Northwest Bio Seeks GMP Certification of Sawston Mfg. Facility

Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, applied for certification of the manufacturing facility in Sawston, UK with the Medicines and Healthcare Products Regulatory Agency (MHRA). The company also provided a process update on the DCVax-L Phase III Trial.

On May 7, the application package was submitted to the MHRA requesting the certification of the Sawston facility to produce GMP clinical grade medical products. This application represents the culmination of more than 2 years of preparations, including more than a year conducting these efforts under challenging COVID-19 restrictions and conditions.

The preparations have included the physical buildout of Phase I of the facility, development of over 500 regulatory documents (including Standard Operating Procedures (SOPs) for all aspects of operations, batch manufacturing records, and other formal documents), development of a Sawston team of nearly 40 people with all of the required types of expertise for production of Advanced Therapy Medicinal Products (ATMPs) and training in regard to the DCVax technology and processes. 

The next step will be an on-site inspection of the facility by MHRA. The Company is hopeful that an initial license will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3.

Meanwhile, manufacturing of vaccine products for compassionate use patients has been and is continuing at the GMP facility in London.