CAR T-cell therapy has been revolutionizing the treatment of certain blood cancers in Germany since 2018, but the cells are usually produced in the USA, which results in time-consuming logistics and high costs. The Hamburg-based biotech company PROVIREX has completed new clean rooms in the Hamburg-Altona Innovation Park to produce CAR-T cells in Germany for the first time. This shortens transportation routes, eliminates the need for cryopreservation and could improve cell quality, which can have a positive impact on the prognosis of patients. It also reduces costs. The S3** safety level of the clean rooms is unique, allowing PROVIREX to be the first company in Germany to produce CAR-T cells for people with HIV for corresponding indications such as lymphoma.

CAR T-cell therapy is aimed at relapsed or refractory B-cell neoplasms such as diffuse large B-cell lymphoma, acute lymphoblastic leukemia or multiple myeloma. This involves taking the patient’s own T cells, genetically modifying them in the laboratory to recognize cancer antigens such as CD19 or BCMA, multiplying them and returning them by infusion, where they destroy cancer cells. Current production in the USA requires cryopreservation, which can impair cell viability, and takes up to 30 days or longer, including transportation. In Germany, only five of 44 qualified therapy centers currently have their own manufacturing license. PROVIREX is planning to significantly expand its capacities.

The new cleanrooms, equipped with class A to D GMP laboratories and seven automated CliniMACS Prodigy® devices from Miltenyi Biotec, meet the highest quality standards. PROVIREX is aiming for GMP certification in the third quarter of 2026. The collaboration with Miltenyi Biotec will be deepened through a strategic partnership to drive innovative solutions in cell and gene therapy. PROVIREX is open to collaborations with academic institutions, study centers and pharmaceutical companies to fully exploit the potential of the therapy.

As a spin-off of the Leibniz Institute of Virology, PROVIREX specializes in advanced therapeutic products, in particular for curing HIV through precise genome editing. The S3** cleanrooms, unique in Germany, support this mission and enable CAR-T cell production for a broader patient population. Flat hierarchies and low bureaucracy allow PROVIREX to respond flexibly to individual needs, making therapy faster and more cost-efficient.

Read also:

Car-T-cell therapy can cause T-cell lymphoma in rare cases – MedLabPortal

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