Northwest Biotherapeutics, Advent get license for cell therapy facility in UK
Mar. 21, 2023 6:51 AM ETNorthwest Biotherapeutics, Inc. (NWBO)By: Ravikash, SA News Editor3 Comments
sturti
- Northwest Biotherapeutics (OTCQB:NWBO) and Advent BioServices said that the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) approved and issued a MIA license to commercially manufacture cell therapy products at the GMP facility in Sawston, U.K.
- Northwest said this MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. and to its knowledge, there are only two other such licenses.
- "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 U.K," said Northwest CEO Linda Powers.
- Under the license, cell therapy products manufactured in the Sawston facility may be exported globally, and products such as immune cells may also be imported into the U.K. for production or release of cell therapy products under the site's licenses, the company added.
- Advent is a U.K.-based contract development and manufacturing organization (CDMO).