COMPANY PROFILE / CELL CULTURE TECHNOLOGY
Miltenyi Biotec
A maker of equipment to "separate, grow and manufacture" cells that has spread into contract manufacturing and its own CAR-T
Miltenyi Biotec is a privately held biotechnology company founded in Germany in 1989. It started out with MACS, a technology for selecting cells with magnetic beads, and today it has CliniMACS Prodigy, an instrument that manufactures cell therapies automatically in hospitals and plants, reagents such as media and cytokines, and even a contract development and manufacturing (CDMO) division. The company's website says that eight commercially approved cell therapies are built on CliniMACS Prodigy Sourced. Given that the company is private and publishes no financials, this profile sets out its resources, partnerships and direction in cell culture using only what can be confirmed from its official website and official press releases.
- Miltenyi Biotec in 30 seconds, and where it stands in cell culture
- The logo and how the name is written
- Where the company sits in the cell culture field
- Scale (financials not disclosed)
- Resources committed to cell culture
- What it has done so far
- What comes next
- What the company is aiming for in cell culture
- Map of cell culture partnerships
- Technologies, products and services
- The risks this company carries
- Glossary, references and claim-to-source audit
1. Miltenyi Biotec in 30 seconds, and where it stands in cell culture
B.V. & Co. KGCommercial register of the Cologne local court, HRA 34194
GermanyFriedrich-Ebert-Straße 68
Secondary: CDMOA group company is also developing its own CAR-T in the clinic
and gene therapyNo mention found of antibody production (CHO cells)
Germany and ChinaAs published by the Miltenyi Bioindustry division
Companies involved in cell culture fall into three broad types: contract development and manufacturing organisations (CDMOs), suppliers of tools, consumables and media, and developers of cell and regenerative therapies. Miltenyi Biotec's main type is supplier: it sells reagents for separating cells, media and cytokines, and instruments that manufacture cell therapies automatically. On top of that, a division called Miltenyi Bioindustry manufactures lentiviral vectors and cell products under contract as a CDMO Sourced, and a group company, Miltenyi Biomedicine, is developing its own CAR-T candidates in clinical trials Sourced. In other words, a company that "sells the tools" has reached into both contract manufacturing with those tools and developing its own products with those tools. Its involvement is mainly in culture for cell and gene therapy, where the cells themselves are the product; a business in large-scale culture of CHO cells and the like for antibody drugs does not appear in the primary sources we checked.
2. The logo and how the name is written
The Miltenyi Biotec logo is a trademark of the company. We have not recreated it with generated imagery;
the file img/miltenyi_biotec_logo.svg is a logo image served on the company's official website.
A note on names: the current legal name is Miltenyi Biotec B.V. & Co. KG (as given in the legal notice, or Impressum, on its website). A 2018 press release gives the name as "Miltenyi Biotec GmbH", so the legal form has varied over time. Contract manufacturing is handled by Miltenyi Bioindustry (an in-house division) and development of its own CAR-T by Miltenyi Biomedicine (a group company founded in 2019); the names are similar but the roles differ. The founder, Stefan Miltenyi, is still listed among the managing directors.
https://www.miltenyibiotec.com/3. Where the company sits in the cell culture field
In a phrase, Miltenyi is a company that sells the "manufacturing process" of cell therapy itself. This is not the world of antibody drugs, where cells are grown in bulk in tanks. CliniMACS Prodigy takes cells from a single patient or a single donor and, automatically and inside one closed instrument, selects them, inserts genes, expands them and formulates them into a product. The company sells this instrument, sells the reagents and disposables used with it, and also takes on contract manufacturing using it Sourced.
4. Scale (financials not disclosed)
Miltenyi Biotec is privately held, and its official website and press releases give no revenue, profit, R&D spending or capital expenditure Not yet confirmed. Germany has a system under which companies publish their financial statements through the commercial register and the electronic Federal Gazette, but this article has not checked those. We therefore show the company's size through the headcount, number of sites and number of products it publishes itself.
