ProBioGen has received extended manufacturing authorisation and an updated GMP certificate from the Berlin State Office for Health and Social Affairs (Lageso) for its viral manufacturing facility in Berlin.
The authorisation, issued in accordance with EU GMP Annex 1 requirements for sterile medicinal products, confirms the facility's GMP compliance and provides a regulatory basis for manufacturing sterile biological drug substances and investigational medicinal products.
These include viral vectors, viral vaccines and advanced therapy medicinal products (ATMPs), thus extending ProBioGen's GMP manufacturing services for therapeutic proteins to viral vectors and vaccines.
The Berlin facility was designed specifically for viral products, combining drug substance production capacity of up to 200 L with in-house aseptic filling and adjacent quality control laboratories.
The company touts its integrated services that "support timely testing and handling of sensitive products and intermediates," giving its customers continuity from process development through GMP manufacturing to filled vials.
The site is also gearing up to manufacture recombinant MVA drug substance for the Minapharm-led programme to advance a Bundibugyo ebolavirus vaccine candidate based on ProBioGen’s proprietary MVA-CR19 platform towards clinical evaluation.
The vaccine candidate — designed to induce both B- and T-cell responses — has been supported by CEPI funding to combat the escalating epidemic.
"This milestone builds on ProBioGen’s proven track record of more than two decades in GMP manufacturing of protein-based biopharmaceuticals, now combined with our deep expertise in viral vector technologies," said Dr Simon Bulling, Chief Operating Officer (COO) at ProBioGen.
The firm appointed Dr Bulling as COO in April this year to oversee manufacturing and lead ProBioGen's next phase of operational growth.
With the authorisation of our dedicated viral facility, we can offer an integrated service covering process development, GMP drug substance manufacturing and aseptic drug product filling for clinical supply.
"For our customers, this means greater continuity, fewer handovers and one integrated path from development to GMP supply — with quality, reliability and speed at its core."
The company added that the authorisation will provide an important foundation for its future activities at the Berlin Centre for Gene and Cell Therapies (BC GCT), a major public-private biotech hub currently under construction, also in Berlin.
Jointly initiated by Bayer AG, Charité Universitätsmedizin Berlin and the Berlin Institute of Health at Charité (BIH), the site will comprise a start-up incubator with capacity for 15-20 biotech start-ups and a 4000 m2 GMP manufacturing unit with seven cleanrooms.
ProBioGen will operate the future GMP facility at the centre, producing clinical trial supplies (phases I/II) for cell and gene therapies.
