First cleanroom for CAR-T cell production in Hamburg - also for people with HIV when indicated

Location PROVIREX in Hamburg (Copyright: PROVIREX; Image rights: PROVIREX Genome Editing Therapy)

The CAR-T cell therapy has been expanding treatment options in Germany since 2018 for people with certain hematologic-oncological diseases. Cells for the personalized therapy are currently mostly produced in U.S. laboratories. This requires complex logistics and is associated with high costs. The biotech company PROVIREX has completed new cleanrooms in Hamburg, creating new capacities for the production of CAR-T cells in Germany. This allows the cells to be available more quickly and can be administered directly to patients without prior cryopreservation due to transport. Domestic production saves valuable time for patients and may result in better cell quality, which could positively affect prognosis. Additionally, shortened transport routes and the elimination of cryopreservation reduce costs. Another advantage: the new cleanrooms have safety level S3**, enabling PROVIREX to become the first company in Germany to produce CAR-T cells for people with HIV in the future. To fully exploit the future innovation and growth potential of CAR-T cell production, PROVIREX is open to strategic partnerships with academic institutions, clinical trial centers, and other stakeholders in the field of cell and gene therapy.

PROVIREX is a spin-off of the Leibniz Institute for Virology (LIV) in Hamburg, which specializes in "Advanced Therapy Medicinal Products" (ATMPs). The focus is on a technology developed by the founders for the cure of HIV and potentially life-threatening persistent viral diseases. For this purpose, PROVIREX has established a unique S3** cleanroom in Germany. This infrastructure can be expanded for the production of CAR-T cells, including for people with HIV with appropriate indications such as lymphoma.

The production of CAR-T cells today - complex, time-consuming, and costly

Currently, CAR-T cell manufacturing is mostly carried out in the USA. The process depends on complex logistics and involves high costs and uncertainties regarding smooth operation. The cells needed for production must be cryopreserved for transport to the USA and for subsequent return. This results in losses in cell viability and efficacy.(1) The production of the cells themselves takes about two weeks. Additional transport and waiting times are involved. From blood collection to infusion of CAR-T cells, up to 30 days can pass—and often even more due to limited capacities of manufacturers—before patients with aggressive diseases receive the urgently needed therapy.(1) Currently, five out of 44 qualified CAR-T therapy treatment centers in Germany(2) have approval to produce the cells themselves.(3-7) With the planned expansion of capacities for CAR-T cell production in Germany by PROVIREX, many more patients could soon benefit from the therapy, including people living with HIV. Domestic production promises time and cost savings, as well as higher quality and quantity of cells.

About CAR-T cell therapy

The CAR (Chimeric Antigen Receptor) T-cell therapy is used to treat patients with certain relapsed or refractory B-cell neoplasms such as diffuse large B-cell lymphoma (DLBCL), acute lymphoblastic B-cell leukemia (ALL), or multiple myeloma.(8) In this personalized therapy, T cells are taken from patients and genetically modified ex vivo so that they recognize the surface antigen CD19, which is often present on lymphoma cells, via an artificial ("chimeric") receptor. The target antigen for multiple myeloma is B-cell maturation antigen (BCMA). The cells are expanded in the laboratory and administered to patients via infusion. When the CAR-T cells come into contact with cancer cells, they are destroyed.

Cost-effective, rapid CAR-T cell production for individual needs

In June 2025, PROVIREX completed the construction of the cleanrooms at the tecHHub in Hamburg-Altona Innovation Park. Planning and implementation were carried out in close coordination with the Hamburg Authority for Environment, Climate, Energy, and Agriculture (BUKEA) and the Hamburg Authority for Justice and Consumer Protection. PROVIREX aims to achieve GMP (Good Manufacturing Practice) certification and official approval for CAR-T cell production in Q3 2026. The facility features fully equipped GMP laboratories of four cleanroom classes A to D and associated laboratories for quality control. For the production of CAR-T cells, there is capacity for a total of seven automated devices of the CliniMACS Prodigy® type(11) from Miltenyi Biotec, operated in cleanroom class C. The S3** classification allows for the production of CAR-T cells also for people with HIV, provided appropriate indications are present. Building on the successful collaboration so far, Miltenyi Biotec and PROVIREX are planning discussions on a strategic partnership aimed at advancing innovative solutions in cell and gene therapy through joint development activities. "PROVIREX is an entrepreneur-led biotech company benefiting from flat hierarchies and short communication channels—enabling quick decisions and flexible responses, even to individual patient needs. The low overhead structures also mean less bureaucracy," emphasizes Dr. Jan-Uwe Claas, Partner CEO of the company. "We are now available for discussions on future cooperation projects or partnerships. Our offer is directed not only at CAR-T therapy centers and research institutions but also at pharmaceutical companies for the manufacturing of CAR-T cells for clinical trials," says Dr. Claas.

References

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(2) CAR-T cell therapy in Austria and Germany. Available at: https://car-t-cell.com/zentren; Last accessed: 16.06.2025
(3) Notification from University Hospital Cologne. Available at: https://ots.de/n5goKX; Last accessed: 20.06.2025
(4) Notification from University Hospital Heidelberg. Available at: https://ots.de/v2FEC5; Last accessed: 20.06.2025
(5) Notification from University Hospital Tübingen. Available at: https://ots.de/BUHXvB; Last accessed: 20.06.2025
(6) Notification from University Hospital Erlangen. Available at: https://ots.de/tTfKI2; Last accessed: 20.06.2025
(7) Notification from University of Duisburg-Essen. Available at: https://ots.de/KW3aqx; Last accessed: 20.06.2025
(8) Borchmann P. CAR-T cell therapy. Available at: https://lymphome.de/therapieverfahren/6-car-t-zell-therapie; Last accessed: 09.06.2025
(9) PROVIREX: Precise genome-editing technology to cure HIV. Available at: https://www.nature.com/articles/d43747-025-00022-4; Last accessed: 09.06.2025
(10) Karpinski J, Hauber I, Chemnitz J, et al. Directed evolution of a recombinase that excises the provirus of most HIV-1 primary isolates with high specificity. Nat Biotechnol. 2016;34(4): 401-409
(11) Miltenyi Biotec. CliniMACS Prodigy® Platform. Available at: https://ots.de/54QWhl; Last accessed: 30.06.2025