NorthWest Biotherapeutics Inc (NWBO)

[Slave1]

Hey jesster64, good question and fair to ask.

Flaskworks is not making the batches right now. Advent Bio is the one doing the GMP manufacturing, and they are the same group that would be making it post-approval. So there’s no mismatch issue like the one you described with that other biotech.

The MHRA already accepted the manufacturing setup when they approved the Pediatric Investigation Plan using the same trial design and external controls. That confirms regulatory confidence in both the trial structure and the production platform.

📄 MHRA PIP decision (DCVax-L), August 2022:
https://cms.mhra.gov.uk/system/files/2022-09/mhra-100409-pip01-21.pdf

All batches for the Phase 3 trial, the UK Specials program, and ongoing compassionate use have been and continue to be manufactured at Advent’s GMP facility. That site holds a full MHRA license and has been under NWBO’s control since the acquisition of the UK facility from Cognate BioServices.

📄 NWBO Q1 2024 10-Q filing:
https://www.sec.gov/Archives/edgar/data/1072379/000141057824000741/nwbo-20240331x10q.htm

“On May 14, 2018, the Company entered into a DCVax-L Manufacturing and Services Agreement (‘MSA’) with Advent BioServices… The MSA provides for manufacturing of DCVax-L products at an existing facility in London.”

Flaskworks is being scaled for future automation and capacity expansion, but it is not involved in current GMP production. It has not yet been introduced into the regulatory workflow and is not replacing Advent at this stage.

📄 Same Q1 2024 10-Q filing: Flaskworks is described as under development and not yet used for GMP manufacturing.

This is further supported by MHRA regulations, which require all “Specials” manufacturing to occur at a fully licensed GMP facility. That license is held by Advent, not Flaskworks.

📄 MHRA Guidance on “Specials” Manufacturing:
https://assets.publishing.service.gov.uk/media/645e19f5ad8a03000c38b3bc/The_supply_of_unlicensed_medicinal_products__special_GN14.pdf