Vibalogics, a leading virotherapy contract development and manufacturing organization (CDMO) focused on the production of live– viruses and viral vectors, has announced the completion of its expansion project at its GMP facility in Cuxhaven, Germany.
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, minimizing time to clinic for its clients.
The expansion was led by Vibalogics’ President and Managing Director, Stefan Beyer, Ph.D., 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, Vibalogics’ growth strategy, and capital support from Ampersand Capital Partners.
With the first construction milestone complete, Vibalogics will now progress GMP manufacturing campaigns for multiple clients currently contracted to the new building. Capacity utilization 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 (€43 million) investment into the 100,000 ft2 (9,400 m2) 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 Cuxhaven campus currently provides fully integrated service offerings for preclinical through phase I-II oncolytic virus, viral vector gene therapy, and vaccine programs. The services offered include cell and virus banking, process and analytical development, drug substance manufacturing, drug product fill-finish of liquid and lyophilized products, quality control batch release testing, and stability studies. Late phase and commercialization services are offered at Vibalogics’ new Boxborough, MA facility, which completed 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. 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.”
Company partners supporting the recent expansion include Pharma CMC Roland Reisinger, PHA Philipp Hess Associates, Bosch Sicherheitssysteme GmbH, Siemens AG, Baumeister Wilhelm Lüdke Stahlbeton-, Hoch- und Tiefbau GmbH & Co. KG.
About Vibalogics
Since 2003, Vibalogics has operated as a specialized global CDMO offering process and analytical development, manufacturing, testing, and fill-finish services to innovators developing transformational virotherapy products. From its headquarters and commercial facility in Boxborough, MA, USA and operations in Cuxhaven, Germany, Vibalogics supports its customers in the development and commercialization of oncolytic viruses, gene therapies.
