NorthWest Biotherapeutics Inc (NWBO)

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Yes, DCVax-L manufactured at the Advent Facility
https://nwbio.com/northwest-biotherapeutics-announces-filing-of-application-for-license-for-commercial-manufacturing-at-sawston-uk-facility/

Northwest Biotherapeutics Announces Filing of Application for License for Commercial Manufacturing at Sawston, UK Facility
BETHESDA, Md., July 6, 2022 – Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced that an application for license of the manufacturing facility in Sawston, UK for commercial manufacturing of cellular therapies has been submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). The application builds upon the 3 licenses received for the Sawston facility in 2021.

This application for a Manufacturer’s license (MIA) represents the culmination of an additional year of intensive work, beyond the preparations over more than 2 years that were required for the applications for the initial licenses last year. The first license was received in September, 2021, from the Human Tissue Authority of the UK, and provided authorization for collection and storage of human tissues (such as the tumor tissue used to make the lysate for DCVax®-L products) and cells (such as the immune cells used to make DCVax-L). The second and third licenses were received in December, 2021, from MHRA, and provided authorization for manufacturing cellular therapies for use in clinical trials and compassionate use (“Specials”) cases, respectively.

As reported last year, a further license from MHRA is required specifically for commercial manufacturing of cellular products. Application for a commercial license requires meeting even higher standards.

Preparations for this commercial license have included the creation of a further 50 standard operating procedures (SOPs) and policy and technical specification documents, validation of transport and shipping, and full validation and qualification of seven new pieces of equipment. Each step in such validation and qualification processes incorporates user requirement specification, design qualification, installation/operational qualification and performance qualification. This takes many months for each item of equipment. Additional controlled rate freezers were also procured, validated and qualified to expand the cryostorage capacity at the Sawston facility.

An automated system for the fill and finish of DCVax-L product has also been delivered, installed, validated and qualified. “Fill and finish” is the final step of the process, after a batch of DCVax-L product has been manufactured, in which the batch is allocated into single doses in individual vials for cryopreservation and distribution.

Preparations for this commercial license application have also included successful recruitment of additional highly experienced, senior-level GMP experts and scientists. There is a significant shortage of such senior experts throughout the cell and gene therapy sector, and such personnel are in extreme demand. These additions bring significant additional capacity and depth to the Sawston team.

As was the case before, the preparations for this license application have taken place in the context of ongoing supply chain problems, personnel shortages and other post-COVID obstacles. For example, delivery of necessary equipment has been delayed months beyond the scheduled delivery dates. Certain reagents that are required ingredients for DCVax-L have been subject to ongoing supply shortages, and there is an ongoing worldwide shortage of the special caps required for the cell culture flasks used to make DCVax-L. The cumulative effects of these and other individual delays and shortages have been, and continue to be, substantial.

The next step for this license application will be another on-site inspection of the Sawston facility by MHRA – this time, inspecting the facility, its procedures, personnel, regulatory documents, capacity and capabilities in accordance with the standards for commercial manufacturing. Following the inspection, a report of the inspection results and any findings needing any corrective action will be issued by MHRA.

Following completion of any post-inspection actions, the Company is hopeful that a manufacturing license for commercial production of cellular products in the Sawston facility may be approved by year-end.

Such a manufacturing license is separate from any regulatory decision about approval of DCVax-L itself. The Company has not to date submitted an application for commercial approval of DCVax-L.

Dr. Mike Scott, President of Advent Bioservices commented “Our Team has put in an extraordinary effort to meet our self-imposed, end of Q2 deadline to submit the MIA application. The standards set for the manufacturing of commercially licensed advanced medicinal therapies are understandably extremely stringent. We now await scrutiny of the application and processes by the MHRA, and are ready to welcome their inspectors to the Sawston facility.”