Northwest Biotherapeutics Announces That Construction Activities Are Under Way For the First Grade C Manufacturing Suite in the Sawston, UK Facility
BETHESDA, Md., Nov. 20, 2025 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB:NWBO) (the "Company" or "NWBio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced that it has engaged a construction firm to carry out the construction of the first Grade C manufacturing suite in the Company's Sawston, UK facility, the construction firm is onsite and the construction activities have begun. The Company anticipates that the manufacturing capacity of the first Grade C suite will more than double the aggregate capacity of the existing Grade B manufacturing suites combined. As such, the Company considers the construction of the first Grade C suite a major step towards potential large scale-up of the Company's production of DCVax® products.
Manufacturing of medical products such as DCVax must be done in clean room facilities in sterile conditions. When manufacturing equipment and procedures involve steps open to the air, the manufacturing must take place in Grade B suites with special air handling and other requirements which are extremely expensive both to develop and to operate. In addition, only one patient's product may be made in a Grade B suite at a time, and the whole suite must stop activity and be specially cleaned in between manufacturing one patient's product and the next. The manufacturing of living cell products in general has traditionally had to be conducted in Grade B suites.
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.
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 closed 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) per machine. 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."
About Northwest Biotherapeutics
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.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning plans for DCVax® are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "design," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those projected in any forward-looking statement. Readers should not rely upon forward-looking statements. There are a number of important factors that could cause actual results to differ materially from those anticipated, including, without limitation, risks related to delays or uncertainties in regulatory processes and decisions, risks related to the Company's ability to achieve timely performance of third parties, risks related to whether the Company's products will be viewed as demonstrating safety and efficacy, risks related to the Company's ongoing ability to raise additional capital, and other risks included in the Company's Securities and Exchange Commission ("SEC") filings. Additional information on the foregoing risk factors and other factors, including Risk Factors, which could affect the Company's results, is included in its SEC filings. Finally, there may be other factors not mentioned above or included in the Company's SEC filings that may cause actual plans, results or timelines to differ materially from those projected in any forward-looking statement. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
CONTACTS
Northwest Biotherapeutics
Dave Innes
804-513-4758
[email protected]
SOURCE Northwest Biotherapeutics, Inc.
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