| When published | Employees | Countries and regions | Source (company boilerplate in official announcements) |
|---|---|---|---|
| January 2014 | More than 1,300 | 22 countries | Press release on FDA approval of the CliniMACS CD34 Reagent System |
| August 2014 | More than 1,400 | 25 countries | Press release on the acquisition of Lentigen assets |
| September 2024 | More than 4,900 | 24 countries | Press release on vector manufacturing for Adaptimmune |
| July to September 2026 | More than 5,000 | 24 countries | Press releases on S.O.L.A.R.I.S., BioOra and Tr1X |
From more than 1,300 at the start of 2014 to more than 5,000 in 2026, headcount has grown about 3.8 times in around twelve and a half years Our calculation (5,000 ÷ 1,300; both are "more than" figures, so the ratio is only a guide). The company profile page also publishes the following figures Sourced.
| Measure (company profile page) | Published figure | Notes |
|---|---|---|
| Employees | More than 5,000 | From more than 75 countries |
| Share of employees in R&D | 23% | 23% of more than 5,000 is about 1,150 or more Our calculation |
| Locations | 27 | In Europe, headquarters and GMP production site plus subsidiaries in eight regions; seven offices in the U.S.; teams in Asia-Pacific |
| Countries served (including distributors) | 71 | - |
| Number of products | More than 21,000 | The same page also says "more than 18,000"; the figures do not match |
| Patients treated with cell products made on its platforms | More than 120,000 | Cumulative. The method of calculation is not given |
Even within the official website, the number of products (more than 21,000 / more than 18,000), the number of countries employees come from (more than 75 / more than 70) and the track record in cell therapy ("more than 10,000 patients a year", "more than 6,000 patients a year", "more than 150,000 cell therapy procedures" and so on) appear as different figures on different pages and at different times Sourced. This article simply shows which figure appeared on which page, without averaging or adjusting them. Keep in mind too that self-reported figures from a private company are different in nature from audited statutory disclosures.
5. Resources committed to cell culture
Following our standard method, we look at four things (people, money, investments and acquisitions, and links with universities and research institutions) and note whether each could be confirmed from primary sources.
| Aspect | What primary sources confirm | Status |
|---|---|---|
| People (dedicated organisation, sites, headcount) | A CDMO division, Miltenyi Bioindustry, with five published sites: San Jose and Gaithersburg in the U.S., Bergisch Gladbach and Teterow in Germany, and Shanghai in China. R&D staff make up 23% of all employees. The Teterow site had about 500 people in 2021. Headcount dedicated to cell culture is not disclosed | Partly confirmed (headcount not disclosed) |
| Money (capital expenditure and R&D) | Neither R&D spending nor capital expenditure is published. In 2021 the company acquired a former factory site (51,000 m²) in Laage, Germany, and in 2024 it announced plans to invest in a training centre in India, but no amounts are given | Not disclosed |
| Investments and acquisitions | In 2014 it acquired Lentigen's lentiviral vector manufacturing business and related assets (setting up a new U.S. subsidiary, Lentigen Technology, Inc.). It also acquired and integrated Living Pharma's CAR-T technology. The timeline on the company profile lists technology acquisitions such as "adapter CAR T technology" in 2017. No prices are disclosed. No investments in start-ups are mentioned | Acquisitions confirmed / investments not found |
| Universities and research institutions | Coordinator of S.O.L.A.R.I.S. (13 partners), an EU Horizon Europe project. Provides technology and training to seven university hospitals in North Rhine-Westphalia (NRW), Germany. The official website cites "more than 500 collaboration partners", "more than 50 European projects" and "more than 60 national projects" | Confirmed |
In making gene-modified cells such as CAR-T, the lentiviral vector that carries the gene into the cell is one of the raw materials most prone to supply constraints. Miltenyi acquired Lentigen's manufacturing business in 2014 and says it runs a vector manufacturing platform at its Gaithersburg site based on serum-free suspension culture Sourced. An August 2026 announcement says the site has shipped more than 500 GMP batches at 50-litre and 200-litre scale since its approval in 2024 Sourced. Having both kinds of culture in one company, "suspension culture of cells to make vectors" and "culture of patients' cells", is what sets it apart from manufacturers that only sell equipment. The name of the cell line used for vector production does not appear in the material we checked.
