ProBioGen to run GMP facility at Berlin Center for Gene and Cell Therapies

ProBioGen, a Berlin-based contract development and manufacturing organization (CDMO), said it has been selected to design, build and operate the good manufacturing practice (GMP) unit at the Berlin Center for Gene and Cell Therapies (BC GCT). The 4,600-square-meter facility will provide process development and GMP production of advanced therapy medicinal products (ATMPs).

The BC GCT, a joint project of Charité–Universitätsmedizin Berlin, Bayer AG and the Berlin Institute of Health at Charité (BIH), reportedly is being established as a European hub for translational medicine. It will combine GMP-certified manufacturing with an incubator for start-ups that includes labs, office space, and mentoring resources.

According to the announcement, ProBioGen will oversee build-out and certification of the GMP facility, supporting production of viral vectors, autologous and allogeneic cell products, non-viral technologies, and other biotherapeutics. Once operational, ProBioGen will manage day-to-day activities, provide training, and work with start-ups and industry partners.

Construction is scheduled to begin in 2025 with opening planned for 2028. The project is funded by Germany’s Federal Ministry of Research, Technology and Space and the State of Berlin.

Christopher Baum, scientific director of the BIH and chief translational research officer of Charité, said in a statement that the partnership ensures innovators have access to the expertise and production capacity needed to advance therapies.