|transkript [Kääb, Georg]. (10/21/24). "Miltenyi Biotec: An Exclusive, Rare Interview with Founder Stefan Miltenyi. Interview by |transkript.de/Georg Kääb".

	Organisation	Biocom Interrelations GmbH
	Group	Biocom (Group)
	Organisation 2	Miltenyi Biotec B.V. & Co. KG
	Group	Miltenyi Biotec (Group)
	Product	CliniMACS Prodigy® platform
	Product 2	cell and gene therapy manufacturing (CGT manufacturing)
	Person	Kääb, Georg (Biocom AG 202109– Managing Editor of \|transkript before GoingPublic + BioM)
	Person 2	Miltenyi, Stefan (Miltenyi Biotec 201404 Founder + President)

With regard to biotechnology in Germany, various company names quickly come to mind, such as listed companies or those having raised large financing rounds. Since COVID, everyone knows the largest German biotech company, BioNTech SE in Mainz. If you take a long-time look at the industry, Qiagen and perhaps Evotec are named. But few people know that the largest private company in the sector is based in Bergisch Gladbach near Cologne.

Many have heard the name in the lab or used one of the company’s instruments: Miltenyi Biotec. The company, which is fully owned by the holding Miltenyi Biotec B.V. & Co. KG, and has various subsidiaries, does not engage in much communication work beyond product marketing. Founder Stefan Miltenyi himself keeps a very low profile in terms of communication and is very focussed in his public relations work. That’s why it’s very special and notable that he answered a number of questions from the |transkript editorial team.

|transkript: Mr Miltenyi, you keep a very low profile in terms of communication. People rarely get a deeper insight into your company, so the first question is: how is Miltenyi Biotec doing at the moment? Let’s start with the employees.

Stefan Miltenyi: We employ around 5,000 people worldwide, more than half of them in Germany. Over the past five years, we have grown strongly at all locations in terms of employee numbers and building infrastructure, with disproportionate growth in the USA.

|transkript: Where does Miltenyi have branches?

Stefan Miltenyi: We have six locations in Germany and seven in the USA. We are represented in 24 countries worldwide and also have our own Indian branch since 2024.

|transkript: What about your internationalisation strategy. Where are you focussing your efforts?

Stefan Miltenyi: The USA, together with the APAC region, continues to be faster in the development of new cell and gene therapies [than Europe]. The financial support for biomedical research in the USA in particular is exemplary. China shows how strategic funding can bring cell and gene therapies to patients quickly. India represents a large and growing market with a strong commitment to invest strategically in this area.

|transkript: Nevertheless, there is also a kind of backward movement in the cell and gene therapy sector. Investment, i.e., the financing of companies in this segment, has fallen sharply in recent months, particularly in the USA. Isn’t this worrying for you?

Stefan Miltenyi: In fact, we are seeing a shift in investment activity in the cell and gene therapy market away from smaller start-ups towards larger established players – also because many projects are now in late clinical development phases or even already on the market. As our technological platforms enable a reduction in manufacturing costs, we will be able to benefit from this.

|transkript: What kind of laboratory equipment exactly do you supply to the cell therapy sector?

Stefan Miltenyi: Miltenyi Biotec supplies both the technological platforms and the biologicals that are needed to produce CAR-T cell therapies and to carry out the necessary quality controls. We offer automated manufacturing platforms as well as GMP cell separation reagents, media, cytokines and lentiviral vectors. All of these products have been developed by us and we also make them and our expertise available to co-operation partners in academic research and industry.

|transkript: You are very reticent about providing key financial figures for the company and don’t have to announce anything. However, a few years ago it was said that you were aiming for one billion Euros in turnover. Have you achieved this?

Stefan Miltenyi: Not quite yet, but we are working on it.

|transkript: At Miltenyi Biomedicine, you are developing clinical cell therapeutics yourself, two CAR-T projects are in phase II. DLBCL is an indication in which CAR-T therapies are already available, none of which have achieved a complete breakthrough. What can Miltenyi do ‘better’ in this area than others?

Stefan Miltenyi: The CAR-T cell product from Miltenyi Biomedicine is a tandem CAR against the B-cell antigens CD20 and CD19, so that the tumour escape mechanisms can be better addressed. In addition, the finished cell product is administered ‘fresh’ to patients so that the CAR T cells are not impaired in their efficacy by the freezing process.

|transkript: What’s the state of the clinical development at the moment?

