ProBioGen, a Berlin-based contract development and manufacturing organization (CDMO), has received an expanded manufacturing authorization and updated Good Manufacturing Practice (GMP) certificate for its dedicated viral manufacturing facility from the Berlin State Office for Health and Social Affairs (Lageso). The authorization covers the manufacture of sterile biological drug substances and investigational medicinal products, including viral vectors, viral vaccines, and advanced therapy medicinal products (ATMPs).

The authorization extends ProBioGen’s GMP manufacturing capabilities beyond therapeutic proteins to include viral products. According to the announcement, the facility has drug substance production capacity of up to 200 liters, in-house aseptic filling, and adjacent quality control laboratories. The integrated setup supports manufacturing from process development through drug substance production and filling for clinical supply, the CDMO said.

The facility qualification followed EU GMP Annex 1 requirements for sterile medicinal products and included three successful aseptic process simulations. Drug product filling uses an L1 system equipped with restricted access barrier system (RABS) technology. The contamination-control strategy also includes pre-use post-sterilization integrity testing (PUPSIT) of filters used to prepare sterile media and buffers. These measures are particularly relevant to viral products that cannot undergo sterilizing filtration, the company said.

The facility will manufacture GMP drug substance for a Minapharm-led program advancing a Bundibugyo ebolavirus vaccine candidate based on ProBioGen’s MVA-CR19 platform toward clinical evaluation. The program reportedly combines ProBioGen’s vaccine development and drug substance manufacturing capabilities with Minapharm’s drug product manufacturing operations in Egypt.

The authorization also supports ProBioGen’s planned role at the Berlin Center for Gene and Cell Therapies, a biotechnology hub under construction. The company is expected to operate the center’s future GMP facility, which is intended to expand manufacturing capacity for biological medicines, viral vectors, and advanced therapies.

The development follows ProBioGen’s July 2026 collaboration with VarmX, a Leiden, Netherlands-based biotechnology company, to develop a cell line for a second investigational Factor X therapeutic candidate. The CDMO launched its avian cell line platform in May to support manufacturing of recombinant modified vaccinia Ankara (MVA) vaccines and oncolytic viruses.