6. What it has done so far
| When | What happened | Why it matters |
|---|---|---|
| 1989 | Founded in Germany, starting from MACS magnetic cell separation technology | Begins as a company that "selects cells" |
| 2002 | Opens a GMP manufacturing facility in Teterow, Germany | The basis for in-house manufacture of clinical reagents and products |
| January 2014 | The CliniMACS CD34 Reagent System is approved by the FDA as a Humanitarian Use Device (HDE) | Used to enrich CD34-positive cells in allogeneic transplants for acute myeloid leukaemia, to prevent GVHD |
| August 2014 | Acquires Lentigen's lentiviral vector manufacturing business | Brings the gene transfer raw material in house. The origin of the Gaithersburg site |
| February to March 2018 | The EMA approves use of CliniMACS Prodigy in the commercial manufacture of MolMed's cell therapy Zalmoxis | According to the company, the first time Prodigy entered the manufacturing process of a commercial medicine |
| April 2018 | Long-term supply agreement for CliniMACS Prodigy with Autolus | Leads later to the FDA-approved AUCATZYL |
| 2018 | The CliniMACS Cell Factory in Bergisch Gladbach obtains a manufacturing authorisation | A base for contract manufacturing (later Bioindustry) |
| 2019 | Founds the group company Miltenyi Biomedicine | An organisation to develop its own cell therapies |
| July 2020 | Launches the CliniMACS Prodigy Adherent Cell Culture System | Automates expansion of mesenchymal stromal cells and pluripotent stem cells, and even differentiation into dopaminergic progenitors |
| 2021 | Opens a CliniMACS Cell Factory in San Jose, California; in December, acquires a factory site in Laage, Germany | Expands contract manufacturing and production capacity |
| March 2022 | Joins a cell therapy network of seven university hospitals backed by NRW (€7.75 million of state funding) | Putting manufacturing inside hospitals (point of care) into practice |
| December 2023 | Grants Syena, part of Replay, an exclusive licence to a PRAME-targeting TCR and takes on GMP manufacturing of TCR-NK cells | Offers its own receptor technology and manufacturing as a package |
| February 2024 | Opens its first office in India, in Hyderabad, and plans to invest in a cell and gene therapy training centre | Helping emerging markets set up manufacturing |
| May to September 2024 | The Gaithersburg site passes the FDA's pre-license inspection. Commercial manufacture of vector for Adaptimmune's TECELRA (FDA-approved on 1 August 2024) | Gains a track record as a CDMO supplying a commercial product |
| November 2024 | Announces commercial supply of the full CliniMACS Prodigy platform for manufacture of Autolus's FDA-approved AUCATZYL | A commercial track record as an equipment supplier |
| July 2026 | Launches the EU project S.O.L.A.R.I.S. as coordinator (budget €7,997,648, running to June 2030) | Plans to add seven new modules to Prodigy |
| August to September 2026 | Announces a commercial vector supply agreement with BioOra (New Zealand) and a contract manufacturing collaboration with Tr1X | Widens its CDMO customer base |
7. What comes next
for ProdigyJuly 2026 to June 2030. Tested at six manufacturing hubs
pivotal trialsRelapsed or refractory DLBCL. Miltenyi Biomedicine
clinical developmentSystemic lupus erythematosus and others
on the Laage siteAnnounced in 2021. Timing and scale not disclosed
The plans that can be read from official announcements fall into three strands: more advanced equipment (developing automation and digital modules under S.O.L.A.R.I.S.), support for commercialising customers' products through contract manufacturing (vector supply for pre-approval candidates such as BioOra's Atla-cel), and development of its own products (Miltenyi Biomedicine's zamto-cel and CAR-T for autoimmune disease) Sourced.
None of the following appears on the official website or in official announcements Not yet confirmed.
Revenue and the share from cell therapy; R&D spending and capital expenditure; when production will start on the Laage site and with what capacity; the investment amount and opening date for the training centre in India; when zamto-cel will be filed for approval; and the number of contracts and utilisation of the CDMO division. Press reports and research-firm estimates are not used in this article.
8. What the company is aiming for in cell culture
This section goes beyond what the company says directly. It sets out inferences that can be drawn from primary sources, each with its basis.
