Shares of Northwest Biotherapeutics jumped 12% or 6c to 65c per share, after announcing, earlier on Tuesday, that it and contract developer, UK-based Advent BioServices, have 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, U.K…Linda Powers, CEO of NW Bio, commented, "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." Dr. Mike Scott, President of Advent BioServices, commented, "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."
Published first on TheFly
