The live virus and viral vector CDMO has provided an update on the build which features BSL 2 Grade B/C cleanrooms
Vibalogics has reached a major milestone in its $50m GMP Cuxhaven facility expansion with the new 500L manufacturing line.
The expansion will provide added capacity and scalable clinical solutions for virotherapy manufacturing.
The virotherapy contract development and manufacturing organisation (CDMO), which has recently been acquired by Recipharm, is focused on the production of live viruses and viral vectors.
Our current clients and potential future partners note the remarkable facility fit and modular nature of our site
The new building features biosafety level (BSL) 2 Grade B/C cleanrooms supporting host-cell expansion suites, upstream processing capacity at 500L single-use-bioreactor production, and separate downstream purification suites.
The increased capacity further enhances Vibalogics' flexibility, minimising time to clinic for its clients.
The expansion was led by Vibalogics' President and Managing Director, Stefan Beyer, who said: "I am excited to see such remarkable growth of our business over the past 19 years. Since 2003, Vibalogics has focused on services for the production of human therapeutics and vaccines and has grown significantly due to scientific advances in advanced viral modalities."
With the first construction milestone complete, Vibalogics will now progress GMP manufacturing campaigns for multiple clients currently contracted to the new building.
Capacity utilisation remains high for 2022, with some development and production contracts already extending GMP campaigns into 2024, however select opportunity to secure production through the expansion suites still remains.
The project is a part of an overall $50m investment into the 100,000 sqft (9,400 sqm) facility to support construction of additional cleanrooms, process development and quality control testing laboratories, and raw materials warehousing for Vibalogics' global clients.
Beyer continued: "Vibalogics is now planning the second phase of expansion in Cuxhaven through design and construction of additional process development and quality control testing laboratories set to commence early this year, and our new labs will be equipped by early 2023."
The campus currently provides fully integrated service offerings for preclinical through phase I-II oncolytic virus, viral vector gene therapy, and vaccine programmes.
The services offered include cell and virus banking, process and analytical development, drug substance manufacturing, drug product fill-finish of liquid and lyophilised products, quality control batch release testing, and stability studies. Late phase and commercialisation services are offered at Vibalogics' new Boxborough, MA facility, which was completed in late 2021 and provides its customers with a true end-to-end service for virotherapy products.
Led by Beyer's vision, the facility will continue to harness state-of-the-art technologies, building materials, as well as material and personnel flow that offer efficiencies, cost savings, and flexibility to cater to drug development companies' progressive needs into the future.
"Our current clients and potential future partners note the remarkable facility fit and modular nature of our site, and especially enjoy the visible state of our operations which leverage cleanroom glass exposure to live GMP operations" Beyer said. "We welcome clients into our facility to see their production processes as they are occurring and encourage person-in-plant opportunities as much as possible. Above all, we remain committed to our clients and growing our business with their continued interests in mind."