Contributing manufacturing technologies and clinical trial experience to a European network of Centres of Excellence for ATMPs

Miltenyi brings deep, end‑to‑end technical, scientific, and clinical expertise that is highly relevant for a European network of Centres of Excellence for ATMPS. From a technical and manufacturing perspective, Miltenyi Biotec has more than 25 years of experience in developing automated, closed, and GMP‑compliant platforms for cell and gene therapy production, with its technologies used in hundreds of clinical trials and routine clinical manufacturing settings across Europe. These platforms enable standardized, reproducible ATMP manufacturing, reduce operator‑dependent variability, and support both centralized and point‑of‑care production models at academic hospitals and specialized treatment centers.

Technically, Miltenyi Biotec has built integrated workflows spanning cell isolation, activation, genetic modification, expansion, and comprehensive in‑process and release analytics. This systems‑level approach allows complex ATMP processes to be translated from research into clinical‑grade manufacturing using harmonized methods, facilitating comparability across sites and supporting multi‑center studies. Miltenyi’s tools and reagents are embedded in many European translational research programs, enabling rapid prototyping of new ATMP concepts and early de‑risking of manufacturing and quality attributes. We are partners of Join4ATMP and T2Evolve.

Clinically, Miltenyi Biomedicine extends this expertise by acting as a therapy developer, advancing CAR‑T and next‑generation cell therapies into clinical trials for oncology and autoimmune diseases. Its programs are executed through multi‑center, cross‑border clinical trials and rely on standardized, GMP‑compliant manufacturing processes, providing practical experience in coordinating clinical operations, quality systems, and logistics across sites. Manufacturing of these therapies on the same automated platforms used broadly in Europe demonstrates how technical standardization can directly support scalable clinical development and patient access.

Together, this combination of enabling technology, scientific workflow integration, and real‑world clinical development experience positions Miltenyi as a strong technical and translational partner for a European ATMP CoE network. Miltenyi can contribute validated manufacturing solutions, scientific best practices, and clinical execution know‑how that support harmonization, interoperability, and faster translation of advanced therapies to patients across Europe.

Additional Information is available on Miltenyi’s homepage:

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