Virotherapy GMP Site Expands to Enhance Flexibility
Contract development and manufacturing organization Vibalogics has initiated the first stage of a investment plan at its facility in Cuxhaven, Germany, which will expand early-to-late phase clinical virotherapy manufacturing capacity. The site is used as a GMP development, testing, and manufacturing facility for oncolytic viruses, gene therapies, and viral vector vaccines, offering services including process development, drug substance manufacturing, drug product fill/finish, quality control batch release, and stability studies.
The project team that worked on the facility included PHA-Phillipp Hess Associates, ipk GmbH, and Linde Architektur. Phase I construction will be completed, with cleanrooms supporting a fully operational 500 L bioreactor production line, by January 2022. Phase II construction will commence in January 2022. The Cuxhaven facility site size exceeds 100,000 sq. ft. (9,400 sq. meters) .
Lab Manager speaks to Stefan Beyer, president, managing director of Vibalogics, about this facility expansion and what it means for virotherapy manufacturing.
Arial image of the Vibalogics GMP facility in Cuxhaven, Germany.
VIBALOGICS GMBH
Q: What was the need for this facility? Is it replacing an outdated existing facility or accommodating new research/ a new program?
A: The upgrade of the facility at Cuxhaven, Germany, follows the news of Vibalogics’ expansion into North America. Vibalogics is in the middle of a three-year investment plan, which includes the construction of a 140,000 sq. ft. (13,000 sq. meters) late-stage and commercial facility and new global headquarters in Boxborough, MA. The US project will total $150 million, covering redevelopment of the site, innovative new equipment, and the recruitment of expert personnel to bolster our late phase and commercial offering.
The Cuxhaven site investment will enable us to expand our early phase support and to ensure seamless technical transfer to the new site at Boxborough. With this expansion, we will be able to offer best-in-class end-to-end development and manufacturing services for oncolytic viruses, gene therapies, and viral vector vaccines. Totaling $50 million (€43 million), the expanded Cuxhaven site will accommodate additional BSL-2 classified areas, featuring 500 L single-use-bioreactors for the manufacture of viral-derived products. As a result, the site will offer increased capacity for our customers to enhance flexibility and minimize their time to market.
Q: Is there anything particularly unique or groundbreaking about your facility or the design plan?
A: The facility was designed to enable individual customers to watch manufacturing processes in action through multiple glass enclosures for visibility inside the production rooms. Full separation of virus-free and virus-containing areas was also an important factor, accompanied by strict decontamination design considerations to reduce risk of cross-contamination of batches. This had to be achieved while bolstering flexibility with short change-over procedures between production runs and customers.
Q: What sorts of challenges did you encounter during the design/build process, and how did you overcome them?
A: Getting a facility up and running is usually driven by pressing time constraints, and the need for a closely managed budget. As a CDMO, flexibility of design and build is essential to meet the widest range of customer needs. Achieving the desired footprint is also key, to align with market demand. However, it is also important not to drastically overbuild, as this can lead to excess or under-utilized capacity, which can quickly increase overhead costs.
The Cuxhaven facility was an existing brownstone facility originally established as The Biocompetence Center, which allowed us to expand the current footprint more easily. At the same time, though, we did face some challenges due to the building’s original concept and design, and its applicability to our future intended use and purpose. COVID-19 also impacted the supply chain and procurement of project materials, but we factored it in early and adapted our planning. The situation also resulted in an increase of material prices, the need for early ordering, and the need to balance orders across multiple providers, such as the construction companies and equipment suppliers, to minimize pressures for both Vibalogics and suppliers.
The project was developed with aggressive timelines, and through the selection of highly qualified partners we minimized timeline risk. Thanks to the creative insight and support of designers, engineers, and our construction and facilities personnel, we were able to deliver a plan capable of meeting our needs. This new facility will also allow us to further build out and expand in the future as needed, and to be able to grow with key customers. We also now have an ongoing relationship with our design and build suppliers, which will allow us to quickly embark on new projects as needed in the future. Our design for the site allows for further expansions in future, and we have secured the support and relevant permits from the City of Cuxhaven for future work.
Q: If a similar facility or program were to look at your lab for inspiration, what do you think they will take away as an example of what they should also implement in their own lab?
A: As desired by our customers, the inspiration here was to have a highly functional design which would support a multi-product viral production facility. I think others can learn from the way we have harnessed state-of-the-art technologies, building materials, as well as material and personnel flow, which has enabled us to create a robust facility that will continue to be fit for purpose for many years to come. They will note the steps we have taken to allow for further expansion and build to grow with our customers’ changing needs into the future. The way we have established a runway for clients to carry their production needs from early-to-late clinic is another important feature to consider. We believe that many customers will take inspiration from many aspects of our facility designs, and will consider incorporating many of our ideas into their own sites in future to enhance their line flexibility while supporting robust, high-quality development and manufacturing.