NorthWest Biotherapeutics Inc (NWBO)

[hyperopia]

marzan, I know the capacity of Sawston has been a question for many here, but there was far more high-level manufacturing questions addressed in that presentation that few on this board will understand, but some in attendance will certainly appreciate.

For example, what has actually been more of a concern to me is that a number of other gene and cell therapy companies like Bluebird, Mesoblast, Sarepta, BioMarin, Voyager, Astellas, and others, have been held up for approval by the regulators (mostly the FDA) due to various manufacturing issues, most frequently from inadequate assay development. Approved biological products are required to be accompanied by analytical tests to demonstrate safety, purity, and potency. This additional scrutiny may have been prompted because not enough attention was paid to manufacturing controls during the rapid approvals of the early gene and cell therapies, a couple of which have had subsequent manufacturing issues. (Novartis)

So it was very reassuring for me to see slides 9-15 which showed Northwest Bio’s assay development work, particularly the “next generation potency assay” developed by Shashi Murthy et al. at Flaskworks/NW Bio.

As I said, in that presentation, Northwest Bio addressed the significant manufacturing challenges encountered by other cell therapy developers, and it’s clear to me that they’re well prepared.