| What can be read | Primary evidence behind it | Category |
|---|---|---|
| Its aim is to own the standard manufacturing process for cell therapy within one company | The Tr1X announcement presents an "integrated offering" spanning equipment (Prodigy), reagents, media, disposables, vectors, contract manufacturing and regulatory support. The statement that eight commercially approved products are built on Prodigy | Inference |
| It is serious about spreading manufacturing inside hospitals (point of care) | Installation at seven NRW university hospitals, testing of both centralised and point-of-care manufacturing under S.O.L.A.R.I.S., and a remark about aiming to provide CAR-T to hospitals in India | Inference |
| The CDMO also helps drive equipment sales | Every Bioindustry site is equipped as standard with Prodigy and MACSQuant. When a contracted process moves into a customer's own production, the same equipment is likely to be used | Inference |
| Its own CAR-T also serves largely as a demonstration of the equipment | Miltenyi Biomedicine's candidates are stated to be manufactured on Prodigy. Their place in the business, however, has not been disclosed | Inference |
| Large-scale culture markets such as antibody drugs are not its main battleground | The official material we checked does not mention products or contract services for biologics production with CHO cells and the like | Inference |
In its November 2024 release on Autolus, Miltenyi writes that it did not simply "deliver equipment" but, when Autolus was setting up its manufacturing facility, provided the design philosophy itself, a "ballroom concept" Sourced. A ballroom set-up lines up many Prodigy units in one large room so that manufacturing for different patients runs in parallel. What Miltenyi is selling, then, is not a stand-alone instrument but "how to build the factory", and once that factory starts making an approved product, reagents and disposables sell continuously, in step with the number of patients. From this, our reading is that the company's aim is to "own the standard manufacturing process for cell therapy" Not yet confirmed.
9. Map of cell culture partnerships
Beyond Fig. 2, in 2024 Miltenyi obtained exclusive rights to RNA kits for immune repertoire analysis from MiLaboratories, but as this is a partnership on analysis products rather than cell culture, it is left off the map Sourced. In India, a company executive has said it signed a memorandum of understanding with the Biotechnology Industry Research Assistance Council (BIRAC) and the Department of Biotechnology (DBT), but the release does not describe the content of the memorandum.
10. Technologies, products and services
| Category | Main products and services | What official material says |
|---|---|---|
| Cell manufacturing equipment | CliniMACS Prodigy (closed, automated cell manufacturing instrument), CliniMACS Formulation Unit and CliniMACS Electroporator | Eight commercially approved cell therapies built on Prodigy (Europe, the U.S. and India), more than 200 active clinical trials and more than 400 customised applications |
| Clinical cell separation | CliniMACS Plus, CliniMACS Reagents and the CliniMACS CD34 Reagent System | The CD34 Reagent System is a Humanitarian Use Device (HDE) in the U.S., labelled with a statement that effectiveness has not been demonstrated |
| Media | TexMACS Medium (T cells), NK MACS Medium, StemMACS iPS-Brew XF and PSC-Brew XF (pluripotent stem cells), StemMACS MSC Expansion Medium Kit XF and others | From research use up to MACS GMP grade. 30 products in the research media category alone |
| Culture-related materials | Cytokines and growth factors, T cell stimulation reagents (TransAct), MACSmatrix Laminin 511 (made in CHO cells), cell culture bags and cryopreservation bags | Also offered for clinical manufacturing as part of the MACS GMP product range |
| Automated adherent culture | CliniMACS Prodigy Adherent Cell Culture System (launched 2020) | Nine modules automate coating, seeding, medium exchange and harvest. Validated with mesenchymal stromal cells, pluripotent stem cells and differentiation into dopaminergic progenitors |
| Contract manufacturing (CDMO) | Miltenyi Bioindustry: manufacturing of gene-modified T and NK cells, lentiviral vectors (VSV-G and BaEV pseudotypes, and for in vivo gene therapy), and regulatory support | More than 900 GMP cell therapy batches and more than 350 GMP vector batches (company website). Regulatory experience in more than 45 countries |
The company's media for pluripotent stem cells and mesenchymal cells include a line of products labelled "XF (xeno-free, with no components from non-human animals)", and it sells recombinant laminin 511 made in CHO cells as a scaffold Sourced. In raw materials for regenerative medicine, using fetal bovine serum or mouse-derived scaffolds makes the risk of viral contamination and lot-to-lot variation a heavy quality-control burden. Having serum-free, xeno-free media of defined composition and recombinant protein scaffolds available all the way up to clinical grade from the start is a design that lets culture conditions established in the lab carry straight over into clinical manufacturing. It is also interesting that CHO cells, the workhorse of antibody drug production, are used here as a "factory" for scaffold proteins, an example of the two kinds of cell culture meeting.
