Northwest Biotherapeutics Begins Construction of Grade C Manufacturing Suite in UK Facility

“`html

BETHESDA, Md. – Northwest Biotherapeutics (OTCQB:NWBO), a biotech firm specializing in DCVax® personalized immune therapies for solid tumor cancers, has initiated construction of its first Grade C manufacturing suite at its Sawston, UK facility. The company anticipates that this new suite will more than double their existing Grade B manufacturing capacity, marking a significant step towards potential large-scale production of DCVax® products.

The construction activities are already underway, signaling a key milestone in the company’s strategy to streamline and expand its manufacturing capabilities. The move to Grade C manufacturing is particularly noteworthy due to the inherent challenges and costs associated with producing live cell therapies like DCVax.

Currently, the manufacturing of therapies like DCVax requires sterile Grade B cleanroom facilities when procedures involve steps open to the air. These suites are expensive to develop and operate, and typically only allow for the production of one patient’s product at a time, requiring extensive cleaning between batches. This process poses a significant bottleneck in scaling up production.

Grade C manufacturing suites, however, offer a more efficient alternative. By utilizing closed equipment and procedures that minimize exposure to the air, multiple patient products can be manufactured simultaneously, with only specific equipment requiring cleaning between batches. This translates to a substantial increase in throughput and capacity, along with efficiency gains in both staff and material usage.

The linchpin of Northwest Biotherapeutics’ transition to Grade C manufacturing lies in its Flaskworks system. This system is designed to carry out key manufacturing processes for DCVax-L products on a closed basis. The company acknowledges that developing this system, which allows for the gentle harvesting of dendritic cells without damage, was a complex undertaking. Success here is pivotal in enabling the shift from Grade B to Grade C suites, ultimately paving the way for large-scale DCVax-L production.

The company’s current business plan anticipates the Grade C suite becoming operational in Q2 of next year, following an estimated six-month construction period and subsequent equipment installation and validation. This timeline reflects the complexities and regulatory hurdles inherent in pharmaceutical manufacturing.

To mitigate costs and expedite the project, Advent worked with construction and engineering experts to optimize the design and location of the Grade C suite within the Sawston facility. While the project also entails several million pounds in equipment costs – with some individual machines costing around £800,000 (approximately $1 million) – Advent was able to secure some machines at a reduced cost. Due to necessary long lead times needed, the company is moving forward 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,” said Linda Powers, CEO of Northwest Biotherapeutics. “We view this as a transformative step in our progress toward large scale operations.” This move could significantly impact the company’s long-term profitability and market position within the personalized immunotherapy space.

Northwest Biotherapeutics is banking on the promise of DCVax® to offer cancer treatments with improved efficacy and reduced toxicity compared to traditional chemotherapies. Their lead program focuses on DCVax®-L for glioblastoma (GBM), a particularly aggressive form of brain cancer. The company completed a Phase III trial of DCVax-L for GBM involving 331 patients, presented the results, and published them in JAMA Oncology. They have already submitted a Market Authorization Application (MAA) to regulators in the UK, which is currently under review.

In addition to DCVax-L, the company is also developing DCVax®-Direct for inoperable solid tumor cancers. This underscores Northwest Biotherapeutics’ commitment to expanding the application of its dendritic cell-based vaccine technology across a range of oncological indications.

“`