Stefan Miltenyi: The clinical data from the ongoing clinical development so far indicate that Zamto-cel has the potential to be a highly effective and tolerable cell product. Together with our co-operation partners in Erlangen and Tübingen, we have achieved a medical breakthrough with CAR-T cells in autoimmune diseases. Miltenyi Biomedicine is also looking at other promising indications for development projects.

|transkript: In general, we hear that many cell therapies are in clinical studies and that, in addition, the many possible combinations of pre-treatments of patients are slowly becoming over-complex, so that it has become difficult to recruit enough participants for studies. Is this also a problem for Miltenyi?

Stefan Miltenyi: Recruitment for our authorisation studies in Europe and the USA has been completed. In other indications that we are working on, the medical need is high, so we do not expect any problems with the recruitment of the studies.

|transkript: And you manage the financing of such clinical development phases with the benevolent house bank?

Stefan Miltenyi: We finance the studies from our current business.

|transkript: Let’s take the regional establishment of cell therapy treatment and competence centres as a given. Then there are strategic options (in addition to certainly others) to establish additional centres independently, or to supply the equipment for this infrastructure. What is Miltenyi’s strategy?

Stefan Miltenyi: We have now opened our own cell factories in Germany and the USA. Cell separation is today only one part of the complex manufacturing process. We can now provide the entire infrastructure as well as the workflows for the production of a cell therapeutic. This applies not only to CAR-T cells, but also to genetically modified haematopoietic stem cells and many other cell types.

|transkript: Additional services can also be developed around the ‘cell product’: Quality control of the cell material, closed GMP equipment, needle-to-needle automation, data analysis, etc. Where does Miltenyi see itself?

Stefan Miltenyi: We have developed solutions for all of these areas. The CliniMACS Prodigy is now the industry standard as a closed, fully automated system for cell production. For quality control in the manufacturing process, we offer a comprehensive solution with our MACS Quant Flow Cytometers and our antibody panels. With our MACSima imaging platform, we offer researchers new ways of analysing complex cellular interactions, including in tumours, using protein profiling and RNA detection (keyword: spatial biology). In addition, there are the many (GMP) reagents, software solutions, and our customised CDMO services from Miltenyi Bioindustry with our own CliniMACS Cell Factories in Germany and the USA, as well as GMP infrastructure for the production of lentiviral vectors and other biologicals. We have many ongoing projects to make new cell and gene therapies available to more patients in the future.

|transkript: Then you certainly welcome the fact that Germany has now also adopted a ‘National Cell Therapy Strategy’ after some delays and wants to provide more support for the sector?

Stefan Miltenyi: The initiative is also relevant for Miltenyi Biotec and Biomedicine and we are actively involved in it. We produce almost 100% in Germany – a clear commitment to the location. In order to be able to continue to do so in the future, Germany must become more attractive again for cutting-edge research. In addition, legislative and regulatory procedures must keep pace with innovative developments and, for example, pave faster and simpler paths to commercial success, so that companies are staying in Germany for the long term. The USA is way ahead of us here. The national strategy is first and foremost a clear signal to the federal government to provide better and more strategic support for research and development of gene and cell therapies in the future. It will now be crucial to see how quickly the strategy is implemented so that Germany does not de-industrialise in this area as well.

|transkript: Now, with the founding of Miltenyi in 1989, you are, please excuse me, a dinosaur in the industry. Are you already thinking about a successor, about retirement, or is that not a current topic for you?

Stefan Miltenyi: The company now rests on the shoulders of many employees. I am not planning to retire in the near future.

Stefan Miltenyi did not want to answer any further questions, such as more details about the company’s financial resources and substance. He probably doesn’t need to, as Kreissparkasse Köln, the company’s principal bank, regularly extends large loans to the healthy company. In July 2023, one of the few public announcements was made that a new loan from Kreissparkasse Köln to the holding company Miltenyi Biotec B.V. & Co. KG had increased the total financing volume to EUR 375 million. This is probably why Miltenyi is never heard joining in the general lament about the industry’s financial situation.

The interview was conducted by Dr. Georg Kääb, Editor-in-Chief of the trade magazine |transkript, covering the German-speaking biotech landscape.

You can read the original German version at https://transkript.de/hintergrund/2024/miltenyi-seltene-einblicke/

Record changed: 2024-11-25