Miltenyi Biotec
 | |
| Private | |
| Industry | Biotechnology |
| Founded | 1989 |
| Founder | Stefan Miltenyi |
| Headquarters | Bergisch Gladbach, Germany |
Key people |
Stefan Miltenyi, Founder & President |
| Products |
MACS Sample Preparation |
Number of employees | Approx. 1,400 |
| Website | www.miltenyibiotec.com |
Miltenyi Biotec is a global biotechnology company headquartered near Cologne in Bergisch Gladbach, Germany. The company is a provider of products and services that support scientists, clinical researchers, and physicians across basic research, translational research, and clinical applications. The company offers solutions covering techniques of sample preparation, cell separation, cell sorting, flow cytometry, cell culture, molecular analysis, clinical applications and small animal imaging. These technologies support a complete workflow, enabling the access, analysis and utilization of primary and primary-derived cells. Since its founding in 1989, the company has been dedicated to the promise of cellular therapy and the goal of making cellular therapy a greater reality for more patients. Miltenyi Biotec has more than 1,400 employees in 25 countries and a portfolio of more than 3,000 products.
Products
Miltenyi Biotec products have been cited in more than 20,000 publications and used in more than 35.000 clinical treatments to date. Many of the publications that have cited Miltenyi Biotec products can be accessed through CiteAb, an antibody search engine which lists 4591 Miltenyi Biotec products.[1] Miltenyi Biotec instruments, reagents and services support basic research, clinical research, and the translation of basic research findings into clinical applications that enhance human health and treat severe disease. Its product portfolio addresses a complete range of techniques from bench to bedside. Services offered by Miltenyi Biotec include gene expression analysis[2] and contract production of biologicals according to GMP guidelines.
Miltenyi Biotec technologies are used in applications concerned with accessing, analyzing, and utilizing primary and primary-derived cells – across basic research, translational research, and clinical applications.[3] Examples of these applications include sample preparation, cell separation, cell sorting, flow cytometry, molecular applications, cell culture up to GMP grade, preclinical imaging, clinical-grade cell preservation, and clinical-scale cell processing. The company’s reagents and devices are used primarily in the research areas of immunology, stem cell biology, neuroscience and cancer.[4]
Sample Preparation
Miltenyi Biotec offers instruments, tools and reagents to facilitate standardized and effective sample preparation. The gentleMACS Dissociators and reagents used together with MACS Tissue Dissociation Kits offer researchers high cell viability and excellent single-cell suspensions after tissue dissociation.
Cell Separation
Cell separation technology based on super paramagnetic beads was invented by the company founder, Stefan Miltenyi, in 1989 and enables the separation of any cell type using antibodies bound to magnetic beads. The company has since developed a wide variety of reagents and devices optimized for manual and automated cell separation procedures, the lab bench, and clinical research. With a market share of 70%, Miltenyi Biotec is the leader in the field of magnetic cell separation.
MACS Technology is used to isolate cells from blood, bone marrow or dissociated tissue according to specific surface markers. Cells that have been studied in this way include T lymphocytes, B lymphocytes, NK cells, dendritic cells, stem cells, tumor cells and neural cells. Isolated, adult progenitor / stem cell populations that express CD34 or CD133 markers on their surface have been used for cellular therapy in clinical settings.
Cell Sorting
Miltenyi Biotec has expanded its portfolio to include a novel microchip-based cell sorting technology with the acquisition of Santa Barbara-based Owl biuomedical, Inc. in April 2013. (cite) The microchip-based cell sorting technology uses a closed, disposable, fluid path cartridge that enables plug and play cell sorting. The cartridge technology utilizes a patented silicon microchip capable of extraordinarily high-frequency fluidic valving. This cell sorting technology is a major advancement in the field, allowing researchers to process small to large-scale samples in a gentle, efficient manner – all in a sterile environment that keeps users safe from potentially harmful samples and protects cells from contamination.
Flow Cytometry
Miltenyi Biotec’s MACSQuant family of flow cytometry instruments combines pre-enrichment of rare target cells with precision flow cytometric analysis in a compact bench-top from. The MACSQuant VYB utilizes the powerful yellow laser to enable four-laser functionality in a three-laser layout. The MACSQuant instruments were the first to make complex flow cytometry technology affordable and easy to use for researchers at every level. The portfolio includes MACS Antibodies, a large offering of cell surface marker-specific fluorochrome-conjugated antibodies, and a range of unique reagents for analysis of dendritic cells, stem cells, and cytokine-secreting cells. Miltenyi Biotec’s flow cytometry products are used across many distinguished research centers around the world, including Caltech and the Pasteur Institute.
Molecular Applications
The company’s magnetic bead technology can also be used to separate organelles, such as mitochondria, as well as mRNA molecules, which, after converting to cDNAs, can be applied to microarrays for gene expression analysis. The MACSmolecular product portfolio provides innovative kits and regagents for the sensitive isolation and analysis of mRNA, microRNA, DNA, protein, viruses, and organelles.
