Northwest Biotherapeutics has begun building its first Grade C manufacturing suite at its Sawston, United Kingdom facility, a move that will more than double the aggregate capacity of its existing Grade B suites. The new suite will enable the company to produce multiple patient‑specific DCVax products simultaneously under closed‑system conditions, a key step toward scaling up its lead therapy, DCVax‑L.
The construction start follows a Q3 2025 earnings report that showed a $26.8 million loss on revenue of $200 k, underscoring the company’s pre‑commercial status and ongoing capital needs. To fund the expansion, Northwest secured a $5 million convertible note, a financing that will also support ongoing research and development activities.
The shift from Grade B to Grade C is made possible by the company’s acquisition of Flaskworks’ closed‑system technology, which reduces the need for the highly restrictive Grade B environment. By moving DCVax‑L production to the more cost‑efficient Grade C suite, Northwest expects to lower operating costs and accelerate scale‑up, positioning the company to meet the anticipated demand once the UK Medicines and Healthcare products Regulatory Agency (MHRA) approves the therapy.
CEO Linda Powers said the new suite represents a “transformative step in our progress toward large‑scale operations.” She added that the investment will help the company transition from a research‑stage organization to a commercial‑ready manufacturer, a shift that is critical for capturing the market once regulatory approval is granted.
The expansion comes at a time when the oncology cell‑therapy market is growing rapidly, but also faces intense competition and regulatory scrutiny. While the new facility offers a competitive advantage in production efficiency, Northwest still confronts headwinds such as limited commercial experience, ongoing capital requirements, and the uncertainty surrounding the MHRA decision.
Overall, the construction of the Grade C suite signals Northwest’s commitment to scaling its manufacturing capabilities in line with its commercial strategy for DCVax‑L and DCVax‑Direct. If the company can deliver on its cost‑saving and capacity goals, the expansion could improve margins and accelerate the company’s path to profitability.
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