US cancer tech ramping towards Cambridge production
US cancer technology company Northwest Biotherapeutics is hopeful of rolling out transformational product from its new Cambridge UK facility in Q3 of this year.
The Maryland company is developing DCVax® personalised immune therapies for solid tumour cancers.
It has applied to the Medicines and Healthcare Products Regulatory Agency (MHRA) for certification of the manufacturing facility in Sawston to produce Good Manufacturing Practice (GMP) clinical grade medical products for patients.
This application represents the culmination of more than two years of preparations, including more than a year conducting these efforts under challenging COVID-19 restrictions and conditions.
As previously reported in Business Weekly, the preparations have included the physical buildout of Phase I of the facility, development of over 500 regulatory documents (including Standard Operating Procedures) for all aspects of operations, batch manufacturing records, and other formal documents), development of a Cambridge team of nearly 40 people with all of the required types of expertise for production of Advanced Therapy Medicinal Products and training in regard to the DCVax® technology and processes.
The next step will be an on-site inspection of the facility by MHRA. Following the inspection, a report and any findings requiring corrective action will be issued by MHRA. Once everything meets MHRA approval Northwest Biotherapeutics is hopeful that an initial licence will be issued and production of GMP DCVax-L products in the Sawston facility may begin by around the end of Q3.
In addition to the MHRA submission activities, a prototype of the Flaskworks breakthrough system – designed to close and automate the manufacturing of cell therapy products such as DCVax® – has been delivered to the Sawston facility and the company anticipates that initial practice runs with the system may start in Cambridge this summer.
Meanwhile, manufacturing of vaccine products for compassionate use patients (‘Specials’) has been and is continuing at the GMP facility in London.