Northwest Biotherapeutics Announces That Construction Activities Are Under Way For the First Grade C Manufacturing Suite in the Sawston, UK Facility
Northwest Biotherapeutics (OTCQB:NWBO) has begun on-site construction of the first Grade C manufacturing suite at its Sawston, UK facility. The company says the new Grade C suite will more than double the aggregate capacity of its existing Grade B suites and is viewed as a major step toward large-scale production of DCVax products.
The project timeline targets establishing manufacturing in the Grade C suite in Q2 2026, with construction taking about six months, followed by equipment installation and validation. Equipment costs are described as several million pounds, with individual machines noted at about £800,000 each new.
Northwest Biotherapeutics (OTCQB:NWBO) ha iniziato i lavori in loco per la prima suite di produzione di grado C nel suo stabilimento di Sawston, nel Regno Unito. L'azienda dice che la nuova suite di grado C più che raddoppierà la capacità aggregata delle sue attuali suite di grado B ed è considerata un passo importante verso la produzione su larga scala dei prodotti DCVax.
Il calendario del progetto punta a stabilire la produzione nella suite di grado C nel Q2 2026, con la costruzione che richiederà circa sei mesi, seguita dall'installazione e dalla convalida delle apparecchiature. I costi delle apparecchiature sono descritti come diversi milioni di sterline, con le singole macchine indicate a circa £800.000 ciascuna.
Northwest Biotherapeutics (OTCQB:NWBO) ha comenzado la construcción in situ de la primera suite de fabricación de Grado C en sus instalaciones de Sawston, Reino Unido. La empresa afirma que la nueva suite de grado C duplicará con creces la capacidad agregada de sus actuales suites de grado B y se considera un paso importante hacia la producción a gran escala de los productos DCVax.
El plazo del proyecto prevé establecer la fabricación en la suite de grado C en Q2 2026, con la construcción tomando alrededor de seis meses, seguida de la instalación y validación de equipos. Se describen los costos de los equipos como varios millones de libras, con máquinas individuales señaladas en aproximadamente £800,000 cada una.
Northwest Biotherapeutics (OTCQB:NWBO)가 Sawston, 영국 시설에서 첫 등급 C 제조 스위트의 현장 건설을 시작했습니다. 회사는 새로운 등급 C 스위트가 기존 등급 B 스위트의 총 생산능력을 두 배 이상으로 늘릴 것이며 DCVax 제품의 대규모 생산으로의 중요한 단계로 간주된다고 말합니다.
프로젝트 일정은 2026년 2분기에 등급 C 스위트에서 제조를 확립하는 것을 목표로 하며, 건설은 약 6개월가 걸리고, 이어 장비 설치 및 검증이 이루어집니다. 장비 비용은 수백만 파운드로 설명되며, 개별 기계는 대략 £800,000으로 명시되어 있습니다.
Northwest Biotherapeutics (OTCQB:NWBO) a commencé sur site la construction de la première salle de fabrication de catégorie C dans son établissement de Sawston, au Royaume-Uni. L'entreprise indique que la nouvelle salle de catégorie C dépassera de loin la capacité agrégée de ses salles actuelles de catégorie B et elle est considérée comme une étape majeure vers une production à grande échelle des produits DCVax.
Le calendrier du projet vise à établir la fabrication dans la salle de catégorie C au 2026 T2, la construction prenant environ six mois, suivie de l'installation et de la validation des équipements. Les coûts des équipements sont décrits comme plusieurs millions de livres, avec des machines individuelles indiquées à environ £800,000 chacune.
Northwest Biotherapeutics (OTCQB:NWBO) hat mit dem On-site-Bau der ersten Grade-C Herstellungsanlage in seiner Anlage Sawston, Großbritannien, begonnen. Das Unternehmen gibt an, dass die neue Grade-C-Anlage die gesamte Kapazität seiner bestehenden Grade-B-Anlagen deutlich verdoppeln wird und als wichtiger Schritt zur Großproduktion von DCVax-Produkten gilt.
Der Projektzeitplan zielt darauf ab, die Herstellung in der Grade-C-Anlage im Q2 2026 zu etablieren, wobei der Bau circa sechs Monate dauern soll, gefolgt von der Installation und Validierung der Ausrüstung. Die Kosten für die Ausrüstung werden als mehrere Millionen Pfund beschrieben, wobei einzelne Maschinen etwa £800.000 kosten sollen.
Northwest Biotherapeutics (OTCQB:NWBO) بدأت في الموقع بناء أول وحدة تصنيع من الدرجة C في منشأتها في سوسْتون، المملكة المتحدة. وتقول الشركة أن الوحدة الجديدة من الدرجة C ست تضاعف أكثر من قدرة وحداتها من الدرجة B الحالية وهي خطوة رئيسية نحو إنتاج DCVax على نطاق واسع.
يركز جدول المشروع على إقامة التصنيع في وحدة الدرجة C في الربع الثاني 2026، مع استمرار البناء لمدة حوالي ستة أشهر، ثم تركيب المعدات والتحقق منها. وتُوصف تكاليف المعدات بأنها عدة ملايين من الجنيهات، مع الإشارة إلى أن كل جهاز مُزود بمبلغ نحو £800,000.
- Manufacturing capacity to more than double existing Grade B suites
- Targeted operational start in the Grade C suite by Q2 2026
- Use of Flaskworks closed system enabling Grade C production
- Projected equipment investment of several million pounds
- Upfront equipment purchases now due to long lead times
- Significant capital required: individual machines ~£800,000
- Commercial timing depends on MAA review and validation steps
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
"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
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
dinnes@nwbio.com
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SOURCE Northwest Biotherapeutics, Inc.
FAQ
What did Northwest Biotherapeutics (NWBO) announce about the Sawston Grade C suite on November 20, 2025?
When does NWBO expect the Sawston Grade C manufacturing to be operational?
How much equipment investment did Northwest Biotherapeutics disclose for the Grade C project?
How will the Grade C suite affect DCVax production capacity for NWBO?
Why can NWBO produce DCVax in Grade C rather than Grade B suites?
What are the near-term risks investors should note about NWBO's Grade C build-out?
