Berlin, Germany – September 16, 2025
ProBioGen and the Berlin Institute of Health at Charité (BIH) announced today 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.
The Berlin Center for Gene and Cell Therapies (BC GCT) is an innovative public-private partnership that brings together research, development, and production of gene and cell therapies under one roof. The initiative was launched by Bayer AG, Charité – Universitätsmedizin Berlin, and the Berlin Institute of Health at Charité. With a start-up incubator offering space for 15 to 20 companies, as well as a GMP-certified manufacturing facility, the center creates optimal conditions for the translation of novel therapies from the lab to clinical application. Funding from the State of Berlin and the Federal Ministry for Research, Technology, and Space supports the expansion of the infrastructure and ensures the long-term quality and safety of medicinal products. The GMP facility is operated by ProBioGen AG, ensuring compliance with international quality standards. The building is being developed by iQ spaces as project developer and is located on the Bayer campus in Berlin, with completion scheduled for 2028.
The Berlin Institute of Health at Charité (BIH) is dedicated to biomedical translation. Its mission is to translate research findings into personalized prevention, diagnostics, and therapies to benefit patients and provide the scientific community with effective tools. With approximately 750 employees, the BIH specializes in translational method development, precision medicine, regenerative therapies, and biomedical data science. Closely integrated with Charité, the BIH promotes excellent research and facilitates the accelerated transfer of new discoveries into clinical practice through its supporting platforms and programs. Through these efforts, the BIH builds strong partnerships and fosters innovation-driven medicine in both national and international context.
ProBioGen is a Berlin-based biotech company, a Contract Development and Manufacturing Organization (CDMO) and technology provider that operates globally. It specializes in developing and manufacturing biopharmaceutical active ingredients, viral vectors and vaccines, while also developing and outlicensing proprietary technologies that enhance product quality and features. Founded in 1994 as a spin-off of Charité, a widely recognized hospital known as one of the best in the world. More than 30 years later, 300 employees work at ProBioGen's two locations in Berlin. Every day, they contribute to the creation of new therapies in medicine and groundbreaking innovations worldwide through their creative and meticulous work. ProBioGen's growth strategy is driven by the expansion of the service value chain through organic growth and potential acquisitions. Diversification is a complementary driver, while the focus is strict on enabling the development of biopharmaceuticals for tomorrow.
For more information about ProBioGen visit our website and follow us on LinkedIn.
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ProBioGen Contact: Dr. Gabriele Schneider |
ProBioGen Press Contact: Sarah Wandrey |