Northwest Biotherapeutics Announces That Construction Activities Are Under Way For the First Grade C Manufacturing Suite in the Sawston, UK Facility

When a medical product is able to be manufactured using closed equipment and procedures that are not open to the air, the manufacturing can be conducted in Grade C manufacturing suites which are much less onerous and expensive to operate. In addition, multiple or numerous patient products may be manufactured simultaneously in a single Grade C manufacturing, and only certain equipment (not the whole suite) must be cleaned between production batches. These differences can enable a major increase in throughput and capacity, together with efficiency gains in both staff and materials.

BETHESDA, Md., 20/11/2025 (informazione.news - comunicati stampa - salute e benessere)

When a medical product is able to be manufactured using equipment and procedures that are not open to the air, the manufacturing can be conducted in Grade C manufacturing suites which are much less onerous and expensive to operate. In addition, multiple or numerous patient products may be manufactured simultaneously in a single Grade C manufacturing, and only certain equipment (not the whole suite) must be cleaned between production batches. These differences can enable a major increase in throughput and capacity, together with efficiency gains in both staff and materials.

As the Company has previously reported, the Flaskworks system is specially designed to carry out the key manufacturing processes for DCVax-L products on a basis. Developing this system was particularly challenging because the DCVax-L manufacturing process includes the dendritic cells adhering like barnacles to the flasks containing them, and then the mature activated cells being harvested by detaching them without damaging or destroying them. The Company views use of the Flaskworks closed system as key to enabling DCVax-L production to begin taking place in Grade C suites rather than Grade B suites – and the Company views such transition to Grade C suites as central to large scale-up of production.

The Company's business plan currently envisions manufacturing being established in the Grade C suite in the Sawston facility during Q2 of next year, with the construction of the Grade C suite taking approximately 6 months, followed by equipment installation and validation.

As previously reported, Advent worked closely with construction and engineering experts to develop a design and location within the Sawston facility that is expected to enable this first Grade C manufacturing suite to be constructed on a simplified basis at significantly lower construction costs and faster timeline. The project will also involve several million pounds of equipment costs. For example, as noted in the Company's recent 10-Q report, the cost to purchase certain fundamental equipment new is about £800,000 (approximately $1 million ) . Fortunately, Advent has been able to secure some of the machines at reduced cost. Due to long lead times, the Company is necessarily already proceeding with certain equipment purchases now. 

"We are excited to be under way with the construction activity and equipment sourcing for the first Grade C lab in our Sawston facility," commented Linda Powers , the Company's CEO. "We view this as a transformative step in our progress toward large scale operations." 

Northwest Biotherapeutics is a biotechnology company focused on developing personalized immunotherapy products that are designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis. The Company has a broad platform technology for DCVax  dendritic cell-based vaccines. The Company's lead program involves DCVax -L treatment for glioblastoma (GBM). GBM is the most aggressive and lethal form of primary brain cancer, and is an "orphan disease." The Company has completed a 331-patient Phase III trial of DCVax-L for GBM, presented the results in scientific meetings, published the results in JAMA Oncology and submitted a MAA for commercial approval in the UK. The MAA is currently undergoing review. The Company has also developed DCVax -Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and plans to pursue Phase II trials this year. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania .

Dave Innes
804-513-4758  
dinnes@nwbio.com

Logo - https://mma.prnewswire.com/media/325355/northwest_biotherapeutics__inc__logo.jpg 

View original content:https://www.prnewswire.co.uk/news-releases/northwest-biotherapeutics-announces-that-construction-activities-are-under-way-for-the-first-grade-c-manufacturing-suite-in-the-sawston-uk-facility-302622271.html