Imaging Agents for preclinical imaging
Miltenyi Biotec’s Viscover Imaging Agents portfolio consists of a range of contrast agents for small animal studies in vivo and includes FeraTrack™ which enables MRI-tracking of labeled cells in real time. This portfolio of small animal in vivo imaging agents is the first to cover all of the principle imaging modalities, including MRI, CT, optical imaging and ultrasound.
Cell Culture
The MACS Cell Culture product line brings together a specialized and versatile range of cell culture media and reagents for the stimulation, expansion, and differentiation of human and mouse primary cells, including immune cells, stem cells, and neural cells. Small molecules and reprogramming reagents are offered for stem cell research, and chemically defined specialty media are offered for the production of recombinant proteins in eukaryotic cell lines. Selected antigens, cytokines, and media are produced according to GMP guidelines and under conditions free of animal-derived components, which helps enables transition into clinical research.
Cytokines
Miltenyi Biotec offers an extensive portfolio of recombinant cytokines and growth factors. MACS Cytokines are designed for demanding applications such as cell culture, differentiation studies, and functional assays mainly in the fields of immunology, neurology, and stem cell research. With optimized GMP-compliant manufacturing processes, MACS Cytokines offer researchers consistent batch-to-batch quality and performance. MACS Cytokines are used for basic, pre-clinical, and clinical research.
Clinical Products
Miltenyi Biotec provides comprehensive systems for clinical researchers in various therapeutic areas. The CliniMACS System is based on MACS Technology and includes the CliniMACS Prodigy, an integrated cell processing device that complies with all current technical requirements for manufacturing cellular products. It fully automates the process of preparing cell products for clinical applications, from separating the desired cells, to their expansion and differentiation in an integrated culture chamber. Therefore, cell preparation procedures can be standardized and innovative cellular therapies are enabled on a routine basis. The CliniMACS Plus instrument enables sophisticated applications for a variety of separations. The selected stem cells, monocytes, DCs, NK cells, B cells and T cell subsets allow research in the fields of regenerative medicine, adoptive immunotherapy and graft engineering. Since 1997, more than 35,000 clinical treatments on the basis of MACS Technology have been performed.
CryoMACS Freezing Bags have raised the level of safety in cryopreservation of hematopoietic cells with their additional overwrap bags and other unique design features. MACS GMP Products offer antibodies, antigens, cytokines, cell culture bags, and cell culture media that comply with GMP specifications to ensure high safety and quality levels.
TheraSorb Therapeutic Apheresis
The company’s therapeutic apheresis products are used in clinical applications and its instruments are used in clinical-scale cell separation and processing. The TheraSorb™ Therapeutic Apheresis system is based on the selective removal of pathogenic substances from the patient’s plasma. During apheresis, target molecules are selectively removed while the plasma is reinfused into the patient. Hence, higher plasma volumes can be processed than in therapeutic plasma exchange. Since no substitution fluid is required, the treatment is usually very well tolerated. TheraSorb Products may be helpful for the treatment of diseases associated with hypercholesterolemia, pathogenic immunoglobulins, and fibrinogen.
Application areas
Miltenyi Biotec products are used commonly in the application areas of immunology, stem cell biology, neuroscience and cancer. Their products are used from basic research to clinical applications and are designed to support the successful translation of findings into practical applications that enhance human health and well being. Enabling translational research is a major mission of the company, as is advancing cellular therapy. The company’s products aim to support the development of cellular therapies and make cellular therapy a more viable reality for more patients.
Immunology
The company’s immunology products have been cited in many major publications by leading immunologists, including 2011 Nobel Prize in Physiology or Medicine winner Ralph M. Steinman. The company provides a comprehensive portfolio for immunology research, including autoimmunity, tumor immunology, dermatology, allergy, infection and inflammation research, and more. MACS Technology allows for the isolation of any immune cell type – from pan T cells to rare subsets, such as regulatory B cells. Detailed analysis is achieved using their broad flow cytometry portfolio, including numerous unique fluorochrome-conjugated antibodies and kits. A variety of reagents for effective cell stimulation and culture enable analysis of cell function.
Stem cell research
In the field of stem cells, Miltenyi Biotec products have been cited in many prominent publications by leading stem cell researchers, including 2012 Nobel Prize for Physiology or Medicine winner Dr. Shinya Yamanaka. The company offers an extensive portfolio for stem cell researchers – from stem cell isolation, through optimized culture conditions using media, cytokines, and small molecules, to sophisticated cellular and molecular analyses. They offer innovative solutions for research on hematopoietic stem or progenitor cells, mesenchymal stem cells, cancer stem cells, and embryonic and induced pluripotent stem cells facilitate cellular reprogramming, maintenance, and differentiation. The company continues to provide novel tools for stem cell research, with the vision to advance clinical translation in additional stem cell fields such as MSCs, ES and iPS cells.
Cancer research
Miltenyi Biotec’s tumor dissociation products play a significant role in the field of cancer research. The combination of tissue dissociation instrumentation (gentleMACS Dissociator) and tumor dissociation kits for almost all types of tumors offers cancer researchers a standardized, user-independent platform to obtain viable single-cell suspensions from solid tumors or metastasis, without harming cell surface epitopes or cell adhesion molecules. The company offers cancer research solutions for the gentle dissociation of tumors, the isolation of circulating or hematological tumor cells, cancer stem cells, endothelial cells, or tumor immune cells, as well as sophisticated flow cytometry and reliable cell culture.
