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), 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.

"Being chosen to operate the GMP manufacturing facility at the Berlin Center for Gene and Cell Therapies is a privilege and a responsibility we embrace with full commitment," said Dr. Alfred Merz, Chief Executive Officer of ProBioGen. "This facility will be more than a place of production – it will be a catalyst for turning breakthrough science into real treatments for patients. We are proud to bring our in-depth understanding of science, expertise, technologies, resources, and dedication to support the center's mission and to contribute to Germany’s National Strategy for gene- and cell-based therapies."

"We are thrilled to have ProBioGen as our operational partner for the GMP facility at the Berlin Center for Gene and Cell Therapies," says Prof. Christopher Baum, Scientific Director of the BIH and Chief Translational Research Officer of Charité. "ProBioGen's strong track record and extensive expertise will ensure that start-ups and researchers have access to the development and production capacities, know-how, and quality standards required to translate scientific breakthroughs into advanced therapies. Through this partnership, we are making a significant contribution to strengthening Berlin's position as a leading life sciences hub and to implementing the High-Tech Agenda." said Prof. Dr. Christopher Baum, Chair of the BIH Board of Directors and Chief Translational Research Officer at Charité.

GCTs are among the most promising fields in modern medicine, targeting the genetic or epigenetic causes of disease and offering curative potential for patients with severe or currently untreatable conditions. Germany's National Strategy for gene- and cell-based therapies aims to strengthen the entire value chain - from basic research through to patient access - and secure the country's position as a global leader in this transformative area. As part of this strategy, the Berlin Center for Gene and Cell Therapies will turn this potential into practice.

Funded by the Federal Ministry of Research, Technology, and Space and the State of Berlin, the center will be located in close proximity to Bayer's Nordhafen campus, with construction starting in 2025 and opening planned for 2028. By combining modern laboratories and GMP manufacturing capacity with targeted expertise in process development, regulatory compliance, clinical trial readiness, intellectual property, and business development, it will give innovators the capabilities and guidance they need to bring therapies from concept to clinic with speed and confidence.