partners from the pharmaceutical industry.

Starting capital: 5000 marks and a thesis

The company’s career is also unusual in another respect: Unlike most biotech start-ups, Miltenyi was never dependent on venture capital from external investors, even in the early stages. “5000 Deutschmarks and the development from my diploma thesis were enough,” he says. “We have always made a profit and invested it again.”

The company has so far been able to finance the strong expansion and expansion of the production facilities entirely from its own cash flow and through bank loans. For 2021, the company reported sales of EUR 699 million, a net profit of EUR 68 million and an operating cash flow of EUR 114 million.

Company founder Miltenyi is still 100 percent owner. Taking on external financiers, for example through a listing on the capital market, is not an issue for him. “An IPO is not planned and is not part of the future considerations,” he says. “It is part of the company’s success and a great freedom to advance our vision together with and for our customers without considering investor interests.”

More: German biotech companies raise significantly less capital.

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