ProBioGen and the Berlin Institute of Health at Charité (BIH) announced that ProBioGen has been selected to operate the process development and Good Manufacturing Practice (GMP) production facility for Advanced Therapy Medicinal Products (ATMPs) at the Berlin Center for Gene and Cell Therapies (BC GCT). The BC GCT is a joint initiative of Charité – Universitätsmedizin Berlin, Bayer AG, and BIH.

As part of the agreement, ProBioGen will oversee the design, construction, and operation of the 4,600-square-meter GMP manufacturing unit. This facility will serve as a cornerstone of the BC GCT, envisioned as a European hub for translational medicine, bridging cutting-edge research with clinical applications. The center will combine state-of-the-art GMP-certified production with modern laboratory and office spaces, incubator support, and tailored mentoring for selected start-ups, enabling the rapid advancement of innovative therapies.

ProBioGen will be responsible for the build-out and certification of the GMP unit, which will support the development and manufacturing of a wide range of therapeutic modalities, including viral vectors, autologous and allogeneic cell therapies, non-viral technologies, and other biotherapeutics. Once operational, the company will manage daily operations, provide GMP-compliant manufacturing and process development services, and deliver training and support to early-stage start-ups and established industry partners. In the interim, ProBioGen will continue to provide services from its Berlin-Weißensee headquarters.

As a fully integrated Berlin-based contract development and manufacturing organization (CDMO), ProBioGen brings decades of expertise in cell line and process development, and in the GMP production of therapeutic proteins, antibodies, viral vectors, and vaccines. Known for its proprietary technologies and excellence in technology transfer, the company’s leadership of the GMP facility will create strong synergies with its existing operations and further enhance Berlin’s role as a global hub for life sciences innovation.

Gene and cell therapies represent one of the most promising fields in modern medicine, with the potential to address genetic or epigenetic causes of disease and provide curative solutions for severe or currently untreatable conditions. Germany’s National Strategy for gene- and cell-based therapies aims to strengthen the entire innovation chain, from basic research to patient access, positioning the country as a global leader in this transformative area.

The Berlin Center for Gene and Cell Therapies is funded by the Federal Ministry of Research, Technology, and Space and the State of Berlin. Located near Bayer’s Nordhafen campus, construction of the facility will begin in 2025, with the opening planned for 2028. By combining modern laboratories, GMP manufacturing capacity, regulatory expertise, and business development support, the BC GCT will provide innovators with the infrastructure and guidance needed to accelerate the journey from concept to clinic.