11. The risks this company carries
| Risk | Substance | Category |
|---|---|---|
| Results cannot be checked from outside | As a private company it publishes no revenue, profit or investment figures, and the figures it does publish differ between pages and over time | Sourced |
| Customers' products may disappear from the market | Zalmoxis, the first commercial product made using Prodigy, had its European approval withdrawn in 2019 at the request of the marketing authorisation holder (EMA). Equipment and reagent sales depend on the commercial fate of customers' products | Sourced |
| Concentration on the cell therapy market | Its description of products and services centres on cell and gene therapy, with nothing on large-scale culture for antibody drugs. It is exposed if development investment in cell therapy cools | Inference |
| Competing with customers | A group company is developing its own CAR-T, and could end up in the same market as the CAR-T developers who are customers of its CDMO and equipment | Inference |
| Development risk for its own CAR-T | zamto-cel is in pivotal trials and nothing has yet been approved (official Miltenyi Biomedicine website) | Not yet confirmed |
| Unclear production expansion | The timing, scale and cost of using the Laage site and of the training centre in India have not been published | Not yet confirmed |
12. Glossary
- MACS
- Magnetic-Activated Cell Sorting. A technology that selects target cells using magnetic beads coated with antibodies. Miltenyi's founding technology.
- CliniMACS Prodigy
- Miltenyi's instrument that automates cell separation, gene transfer, culture, washing and formulation in a single closed system.
- CDMO
- A company that develops and manufactures drugs under contract. See our explainer on CDMOs for more.
- Lentiviral vector
- A virus-derived carrier used to deliver genes into cells. Widely used in making CAR-T cells.
- CAR-T cells
- T cells given a gene for a receptor that recognises cancer cells. See our explainer on CAR-T cells.
- Point-of-care manufacturing
- Making cell products inside the hospital where the patient is, rather than in a central factory.
- HDE (Humanitarian Device Exemption)
- A U.S. approval pathway for medical devices for diseases with few patients, granted on safety and probable benefit without requiring proof of effectiveness.
- GMP
- The standards for manufacturing control and quality control of medicines. See our explainer on GMP for more.
- XF (xeno-free)
- Media and reagents containing no components derived from animals other than humans. See also our explainer on cell culture media.
13. References
- Miltenyi Biotec About Miltenyi Biotec (company profile: headcount, R&D share, number of locations, number of products, history). https://www.miltenyibiotec.com/JP-en/about-us/about-miltenyi-biotec.html
- Miltenyi Biotec Impressum (legal name, address, commercial register number, managing directors). https://www.miltenyibiotec.com/JP-en/impressum.html
- Miltenyi Biotec "S.O.L.A.R.I.S. launches to advance scalable CAR T cell manufacturing across Europe" (16 July 2026). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/s-o-l-a-r-i-s-launches-to-advance-scalable-car-t-cell-manufacturing-across-europe.html
- Miltenyi Bioindustry "Miltenyi Biotec to support commercial manufacturing of BioOra's CD19 CAR T therapy candidate Atla-cel" (19 August 2026). https://www.miltenyibioindustry.com/en/events/miltenyi-biotec-to-support-commercial-manufacturing-of-bio-ora-s-cd-19-car-t-therapy-candidate-atla-cel.html
- Miltenyi Biotec "Tr1X, Inc. to highlight Miltenyi Biotec CDMO capabilities" (15 September 2026). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/tr1x-inc-to-highlight-miltenyi-biotec-cdmo-capabilities-for-scalable-allogeneic-cell-therapy-manufacturing.html
- Miltenyi Biotec "Miltenyi Biotec to commercially supply CliniMACS Platform to Autolus Therapeutics" (11 November 2024). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-to-commercially-supply-clinimacs-platform-to-autolus-therapeutics-for-their-manufacture-of-fda-approved-aucatzyl-obecabtagene-autoleucel-obe-cel.html
- Miltenyi Biotec "Miltenyi Biotec manufactures lentiviral vector for Adaptimmune's FDA-approved TCR T-cell therapy TECELRA" (10 September 2024). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-manufactures-lentiviral-vector-for-adaptimmune-s-fda-approved-tcr-t-cell-therapy-tecelra-afamitresgeme-autoleucel.html
- Miltenyi Biotec "Miltenyi Biotec opens its first office in India" (27 February 2024). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-opens-its-first-office-in-hyderabad-india-and-plans-invest-in-first-of-its-kind-cgt-coe-for-indian-academia-and-industry.html
