Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK Facility
FOR IMMEDIATE RELEASE
Northwest Biotherapeutics Announces Development Completed for Initial Production Capacity of Sawston, UK Facility
Application for MHRA Regulatory Certification of Facility In Preparation
BETHESDA, Md., March 16, 2021 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that development of the initial production capacity of the Company’s Sawston, UK advanced manufacturing facility has been completed and the facility is now in the final stages of preparation for an application for certification by the UK Medicines and Health Products Regulatory Authority (“MHRA”).
To date, the Company’s production of dendritic cell vaccine products in the UK has been taking place in a GMP (clean room) facility in London, with a capacity of about 4 – 6 patients per month. The Sawston facility contains a total of 88,345 square feet on two floors. The initial production capacity comprises two manufacturing suites, occupying approximately 4,400 square feet on the ground floor. These two suites, together with some additional support and storage space, have a potential production capacity of dendritic cell vaccines for about 40 to 45 patients per month, or approximately 450 to 500 patients annually, subject to regulatory approval.
An intensive recruitment program has been underway for well over a year, and has successfully hired and trained the necessary 30 senior technical managers, scientists and staff technicians and operators for manufacturing, quality control and other operations of the first two production suites. The recruitment process for experienced personnel with these types of expertise is highly competitive because the cell therapy and immunotherapy fields are growing rapidly and the pool of experienced specialists is very limited. With the initial team of 30 specialists on board and trained, the recruitment and training are now continuing to expand the team. When the Sawston facility is fully built out and in full operation, it is estimated that it will employ in excess of 300 highly skilled personnel, including many who may be trained through apprenticeships in the Sawston facility.
Since the initial dendritic cell vaccine production capacity will occupy only a small fraction of the total space in the Sawston facility, it is anticipated that additional capacity for third party production of other cell therapy products may be developed in some of the other space. GMP facilities are capital intensive both to develop and to operate. Third party production of other products will help support the Sawston facility costs and, in light of the growing demand for cell therapy manufacturing capacity, could substantially increase the asset value of the Sawston facility. The capacity for production of other products will also be an important resource for the region.
Development of the Sawston facility has been under way for more than two years, and has progressed on parallel tracks in multiple areas, including physical buildout of the first two production suites, equipment procurement and validation, specialized operating systems, drafting of regulatory documents, and recruitment and training of key scientific and technical personnel for the first two production suites.
All of the development activities for the Sawston facility have been carried out under contract with Advent BioServices, who is also the operator of the facility.
The facility is now in the Performance Qualification (PQ) stage, following completion of the Design Qualification (DQ), Installation Qualification (IQ), and Operations Qualification (OQ) stages. Each of these stages has taken many months of work. In the PQ stage, practice runs are conducted for months and the performance data is collected to show that the operations meet all of the applicable regulatory requirements (sterility, quality control testing, etc.). Those data then form a major part of the application to MHRA for certification of the first phase of the facility. The Company currently anticipates that the PQ stage will be completed and the certification application will be submitted to MHRA within approximately the next six to eight weeks.
The physical buildout of Phase 1a of the facility was carried out last year, and was completed ahead of schedule at the beginning of October despite COVID operating restrictions, by having the contractors work double shifts and other special measures. Advent BioServices worked with R.G. Carter as the general contractor.
R.G. Carter and its team of sub-contractors did an exceptional job of overcoming the COVID related difficulties and achieving the early completion. For example, they enabled and managed double shifts throughout the project, worked out special operating arrangements to enable construction to proceed in a socially distanced manner, found alternate sources for specialized materials when the original suppliers were unable to deliver, and made special travel arrangements to bring European equipment vendors’ installation engineers to Sawston. The Company is grateful to R.G. Carter and its sub-contractors for these special arrangements and solutions, and is looking forward to working with this team on subsequent phases of the Sawston facility.
Phase 1a cost approximately £3.5 million ($4.6 million), including the double shift costs, and covered the support facilities for the first two manufacturing suites, which had already been built. Approximately £1.35 million ($1.77 million) of the Phase 1a cost was funded through a competitive loan from the Cambridgeshire and Peterborough Development Authority. This funding was instrumental in enabling the Sawston facility to reach initial manufacturing readiness. The Company is very grateful to the Development Authority for this funding, and is looking forward to continuing to work with the Authority.
Following the physical buildout, the extensive and specialized equipment was sourced, installed, tested and validated. The COVID circumstances posed a number of difficulties. For example, there were supply chain and delivery difficulties to obtain the equipment. In addition, foreign vendors were unable to travel to the UK to conduct the installation, testing and validation as would usually occur. UK personnel had to go through training to conduct these activities instead of the vendor. The data from the testing and validation of each individual piece of equipment is required for the application package for certification of the facility. This work is now in the process of being completed.
Certain specialized operating systems (environmental management systems, quality management systems, lab information management systems and others) are required to measure, tightly control and collect data on air flow sterility and turnover, particle counts, and other conditions, as well as lab operations. The sourcing, installation, testing and validation of these specialized systems also encountered difficulties due to COVID, but are now nearing completion.
In parallel with the physical buildout, the equipment and the specialized operating systems, an intensive program has been under way to draft the necessary SOPs (standard operating procedures) and other regulatory documents. SOPs are tailored to a specific facility and cannot be procured ready-made. Detailed SOPs must cover every aspect of the facility’s operations, from the time supplies arrive at the loading dock and are placed in quarantined storage all the way through to the release of finished doses of the dendritic cell vaccines to the physician and patient. Over 500 SOPs and other regulatory documents have been drafted and tested over the last year-plus period, involving many, many thousands of man hours. This set of regulatory documents is now essentially complete for the initial launch of product manufacturing in the Sawston facility.
As previously reported, the Company has also been moving forward on optimization of the Flaskworks system for manufacturing of dendritic cell vaccines. The buildout of the Sawston facility is purposefully being done in phases, both for efficiency in the timing of capital costs and to allow flexibility in operations and usage. It is anticipated that implementation of the Flaskworks system will enable the buildout of some or all of the rest of the 88,345 square foot facility, beyond the initial manufacturing suites, to be simplified and streamlined at reduced cost.
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing personalized
immunotherapy products designed to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both North America and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 331-patient Phase III trial of DCVax®-L for newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” This Phase III trial is now completed and locked down, with announcement of top line data expected in the coming months. The Company is also pursuing development of DCVax®-Direct for inoperable solid tumor cancers. It has completed a 40-patient Phase I trial and, as resources permit, is preparing for Phase II trials. The Company previously conducted a Phase I/II trial with DCVax-L for advanced ovarian cancer together with the University of Pennsylvania.
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, 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. We cannot guarantee that we actually will achieve the plans, intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate 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 results 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.