Northwest Biotherapeutics (NW BIO ), a Biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, has announced that approval has been received from the UK Medicines and Healthcare Products Regulatory Agency ( MHRA ) of a license for manufacture of GMP (clinical grade) Cell therapy products at its Sawston, UK facility.
The MHRA license approval enables the manufacturing of DCVax-L products to get under way at the Sawston facility in addition to continuing at the smaller GMP Facility in London. The license also permits the import and GMP manufacture of other Cell Therapy products under the UK’s supply of unlicensed medicinal products (‘Specials’) regime and for Clinical Trials under the Investigational Medicinal Products (IMP) Programme.
The company is developing the Sawston facility in phases, both to optimize the timing of capital requirements and to enable each phase to be state-of-the-art when developed, as manufacturing technologies are advancing significantly in the field of cell therapies.
To date, the company has developed Phase 1A of the facility, comprising approximately 4,400 square feet of the overall 88,345 square feet. The company anticipates that Phase 1A alone will be able to manufacture DCVax-L products for 45-50 patients per month, or 450-500 patients per year – a significant increase from the current manufacturing capacity of four to six patients per month which, to date, has been taking place in a GMP clean room facility in London, UK.
This MHRA license is a culmination of intensive preparations that have been underway for much of 2021. The process included an extensive application process, a week-long inspection of all aspects of the physical facility, its construction and equipment, all aspects of the facility’s operations, including all operating systems, flow of materials and activities, sterility, quality control, staff and other factors, and all of the regulatory documentation, including Standard Operating Procedures (SOPs) for the facility and for the product, Batch manufacturing records, data from practice manufacturing runs and other required documents.
This MHRA license follows the license approval by the UK’s Human Tissue Authority ( HTA ) in October. That license covers the collection, processing and storage of human tissue and cells for medical purposes, including cell therapies such as DCVax-L. The preparatory work and applications for the MHRA and HTA licenses have been carried out by Advent Bioservices, NWBio’s UK entity contract manufacturer, operator, and license holder.