- Miltenyi Biotec "Replay's Syena and Miltenyi Biotec enter into exclusive licensing and GMP manufacturing agreement" (18 December 2023). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/replay-s-oncology-focused-product-company-syena-and-miltenyi-biotec-enter-into-exclusive-licensing-and-gmp-manufacturing-agreement.html
- Miltenyi Biotec "New cell therapy network to help protect North Rhine-Westphalia against pandemics" (2 March 2022). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/new-cell-therapy-network-to-help-protect-nrw-against-pandemics.html
- Miltenyi Biotec "Flamm Aerotec sells its property in Laage to biomedical company Miltenyi Biotec" (1 December 2021). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/flamm-aerotec-sells-its-property-in-laage-to-biomedical-company-miltenyi-biotec.html
- Miltenyi Biotec "Miltenyi Biotec offers automated and closed adherent cell culture solutions on CliniMACS Prodigy" (14 July 2020). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-offers-automated-and-closed-adherent-cell-culture-solutions-on-clinimacs-prodigy.html
- Miltenyi Biotec "MolMed and Miltenyi Biotec: EMA approves the utilization of the CliniMACS Prodigy equipment" (1 March 2018). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/molmed-and-miltenyi-biotec-ema-approves-the-utilization-of-the-clinimacs-prodigy-r-equipment.html
- Miltenyi Biotec "Autolus and Miltenyi Biotec sign strategic supply agreement" (April 2018). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/autolus-and-miltenyi-biotec-sign-strategic-supply-agreement.html
- Miltenyi Biotec "Miltenyi Biotec acquires gene therapy assets from Lentigen Corporation" (14 August 2014). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-acquires-gene-therapy-assets-from-lentigen-corporation.html
- Miltenyi Biotec "FDA Approval of CliniMACS CD34 Reagent System" (24 January 2014). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/fda-approval-of-clinimacs-r-cd34-reagent-system.html
- Miltenyi Bioindustry Official website home page (contract manufacturing track record and the division's positioning). https://www.miltenyibioindustry.com/en/
- Miltenyi Bioindustry Our global presence (the five contract manufacturing sites and their facilities). https://www.miltenyibioindustry.com/en/global-facilities.html
- Miltenyi Bioindustry About us (integration of Lentigen and Living Pharma technologies, and the HDE labelling of the CD34 Reagent System). https://www.miltenyibioindustry.com/en/miltenyis-experience/about-us.html
- Miltenyi Biomedicine Official website (development stage of zamto-cel and CAR-T for autoimmune disease, manufacture on Prodigy). https://www.miltenyibiomedicine.com/
- Miltenyi Biotec CliniMACS Prodigy Platform product page (eight commercially approved products, more than 200 clinical trials). https://www.miltenyibiotec.com/JP-en/products/cell-manufacturing-platform/clinimacs-prodigy-platform.html
- Miltenyi Biotec Cell culture media product page. https://www.miltenyibiotec.com/JP-en/products/macs-cell-culture-and-stimulation/cell-culture-media.html
- Miltenyi Biotec Grant management and collaboration (more than 500 collaboration partners, number of public projects). https://www.miltenyibiotec.com/JP-en/about-us/partners-and-collaborators/grant-projects.html
- Miltenyi Biotec Locations (sites by region). https://www.miltenyibiotec.com/JP-en/about-us/locations.html
- European Medicines Agency (EMA) Zalmoxis EPAR (conditional approval on 18 August 2016, withdrawal on 9 October 2019). https://www.ema.europa.eu/en/medicines/human/EPAR/zalmoxis
- Miltenyi Biotec "Miltenyi Biotec and MiLaboratories announce strategic partnership" (29 April 2024). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-and-milaboratories-announce-strategic-partnership-to-advance-next-generation-therapies.html
- Miltenyi Biotec Press releases (list). https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases.html
- Miltenyi Biotec Official website (source of the logo image). https://www.miltenyibiotec.com/
14. Claim-to-source audit
| Claim in the article | Category | Source |
|---|---|---|
| Legal name Miltenyi Biotec B.V. & Co. KG, head office address, commercial register number HRA 34194 | Sourced | Reference 2 https://www.miltenyibiotec.com/JP-en/impressum.html |
| Founded 1989, more than 5,000 employees, 23% in R&D, 27 locations, 71 countries served, the product counts (more than 21,000 / more than 18,000), more than 120,000 patients | Sourced | Reference 1 https://www.miltenyibiotec.com/JP-en/about-us/about-miltenyi-biotec.html |
