CDMO Services

Miltenyi Biotec manufactures lentiviral vector for Adaptimmune’s FDA-approved TCR T-cell therapy TECELRA® (afamitresgeme autoleucel)

Miltenyi Biotec will supply lentiviral vector for TECELRA® (afamitresgene autoleucel), the first-ever TCR T-cell therapy for solid tumors approved by FDA on August 1, 2024.
The commercial manufacturing of the lentiviral vector used in production of TECELRA is performed by Miltenyi Bioindustry, the global division of Miltenyi Biotec dedicated to contract development and manufacturing organization (CDMO) services for the manufacturing of viral vectors and gene-engineered cell therapy products.

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We have manufactured over 700 GMP cell therapy batches, helping our clients treat patients all around the world

We have manufactured over 400 batches of GMP lentiviral vector to support over 100 clinical trials

With regulatory experience in over 55 countries, we help you get your therapy to patients, wherever they may be

Your full-service CDMO partner

Miltenyi Bioindustry supports all efforts, from pre-clinical to commercial scale, as a full-service provider for the development and manufacturing of lentiviral vectors (LVVs) and cell and gene therapy (CGT) products. As a globally active CDMO (Contract Development and Manufacturing Organization) with 25 years of extensive know-how, we are helping to shape this rapidly growing arena. We leverage the latest technology platforms to make your vision of commercial-scale manufacturing a reality. We are a division of Miltenyi Biotec, a pioneering innovator and provider of cell processing and analytical platforms, LVVs, and ancillary materials in this field.

Cell and gene therapy process development and manufacturing

We make your product ready for clinical trials and towards commercial roll-out. Miltenyi Biotec’s proven manufacturing and analysis platforms comprise closed and integrated solutions that help advance your process to commercial scale.

Our cell therapy services

Lentiviral vector optimization and manufacturing

From LVV design and selection to small-scale evaluation and commercial-scale manufacturing, we support customers at various scales. With decades of experience and a scalable LVV platform, we offer fast and consistent production of high-quality vectors with minimal process development.

Our LVV services

Regulatory support services

Our global quality and regulatory teams support your project from pre-IND to market approval. We have the experience and the documentation to accelerate your regulatory submissions.

Our regulatory support

Our mission

Our mission is to improve the availability and affordability of advanced CGT products. We do so by providing solutions that propel manufacturing of cell therapies for translation into the clinic and the market. We provide services, expertise, and technologies to leading researchers, biotech companies, and large corporates to take their cell and gene therapy products to the next level.

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CDMO services to actualize your cell and gene therapy program