Tuesday, December 30, 2025 12:10:55 PM
Press Release
20 NOV 2025
Northwest Biotherapeutics Announces That Construction Activities Are Under Way For the First Grade C Manufacturing Suite in the Sawston, UK Facility
BETHESDA, Md., November 20, 2025 — 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.”
Men who are occupied in the restoration of health to other men, by the joint exertion of skill and humanity, are above all the great of the earth. They even partake of divinity, since to preserve and renew is almost as noble as to create.
Recent NWBO News
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- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 11/26/2025 05:15:34 AM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 11/25/2025 10:23:07 PM
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- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/14/2025 09:44:21 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/31/2025 04:29:10 PM
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