First cleanroom for CAR-T cell production in Hamburg – also for people with HIV if indicated
CAR-T cell therapy has been expanding the treatment options for people with certain haemato-oncological diseases in Germany since 2018. To date, the cells for personalized therapy have mostly been produced in US laboratories. This requires complex logistics and is associated with high costs. The biotech company PROVIREX has built new cleanrooms in Hamburg, creating new capacity for the production of CAR-T cells in Germany. This means that the cells are available faster and can be administered directly to patients without the need for prior transport-related cryopreservation. Domestic production means that patients gain valuable time and may benefit from higher cell quality, which could have a positive effect on prognosis. Costs are also reduced due to shorter transport routes and the omission of cryopreservation. Another advantage is that the new cleanrooms have safety level S3**, making PROVIREX the first company in Germany to be able to produce CAR-T cells for people with HIV in the future. In order to fully exploit the future innovation and growth potential of CAR-T cell production, PROVIREX is open to strategic partnerships with academic institutions, clinical study centers and other players in the field of cell and gene therapy.
PROVIREX is a spin-off from the Leibniz Institute of Virology (LIV) in Hamburg that specializes in advanced therapy medicinal products (ATMPs). The focus is on a technology developed by the founders to cure HIV and potentially life-threatening persistent viral diseases. For this purpose, PROVIREX has built an S3** cleanroom that is unique in Germany. The use of this infrastructure can be expanded for the production of CAR-T cells, including for people with HIV with associated indications such as lymphoma.
The production of CAR-T cells today: Complex, time-consuming and cost-intensive
CAR-T cell production has so far mostly taken place in the USA. The process is dependent on complex logistics and is associated with high costs and uncertainties. For example, the cells required for production must be cryopreserved for transport to the USA and the subsequent return transport. This is associated with losses in terms of viability and functionality of the cells.1 The production of the CAR-T cells themselves takes around two weeks. There are also transport and waiting times. It can take up to 30 days from blood collection to infusion of the CAR T cells – and often even longer due to limited manufacturer capacities – before patients with aggressive disease receive the urgently needed therapy.1
Of the 44 qualified CAR T cell therapy treatment centers in Germany2, five currently have permission to produce the cells themselves.3-7 The expansion of CAR-T cell production capacities in Germany planned by PROVIREX could soon enable significantly more patients to benefit from the therapy, including people living with HIV. Thanks to domestic production, time and cost savings as well as a potentially higher quality and quantity of cells can be expected.
Cost-efficient, fast CAR-T cell production for individual requirements
PROVIREX completed the construction of the cleanrooms in the tecHHub at the Hamburg-Altona Innovation Park in June 2025. The planning and realization was carried out in close coordination with the Hamburg Ministry of the Environment, Climate, Energy and Agriculture (BUKEA) and the Ministry of Justice and Consumer Protection. PROVIREX is aiming for GMP (Good Manufacturing Practice) certification and official authorization to produce CAR-T cells in the third quarter of 2026. The facility has optimally equipped GMP laboratories of the four cleanroom classes A to D and associated quality control laboratories. For CAR-T cell production, there is capacity for a total of seven automated CliniMACS Prodigy®11 devices from Miltenyi Biotec, which are operated in cleanroom class C. The S3** classification also allows the production of CAR-T cells for people with HIV. Building on the successful collaboration to date, Miltenyi Biotec and PROVIREX are planning a strategic partnership with the aim of advancing pioneering solutions in the field of cell and gene therapy through joint development activities. “PROVIREX is an entrepreneurial biotech company that benefits from flat hierarchies and short communication channels – and thus enables quick decisions and flexible reactions 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 aimed not only at CAR-T cell therapy centers and research institutions, but also at pharmaceutical companies for the production of CAR-T cells for clinical trials,” says Dr. Claas.
Further information: https://s3ltec.de/
