- ProBioGen has received extended manufacturing authorization and an updated GMP certificate for its dedicated viral manufacturing facility in Berlin, Germany, covering sterile biological drug substances and investigational medicinal products, including viral vectors, viral vaccines and advanced therapy medicinal products (ATMPs).
- The facility provides up to 200L drug substance production capacity, in-house aseptic filling and adjacent quality control laboratories, enabling integrated services from process development through GMP manufacturing and filled-vial supply.
ProBioGen has received extended manufacturing authorization and an updated Good Manufacturing Practice (GMP) certificate for its dedicated viral manufacturing facility in Berlin, Germany. The authorization from the Berlin State Office for Health and Social Affairs (Lageso) establishes the regulatory foundation for manufacturing sterile biological drug substances and investigational medicinal products, including viral vectors, viral vaccines and advanced therapy medicinal products (ATMPs).
The authorization expands ProBioGen’s GMP manufacturing services beyond therapeutic proteins to include viral vectors and vaccines. The facility has drug substance production capacity of up to 200 liters, in-house aseptic filling and adjacent quality control laboratories. Its integrated setup supports activities from process development and GMP manufacturing through to filled-vial supply, reducing the need for customers to transfer products between different partners.
The facility was qualified in accordance with EU GMP Annex 1 requirements for sterile medicinal products and included three successful aseptic process simulations. Drug product filling uses an L1 system with restricted access barrier system (RABS) technology. Its contamination-control approach also includes pre-use post-sterilization integrity testing (PUPSIT) for filters used in sterile media and buffer preparation. These capabilities are particularly relevant for viral products for which sterilizing filtration is not suitable.
The facility will also manufacture GMP drug substance for a Minapharm-led program advancing a Bundibugyo ebolavirus vaccine candidate based on ProBioGen’s proprietary MVA-CR19 platform toward clinical evaluation. The program combines ProBioGen’s vaccine development and drug substance manufacturing expertise with Minapharm’s commercial drug product manufacturing capabilities in Egypt.
“The authorization allows the company to offer an integrated service covering process development, GMP drug substance manufacturing and aseptic drug product filling for clinical supply. The approval also provides a foundation for ProBioGen’s future activities at the Berlin Center for Gene and Cell Therapies, where the company will operate a planned GMP facility.”
ProBioGen COO Dr. Simon Bulling