| History (2002 Teterow GMP facility, 2014 technology acquisitions, 2017 adapter CAR T technology, 2018 Cell Factory manufacturing authorisation, 2019 founding of Miltenyi Biomedicine, 2021 San Jose Cell Factory) | Sourced | Reference 1 https://www.miltenyibiotec.com/JP-en/about-us/about-miltenyi-biotec.html |
| More than 1,300 employees in 22 countries (January 2014) | Sourced | Reference 16 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/fda-approval-of-clinimacs-r-cd34-reagent-system.html |
| More than 1,400 employees in 25 countries (August 2014), the acquisition of Lentigen's business and the founding of Lentigen Technology, Inc. | Sourced | Reference 15 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-acquires-gene-therapy-assets-from-lentigen-corporation.html |
| More than 4,900 employees in 24 countries (September 2024), commercial manufacture of vector for TECELRA, the Gaithersburg site passing the FDA pre-license inspection, and FDA approval of TECELRA on 1 August 2024 | Sourced | Reference 7 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-manufactures-lentiviral-vector-for-adaptimmune-s-fda-approved-tcr-t-cell-therapy-tecelra-afamitresgeme-autoleucel.html |
| More than 5,000 employees in 24 countries (2026), and an outline of S.O.L.A.R.I.S. (13 partners, coordinator, seven modules, budget, duration) | Sourced | Reference 3 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/s-o-l-a-r-i-s-launches-to-advance-scalable-car-t-cell-manufacturing-across-europe.html |
| The commercial vector supply agreement with BioOra, and more than 500 GMP batches (50 L and 200 L) at the Gaithersburg site | Sourced | Reference 4 https://www.miltenyibioindustry.com/en/events/miltenyi-biotec-to-support-commercial-manufacturing-of-bio-ora-s-cd-19-car-t-therapy-candidate-atla-cel.html |
| The Tr1X collaboration, and the integrated offering from vector design to regulatory support | Sourced | Reference 5 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/tr1x-inc-to-highlight-miltenyi-biotec-cdmo-capabilities-for-scalable-allogeneic-cell-therapy-manufacturing.html |
| Commercial supply of the full Prodigy platform for manufacture of Autolus's AUCATZYL, the supply agreement since 2018, and provision of the ballroom concept | Sourced | Reference 6 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-to-commercially-supply-clinimacs-platform-to-autolus-therapeutics-for-their-manufacture-of-fda-approved-aucatzyl-obecabtagene-autoleucel-obe-cel.html |
| The 2018 long-term supply agreement with Autolus | Sourced | Reference 14 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/autolus-and-miltenyi-biotec-sign-strategic-supply-agreement.html |
| The first office in India and the planned investment in a training centre, the mention of MoUs with BIRAC and DBT, and the statement of more than 10,000 patients a year | Sourced | Reference 8 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-opens-its-first-office-in-hyderabad-india-and-plans-invest-in-first-of-its-kind-cgt-coe-for-indian-academia-and-industry.html |
| The exclusive licence of the PRAME TCR to Syena and GMP manufacture of TCR-NK cells | Sourced | Reference 9 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/replay-s-oncology-focused-product-company-syena-and-miltenyi-biotec-enter-into-exclusive-licensing-and-gmp-manufacturing-agreement.html |
| Technology and training for seven NRW university hospitals, and €7.75 million of state funding | Sourced | Reference 10 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/new-cell-therapy-network-to-help-protect-nrw-against-pandemics.html |
| Acquisition of the Laage factory site (51,000 m²), and about 500 staff at Teterow | Sourced | Reference 11 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/flamm-aerotec-sells-its-property-in-laage-to-biomedical-company-miltenyi-biotec.html |
| Launch of the adherent cell culture system, its nine modules and the cell types validated | Sourced | Reference 12 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-offers-automated-and-closed-adherent-cell-culture-solutions-on-clinimacs-prodigy.html |
| EMA approval of Prodigy for the commercial manufacture of Zalmoxis (Prodigy's first commercial manufacturing use) | Sourced | Reference 13 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/molmed-and-miltenyi-biotec-ema-approves-the-utilization-of-the-clinimacs-prodigy-r-equipment.html |
| Conditional approval of Zalmoxis in 2016 and withdrawal in 2019 | Sourced | Reference 25 https://www.ema.europa.eu/en/medicines/human/EPAR/zalmoxis |
