NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

skitahoe,

The batch by batch product release by a “qualified person” like Dr. Mark Lowdell and up to 36 hours per batch made artisan almost a non starter until digitization. This reduced that product release time down but not nearly enough to keep up with demand being created. This came by improvements in vaccine manufacturing with less tumor tissue needed creating a larger qualifying patient population. Then indications increased to include rGBM, with the possibility that MHRA may also consider adding on lower grade gliomas. Besides this there is the expected desire to use this vaccine process off label.
Product release standards for cell therapies are more restrictive in the UK and EU than in the US. This made overcoming them a greater challenge but doing so creates a much easier pathway for clearing regulatory hurdles elsewhere. So when Flaskworks is ready in the UK it’s a shoe in elsewhere which makes everything able to move forward much more quickly with manufacturing agreements, partnerships or other. Best wishes.