ProBioGen gains operational control of Berlin’s advanced therapy manufacturing hub
German biotechnology company ProBioGen has been selected to design, construct, and operate the GMP manufacturing facility at Berlin’s new Centre for Gene and Cell Therapies, establishing a critical infrastructure node for translating advanced therapeutic research into clinical applications across Europe.
The Berlin Centre for Gene and Cell Therapies (BC GCT) represents an ambitious convergence of academic research, industrial partnership, and manufacturing excellence, with ProBioGen positioned as the operational cornerstone of its 4,600-square-metre good manufacturing practice (GMP) production facility. This strategic appointment consolidates Berlin’s emergence as a European hub for advanced therapy medicinal products (ATMPs), directly supporting Germany’s National Strategy for gene- and cell-based therapies.
The BC GCT initiative emerges from a collaboration between Charité – Universitätsmedizin Berlin, Bayer AG, and the Berlin Institute of Health at Charité (BIH), designed to accelerate the translation of gene and cell therapies from laboratory discovery through clinical development. The centre will integrate state-of-the-art manufacturing capabilities with comprehensive incubation services, providing start-ups and established biotechnology companies with essential infrastructure for therapeutic development.
Manufacturing capabilities span diverse therapeutic modalities
ProBioGen’s operational mandate encompasses the development and manufacturing of clinical materials across multiple therapeutic platforms, including viral vectors, autologous and allogeneic cell products, non-viral gene delivery technologies, and other biotherapeutic modalities.
The company’s established presence in Berlin-Weißensee provides strategic proximity to the new facility, enabling seamless technology transfer and operational synergies.
“Being chosen to operate the GMP manufacturing facility at the Berlin Centre 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.” The centre’s design philosophy emphasises comprehensive support for therapeutic development, extending beyond manufacturing to include process development, regulatory compliance guidance, clinical trial preparation, intellectual property management, and business development consultation. This integrated approach addresses critical bottlenecks that frequently impede the translation of promising therapeutic concepts into viable clinical products.
Strategic positioning within European biotechnology infrastructure
Prof Christopher Baum, Scientific Director of the BIH and Chief Translational Research Officer of Charité, emphasised the partnership’s strategic significance: “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.”
The facility’s location near Bayer’s Nordhafen campus creates additional opportunities for collaboration and knowledge exchange, whilst the Federal Ministry of Research, Technology, and Space and the State of Berlin provide foundational funding support. Construction commences in 2025, with operational readiness anticipated by 2028.
Gene and cell therapies represent transformative approaches to treating previously intractable medical conditions by targeting genetic or epigenetic disease mechanisms directly. The therapeutic modalities address fundamental biological processes, offering curative potential for patients with severe hereditary disorders, certain cancers, and degenerative conditions.
ProBioGen’s appointment reflects the company’s established expertise in cell line development, process optimisation, and GMP manufacturing across therapeutic proteins, antibodies, viral vectors, and vaccines. The integration of manufacturing operations with the centre’s research and incubation activities creates a comprehensive ecosystem supporting therapeutic innovation from conceptual development through clinical application.
