ProBioGen and the Berlin Institute of Health at Charité (BIH) have announced that ProBioGen will 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).
The BC GCT is a joint project of Charité-Universitätsmedizin Berlin, Bayer AG and Berlin Institute of Health at Charité (BIH).
The design and build of the 4600 sqm GMP manufacturing unit — an integral part of the BC GCT and envisioned as a powerhouse for translational medicine in Berlin — will be overseen by ProBioGen, which will then operate the facility.
Under the awarded contract, ProBioGen will be responsible for the build-out and certification of the GMP unit.
This will allow 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 the facility's daily operations and 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 organisation (CDMO), ProBioGen operates its own facilities near the BC GCT.
ProBioGen's expansion into operating the centre's GMP unit — located close to its existing sites — will increase flexibility and enable seamless scale-up from discovery to clinical manufacturing.
"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."
"We are proud to bring our in-depth understanding of science, expertise, technologies, resources and dedication to support the centre'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."