NorthWest Biotherapeutics Inc (NWBO)

[The Danish Dude]

Still occasionally dropping by to bullshit, huh? Yeah you lot really working overtime this weekend spouting your oldies but goodies nonsense.

From Smith on Stocks article

MIA Manufacturer's Importation Authorization is required by the MHRA before a company can manufacture, import or export drugs. To qualify, a manufacturer needs to demonstrate to MHRA that it complies with good manufacturing practices (GMP) and can pass regular GMP inspections of its manufacturing site

https://nwbio.com/northwest-biotherapeutics-and-advent-bioservices-announce-receipt-of-license-for-commercial-manufacturing-at-sawston-u-k-facility/

20 MAR 2023
Northwest Biotherapeutics and Advent BioServices Announce Receipt of License for Commercial Manufacturing at Sawston, U.K. Facility

Under this 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 U.K. for production or release of cell therapy products under the facility’s licenses.

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.”

The MHRA granted a license for the import and export of living cells and tissue for Sawston. Tumor tissue and autologous cells necessary for the manufacturing of DCVax-L can be imported from anywhere in the world, processed into the final product and exported back to the point of origin. This means that Sawston can be used to provide product for worldwide commercialization.

This MIA is one of the first licenses for commercial manufacturing of cell therapy products in the U.K. To the best of NWBO’s knowledge, there are only two other such licenses, one of which was just granted. Under this commercial manufacturing license, cell therapy products manufactured in the Sawston facility may be exported globally. Products (autologous cells) may also be imported into the U.K. for production or release of cell therapy products under the facility’s licenses. This allows GBM patients anywhere in the world to send their resected tumor tissue to Sawston to have their personalized vaccine manufactured and then shipped back. So even before approval in a given country, patients with adequate financial resources might be able to access DCVax-L on a compassionate use basis.

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