| FDA approval of the CliniMACS CD34 Reagent System as a Humanitarian Use Device (HDE) | Sourced | References 16 and 19 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/fda-approval-of-clinimacs-r-cd34-reagent-system.html |
| Bioindustry's contract manufacturing record (more than 900 cell therapy batches, more than 350 vector batches) and regulatory experience in more than 45 countries | Sourced | Reference 17 https://www.miltenyibioindustry.com/en/ |
| The five contract manufacturing sites and their facilities (floor area, cleanroom grade) | Sourced | Reference 18 https://www.miltenyibioindustry.com/en/global-facilities.html |
| Integration of Lentigen and Living Pharma technologies, and the statement of more than 6,000 patients a year | Sourced | Reference 19 https://www.miltenyibioindustry.com/en/miltenyis-experience/about-us.html |
| Miltenyi Biomedicine's zamto-cel (pivotal trials) and CAR-T for autoimmune disease, manufactured on Prodigy | Sourced | Reference 20 https://www.miltenyibiomedicine.com/ |
| Eight commercially approved products built on Prodigy, more than 200 clinical trials, more than 400 customised applications | Sourced | Reference 21 https://www.miltenyibiotec.com/JP-en/products/cell-manufacturing-platform/clinimacs-prodigy-platform.html |
| Media products (XF products, laminin 511 and others), 30 research media products, and the product categories of cytokines, stimulation reagents and culture bags | Sourced | Reference 22 https://www.miltenyibiotec.com/JP-en/products/macs-cell-culture-and-stimulation/cell-culture-media.html |
| Launch of the GMP-grade T cell stimulation reagent TransAct (the April 2017 item in the press release list) | Sourced | Reference 27 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases.html |
| More than 500 collaboration partners, more than 50 European projects, more than 60 national projects | Sourced | Reference 23 https://www.miltenyibiotec.com/JP-en/about-us/partners-and-collaborators/grant-projects.html |
| Site structure by region | Sourced | Reference 24 https://www.miltenyibiotec.com/JP-en/about-us/locations.html |
| Exclusive rights to MiLaboratories' RNA kits (left off Fig. 2 as an analysis product) | Sourced | Reference 26 https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/miltenyi-biotec-and-milaboratories-announce-strategic-partnership-to-advance-next-generation-therapies.html |
| The three types of cell culture company, and classing Miltenyi as mainly a supplier and secondarily a CDMO | Our calculation | Our own classification. Companies shown are examples from the 20 in this series |
| Headcount up about 3.8 times in around twelve and a half years, and about 1,150 or more R&D staff | Our calculation | Our calculation (from figures published in References 1 and 16) |
| Revenue, profit, R&D spending and capital expenditure | Not yet confirmed | Not on the official website or in official announcements. This article makes no estimate https://www.miltenyibiotec.com/JP-en/about-us/about-miltenyi-biotec.html |
| Start of production and capacity at Laage, the investment in India, and the timing of a zamto-cel filing | Not yet confirmed | Not in official announcements https://www.miltenyibiotec.com/JP-en/about-us/newsroom/press-releases/flamm-aerotec-sells-its-property-in-laage-to-biomedical-company-miltenyi-biotec.html |
| Investments in start-ups, and business for antibody drugs (CHO cells) | Not yet confirmed | Not in the official material we checked. This article does not conclude that none exists https://www.miltenyibiotec.com/JP-en/about-us/about-miltenyi-biotec.html |
| The readings about owning the standard manufacturing process, emphasis on point of care, the CDMO driving equipment sales, its own CAR-T as a demonstration of the equipment, and large-scale culture not being its main battleground | Inference | This article's interpretation of statements in References 1, 3, 5, 6, 18 and 20 |
| The risks of concentration on the cell therapy market and of competing with customers | Inference | This article's interpretation of the business structure |
| The view that XF media and recombinant laminin ease the move from research to the clinic | Inference | This article's commentary on the product line-up in Reference 22 |
Last updated 24 September 2026 / Troy Technical
Because Miltenyi Biotec is a private company, the figures in this article are based on its official website and official press releases (including those of its division and group company) and on public documents from the European Medicines Agency. No research-firm estimates or press-based figures have been used. Passages marked "Inference" are this article's interpretation of primary sources, not statements made by the company.