Expanding the frontiers of cell and gene therapy
Founded in Germany in 1989, Milteny Biotec's focus is to support the translational step from basic research to innovative clinical-stage cell and gene therapies. The company has over 2,000 employees based in labs and offices worldwide, and its more than 14,000 products are available in around 100 different countries.
Miltenyi Biotec is based around the company's magnetic-activated cell sorting method, MACS. The company patented the MACS technology in 1990, almost thirty years ago, and with this laid the foundation for its success in cell and gene therapy. The MACS cell sorting method allows researchers to create pools of viable cells with high purity and yield.
Since then, using the MACS technology as its foundation, the company has grown to encompass sample preparation, cell separation, flow cytometry, cell culture and stimulation, cell therapy, cell manufacturing and therapeutic apheresis.
"We see ourselves as a translational company, supporting researchers in the step from the bench to the bedside," said Thomas Kjaer Mogensen, Country Manager Nordics, Milteny Biotec. "We want to help to bring scientific discovery into advancements in medical care."
Miltenyi Biotec's headquarters is in Cologne in Germany, but it is important to the company’s principles to provide local counsel and support through its subsidiaries in the Nordic and Baltic countries, with application scientists in every country.
Flow cytometry as a basis for cell analysis
Following the invention of MACS, Miltenyi Biotec soon added flow cytometry and cell sorting to its product portfolio. The company's MACSQuant flow cytometers support cell analysis, toxicological assays, and proliferation studies on a variety of sample types, including whole blood, cell lines, exosomes, and yeast cells. They are fully automated, from sample labelling and uptake, to data acquisition, and analysis. With an integrated MACS column cells can be enriched before analysis. The instruments come with an intuitive flow cytometry analysis software.
The MACSQuant Tyto next-generation cell sorter uses a microchip-based technology, where the cells are sorted within a single-use, fully-enclosed, and sterile cartridge system. This does not use droplet sorting, unlike earlier technologies, and so there is no tubing, high sorting pressure or charge. Instead, a low air pressure moves the cells through the microchip and into a positive or negative sorting chamber. The system saves in setup time and costs, and samples can be sorted a number of times.
"This is a truly disruptive technology in a positive way, and its gentleness, sterility, safety, and simplicity has already generated a lot of customer interest," said Mogensen.
Focus on cell and gene therapy
Besides cell separation and cell analysis, Miltenyi Biotec has always aimed for direct support of cancer research and the development of cancer treatments. In recent years immunotherapy has been a fast-growing part of cancer therapy – so much so that it's now referred to as the 'fifth pillar' among cancer treatments besides surgery, radiotherapy, chemotherapy, and other targeted therapies. In the field of cell and gene therapy Miltenyi Biotec offers a wide portfolio from reagents, through devices, to services. The company’s CliniMACS CD34 reagent system is a Food and Drug Administration-approved method for selecting stem cells from donors, whilst reducing the numbers of T cells that can trigger graft-versus-host disease.
The CliniMACS system also plays an important role in the emerging field of CAR (chimeric antigen receptor) T cell therapies. To date, two CAR T cell therapies have made it onto the market, and a range of others are in development. With the CliniMACS Prodigy instrument Miltenyi Biotec offers a fully automated device for the CAR T cell production. It can be used in a point-of-care setting like in medical clinics, but also in a decentralized cell manufacturing hub where many patient samples are processed in parallel.
"The combination of the CliniMACS system and our MACS GMP product line allows GMP-compliant manufacture of cell and gene therapies," said Mogensen.
From cell separation to innovation
"We started as a cell separation company, but we now have technologies to carry out all the different steps from basic research to innovative clinical-stage cell therapies. This is what makes us different," says Mogensen. "Translation is a key part of innovation. Many people say that they are innovative, but I really believe that it is true of Miltenyi Biotec – we truly are pushing the boundaries."