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ProBioGen and the Berlin Institute of Health at Charité (BIH) announces 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), a joint project of Charité –Universitätsmedizin Berlin, Bayer AG and Berlin Institute of Health at Charité (BIH). ProBioGen will oversee the design, lead the construction, and subsequently operate the 4,600-square-meter GMP manufacturing unit — an integral part of the center, envisioned as a powerhouse for translational medicine and innovation in Berlin and beyond.
The Berlin Center for Gene and Cell Therapies (BC GCT) will be a unique European hub uniting research, development, and manufacturing to accelerate the translation of ATMPs from discovery to clinical application. Alongside its state-of-the-art GMP-certified production facility, it will feature a fully equipped incubator with modern laboratories and office spaces which also offer mentoring and consulting opportunities to selected start-ups. As such, the center shall provide start-ups and clinical innovators with the infrastructure, expertise, and support to bring innovative therapies to patients faster and with greater success rates.
Under the awarded contract, ProBioGen will be responsible for the build-out and certification of the GMP unit, enabling the development and manufacturing of clinical material for a range of therapeutic gene- and cell-based modalities, including viral vectors, autologous and allogeneic cell products, non-viral technologies, and other biotherapeutics. Once operational, ProBioGen will manage its daily operations and ongoing maintenance, providing process development and GMP-compliant manufacturing services as well as training and support for early-stage start-ups and established industry clients. Even before the GMP facility opens, ProBioGen will already be providing services from its Berlin-Weißensee headquarters.
As a fully integrated Berlin-based contract development and manufacturing organization (CDMO), ProBioGen operates its own facilities near the BC GCT. With decades of biopharmaceutical experience, the company specializes in cell line and process development, and in manufacturing of therapeutic proteins, antibodies, viral vectors, and vaccines. Recognized for proprietary technologies that enhance product quality and features, and for excellence in GMP operations and technology transfer, ProBioGen's expansion into operating the center's GMP unit — located close to its existing sites — will create synergies, increase flexibility, and enable seamless scale-up from discovery to clinical manufacturing.
