Vibalogics, a global contract development and manufacturing organization (CDMO), has today announced that it has initiated the first stage of a planned $50 million 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 100,000 ft2 (9,400 m2) to service process development, drug substance manufacturing, drug product fill, and quality control batch release & stability studies.
Initial site expansions will accommodate additional BSL-2 classified areas, featuring up to 500 L 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. 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 the latest harvest, filtration, and product purification technology, plus 32,000 ft2 (3,000 m2) 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.
Stefan Beyer, President and Managing Director of Vibalogics, commented “The virotherapy sector is at an exciting phase in its journey. 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 is set to increase its Cuxhaven workforce to 160 people or more, projected by 2024.
Tom Hochuli, Chief Executive Officer at Vibalogics, added, “Our ongoing investments continue to strengthen the overall capabilities of Vibalogics, making for more robust early-to-late phase and commercial services including starting material generation, cGMP viral production, and quality control analytical testing. We are excited at the continued progress being made globally, both in Cuxhaven, as well as the ongoing build of our new facility in Boxborough, MA. Soon, our customers will benefit from increased capacity and multi-geographical operations, an exciting milestone for the organization. 2021 marks a new era for Vibalogics as we grow to meet the needs of the virotherapy market and play an even greater role in helping drug companies deliver innovative new therapeutics and vaccines that transform patients’ lives for the better.”
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 140,000 ft2 (13,000 m2) late-stage and commercial facility and new global headquarters in Boxborough, MA. The U.S. project will total $150 million, covering redevelopment of the site, innovative new equipment and the recruitment of expert personnel.
“We are very 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”, expressed Beyer.
For the past 15 years Vibalogics has specialized in servicing oncolytic viruses, viral vector vaccines and viral vectors, and offers process development, manufacturing, quality control testing and fill-finish services for its industry partners.