Vibalogics began the first stage of a planned $50 million dollar investment at its Cuxhaven, Germany facility, expanding early-to-late phase clinical virotherapy manufacturing capacity.
The investment by the CDMO, which specializes in the production of oncolytic viruses, viral vector vaccines, and viral vector gene therapy products includes the expansion of the cGMP facility exceeding an overall 100,000ft2 (9,400m2) to service process development, drug substance manufacturing, drug product fill, and quality control batch release and stability studies.
Initial site expansions will accommodate additional BSL-2 classified areas, featuring up to 500-liter single-use-bioreactors for the manufacture of viral-derived products. As a result, the site will offer increased capacity for its customers to enhance flexibility and minimize their time to market, according to a company official who adds that it will also ensure “seamless technical transfer” as applicable to Vibalogics’ soon-to-be-operational late-and-commercial phase facility in Boxborough, MA.
The BSL-2 capacity will also support additional cGMP cell bank production suites, and harvest, filtration, and product purification technology, plus 32,000ft2 (3,000m2) of high-bay warehousing and office space. In addition, the project will see Vibalogics purchase the facility outright, as the company currently leases the site.
Potential to transform healthcare
“The virotherapy sector is at an exciting phase in its journey,” says Stefan Beyer, president and managing director of Vibalogics. “More and more companies are joining the industry, embarking on new projects with the potential to transform healthcare. We’re investing in our infrastructure, technologies, and personnel at Cuxhaven to ensure we continue to meet fast-growing global market demand and offer the best possible service to our customers.”
Vibalogics expects the initial site expansions to be in place and ready for cGMP operations by January 2022, with further plans set to continue the same year for ongoing growth of the location. In addition, and a part of its ongoing expansion goals, “Vibalogics is committed to an aggressive hiring plan and set to increase its Cuxhaven workforce to 160 people or more, projected by 2024,” adds Beyer.
The upgrade of the Cuxhaven facility follows the news of Vibalogics’ expansion into the U.S. The company is in the middle of a three-year investment plan, which includes the build out of a 140,000ft2 (13,000m2) late-stage and commercial facility and new global headquarters in Boxborough. The U.S. project will total $150 million, covering redevelopment of the site, new equipment, and the recruitment of expert personnel.
“We are pleased to see how the market is taking up our capacity expansions. Existing customers, and particularly new customers have already made capacity reservations for 2022, but with our expansion, there will be availability at our U.S. and Europe facilities that we are excited to offer,” notes Beyer.