Neuroscience
In the field of neuroscience, Miltenyi Biotec’s combination of tissue dissociation instrumentation and kits has made an important impact, particularly in areas like brain tissue dissociation with myelin removal. Also, the use of their cell isolation technology on neural cells enables pure cultures in shorter time, hours or days instead of weeks. Their products cover the complete neuroscience workflow. Sophisticated instruments and reagents enable effective dissociation of brain tissue. MACS Technology allows for fast, efficient myelin removal and gentle isolation of neural cells, including neural stem or progenitor cells, glial progenitors, neurons, astrocytes, microglia, and ogliodendrocytes. For subsequent analysis by flow cytometry or fluorescence microscopy, a wide range of antibodies are offered. Specialized media and supplements maintain functionality and a healthy morphology of neural cell types during culture. Small animal imaging agents allow for the clear in vivo visualization of internal structures, for example brain and spinal cord.
Translational research
One of the keys for the successful translation of scientific discovery into clinical application is high-quality data from the start. Miltenyi Biotec has developed a spectrum of products for all aspects of translational research that allows researchers to go from bench to bedside without unnecessary, time-consuming, or expensive duplication of experiments. For example, a research project can start with their research-grade products and move seamlessly from premium to GMP grade – which is the most adequate grade for the development of a cellular therapy to be tested in clinical research. With research- to GMP-grade cytokines or antigens, media of different grades, GMP-grade cell culture bags or freezing bags, Miltenyi Biotec products make the translation of basic research findings into practical applications for human health more easily achievable.
Clinical setting
Miltenyi Biotec’s product portfolio spans many critical aspects of developing a cellular therapy and many products are available in clinical grade. Thus, many steps can then be translated into clinical research protocols using the company’s MACS GMP and CliniMACS Products. The company provides comprehensive systems for clinical researchers in a multitude of therapeutic areas. In combination with their high-quality MACS GMP and CryoMACS products, the automated CliniMACS Separation System enables consistent generation of cellular products for a range of clinical applications. Furthermore, the company’s clinical development team coordinates a worldwide clinical trial program in close cooperation with leading investigators to test the therapeutic utility of their clinical products. Areas of activity include all aspects of their product portfolio with an emphasis on hemato-oncological, infectious, cardiovascular, immunological and other indications.
History
- 1989 – Stefan Miltenyi invents magnetic-activated cell separation
- 1990 – Miltenyi Biotec patents MACS Technology
- 1992 – Miltenyi Biotec opens its U.S. subsidiary
- 1995 – Miltenyi Biotec opens its U.K. subsidiary
- 1998 – Miltenyi Biotec opens its France, Italy and Spain subsidiaries
- 2001 – Miltenyi Biotec opens its China location
- 2002 – Miltenyi Biotec acquires the plasma absorber technology developed by PlasmaSelect AG and markets the products under the trademark TheraSorb
- 2002 – Miltenyi Biotec opens its Australia subsidiary
- 2003 – Miltenyi Biotec opens its GMP facility in Teterow, Germany
- 2003 – Miltenyi Biotec opens its Japan and Singapore subsidiaries
- 2003 – Miltenyi Biotec acquires Memorec Biotec GmbH
- 2004 – Miltenyi Biotec opens its Benelux subsidiary in The Netherlands
- 2008 – Miltenyi Biotec acquires Medic Tools AG [5]
- 2008 – Miltenyi Biotec launches its autoMACS Pro Separator cell separation instrument
- 2008 – Miltenyi Biotec launches its MACSQuant Analyzer flow cytometry instrument
- 2011 – Miltenyi Biotec acquires Coley Pharmaceutical Group
- 2011 – Miltenyi Biotec partners with TeutoCell to develop novel cell culture techniques [6]
- 2012 – Miltenyi Biotec opens its Nordic subsidiary in Sweden
- 2012 – Miltenyi Biotec opens its Korea subsidiary in Seoul, South Korea
- 2013 – Miltenyi Biotec acquires Owl biomedical, adding to their portfolio new microchip-based cell sorting technology
- 2014 – Miltenyi Biotec receives FDA approval for CliniMACS® CD34 Reagent System for prevention of graft-versus-host disease in the treatment of acute myeloid leukemia
- 2014 – Miltenyi Biotec acquires gene therapy assets from Lentigen Corporation
Structure
Miltenyi Biotec is a limited liability company (referred to as GmbH in Germany). The officers of the company are Stefan Miltenyi (Founder and President), Dr. Boris Stoffel (CEO), and Norbert Hentschel (Chief Financial Officer). Headquartered in Bergisch Gladbach with a GMP facility in Teterow, Germany, Miltenyi Biotec also has locations in the United States, Great Britain, France, Italy, Spain, China, Australia, Japan, The Netherlands, Singapore and Sweden. The company has more than 1,300 employees worldwide.