Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, completed development of the initial production capacity of its Sawston, UK advanced manufacturing facility. The company currently anticipates that the certification application will be submitted to the UK MHRA within the next six to eight weeks.

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 sq.-ft. on two floors.  The initial production capacity includes two manufacturing suites, occupying approximately 4,400 sq.-ft. 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 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. With the initial team trained, the recruitment and training are now continuing to expand the team.  When the Sawston facility is fully operational, it is estimated that it will employ more than 300 highly skilled personnel, including many who may be trained through apprenticeships in the Sawston facility.

With the additional space at the Sawston facility, it is anticipated that capacity for third party production of other cell therapy products may be developed. 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.