Northwest Biotherapeutics, a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, and Advent BioServices, a contract development and manufacturing organization (CDMO) based in the UK, jointly announce that a manufacturer’s importation authorization (MIA) license has been approved and issued by the Medicines and Healthcare Products Regulatory Agency (MHRA) for commercial manufacturing of cell therapy products at the GMP facility in Sawston, UK.

According to the company, the MIA is one of the first licenses for commercial manufacturing of cell therapy products in the UK. 

The license is the culmination of more than three years’ work, including development of the facility, specialized personnel, standard operating procedures (SOPs) and systems, well over 1,650 regulatory documents, and a successful operating history under the initial manufacturing licenses previously obtained to produce cell therapies for clinical trials and compassionate use. All of this work was carried out by Advent BioServices under contract with NW Bio.

Under the commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (e.g., immune cells) may also be imported into the UK for production or release of cell therapy products under the facility’s licenses.

Linda Powers, CEO of NW Bio, said: “We are very excited to reach this major milestone, as it is an essential step towards submission of our application for regulatory approval of our lead product, DCVax-L. It is especially exciting to be able to operate globally from this base in the UK.”

Mike Scott, president of Advent BioServices, said: “It is always challenging to be one of the trailblazers. The field of personalized cell-based immunotherapy is rapidly evolving and we are collectively navigating our way through the regulatory landscape. We are therefore thrilled that the extensive preparatory work undertaken by our skilled and dedicated team has met the extremely high standards set for this commercial level of manufacturing license.”